BioForum Can life sciences find sustainable growth in the ... · as reported in the latest PwC...

BioForum

Edition 30

Published: December 2009

Quarter 1 FY10 July–September 2009

Can life sciences find sustainable growth in the upturn?

What would you like to change?

Momentum builds as investors returnSmaller cap stocks remained the driving force in the life science sector in Q1 FY10. The Life Science Index ex majors posted solid returns for a third consecutive quarter, growing 31.2 per cent and outperforming both the ASX All Ordinaries (up 20 per cent) and NASDAQ Biotech Index (up 12 per cent).

Contributing to this stellar performance was continued M&A interest from overseas, including LEO Pharma’s USD$290 million acquisition of Peplin.

In contrast, the broader Life Science Index rose just eight per cent over the quarter. This reflected the relative underperformance of the majors, which have been exposed to a strengthening Australian dollar. The US Federal Trade Commission’s decision to block CSL’s takeover of Talecris was another contributing factor.

Performance in detailThe Life Science Index ex majors has emerged from 2008’s historical lows, posting annual growth of 40 per cent and helping the sector make up lost ground.

Smaller cap medical device stocks were standout performers over the past 12 months. A select group of companies drove a 37 per cent annual increase in the ex major medical device subsector even though only one-third of this subsector experienced share price gains over the year.

On a rolling annual basis, the ex majors’ annual increase of 40 per cent is in stark contrast to the performance of the broader Life Science Index, which was down 1.4 per cent for the year. Both life science indices outperformed the All Ordinaries, which was down 16.4 per cent for the year.

This time last year majors such as CSL, rather than smaller cap stocks, were driving the sector. This reversal is an encouraging sign, suggesting a perceived value is there.

The ex majors’ performance suggests the sector is experiencing a sustained upturn rather than a rebound. It is building up a head of steam which is unlikely to dissipate in the foreseeable future.

IPOs and secondary financingIPO activity remained at a standstill in Q1 2010, in line with the US trend. Only two biotech IPOs took place in the US, but they raised US$1.2 billion. Talecris raised most of that total – US$1.1 billion – after the FTC blocked CSL’s takeover bid. However, the ASX is eagerly awaiting IPO activity from potential candidates such as CBio, PolyNovo and MDSystems.

Secondary financing bids received strong support during the quarter, with the total raised up from A$129 million to A$168 million. The increase was greatest in the medical device sector, which raised A$101 million. This was led primarily by US institutional support for Heartware, which was forced back to the market after the FTC blocked Thoratec’s takeover.

Institutions once again led secondary raisings overall, continuing the trend from the previous quarter. Other investors are also re-entering the market. While six months ago companies had their backs against the wall and were forced to raise capital at low valuations, now valuations are increasing.

US investment on the rise There was renewed investment in the US during the quarter with secondary raisings totalling US$2.6 billion, a twofold increase on the previous quarter.

This reflected venture capital (VC) trends during Q4 FY09, as reported in the latest PwC MoneyTreeTM Report and featured in this edition. Life science companies captured US$1.5 billion in VC funding, which was a 47 per cent increase from the prior quarter, and accounted for 41 per cent of all VC investment.

In addition, venture-backed M&A exits totalled US$2.6 billion with life science companies accounting for seven deals amounting to US$1.4 billion of this total. Healthcare reform being driven by the US stimulus package is also expected to promote interest in US companies and help them attract additional funding.

Featuring AvitaThis edition features a number of thought leadership articles and a company profile. We hear from Avita Medical, an ASX-listed company which has been transformed over the past two years as it continues to develop respiratory and regenerative medicine technologies.

Also included are an update on R&D tax incentives and the latest PwC MoneyTreeTM Report, titled “Reversing course?”, which looks at VC investment trends in the US life science sector.

i | PricewaterhouseCoopers

Craig Lawn PricewaterhouseCoopers

Tony Gellert PricewaterhouseCoopers

Manoj Santiago PricewaterhouseCoopers

PricewaterhouseCoopers AustraliaLife Sciences and Innovation Practice contacts

Australian Industry Leaders – Life SciencesCraig LawnPhone: +617 3257 5672Email: [email protected]

Manoj SantiagoPhone: +612 8266 4494Email: [email protected]

SydneyPrivate Client Services – AssuranceManoj SantiagoPhone: +612 8266 4494Email: [email protected]

Private Client Services – TransactionsKate JuliusPhone: +612 8266 5835Email: [email protected]

Private Client Services – AdvisoryTony GellertPhone: +612 8266 5776Email: [email protected]

Private Client Services – AdvisoryAdrian BunterPhone: +612 8266 5099Email: [email protected]

Private Client Services – Tax & AccountingCraig McIlveenPhone: +612 8266 2261Email: [email protected]

Private Client Services – TaxStephanie FabianPhone: +612 4925 1278Email: [email protected]

Pharmaceutical Industry LeaderJohn CanningsPhone: +612 8266 6410Email: [email protected]

Financial AssuranceMichelle ChiangPhone: +612 8266 7575Email: [email protected]

R&D TaxSandra MasonPhone: +612 8266 0470Email: [email protected]

Financial AssuranceIan BenhamPhone: +612 8266 2409Email: [email protected]

Licensing and Forensic AccountingCassandra MichiePhone: +612 8266 2774Email: [email protected]

Legal – Commercialisation & IPMegan DyballPhone: +612 8266 6333Email: [email protected]

Brisbane MelbourneCraig LawnPhone: +617 3257 5672Email: [email protected]

Nadia CarlinPhone: +613 8603 6616Email: [email protected]

Troy MorganPhone: +617 3257 8934Email: [email protected]

Sam LobleyPhone: +613 8603 3689Email: [email protected]

Quarterly key findings 1

Feature articles 3

Market performance 19

Performance overview 20

Quarterly financing 22

Yearly financing 23

Top 10 performers 24

Bottom 10 performers 25

Announcements – Australia 27

Partnerships 28

Mergers, acquisitions and divestments 30

Clinical trials 31

Regulatory 33

Other news 35

Announcements – US 39

Partnerships 40

Mergers, acquisitions and divestments 41

Clinical trials 44

Regulatory 45

Appendix 51

Companies in the PwC Life Sciences Index 52

Methodology 54

Acknowledgements 55

Contents Con

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Quarterly key findingsMarket performance Page number

Total market cap of the life sciences industry at end of quarter A$33,541m 20

Quarterly change in the life sciences industry 8.2% 20

Total market cap of the pharma/biotech sector at end of quarter A$24,426m 21

Quarterly change in the pharma/biotech sector 7.1% 21

Total market cap of the medical device sector at end of quarter A$9,114m 21

Quarterly change in the medical device sector 11.2% 21

Individual company performance

Top individual performer Prima BioMed Limited 24

Change in market cap over the last 4 quarters 2400% 24

Bottom individual performer Fermiscan Holdings Limited 25

Change in market cap over the last 4 quarters - 78% 25

Financing

Number of Australian life sciences companies that IPO’ed 0 22

Total market cap injected into the Australian life sciences index through IPOs 0 22

Number of US life sciences companies that IPO’ed 2 22

Total capital raised in US life sciences IPOs A$1,215m 22

Number of Australian life sciences companies that had secondary raisings 41 22

Total capital raised in Australian life sciences in secondary raisings A$168m 22

Number of US life sciences companies that had secondary raisings 57 22

Total capital raised in US life sciences in secondary raisings A$2,589m 22

Announcements

Australian

Total number of partnerships formed this quarter 46 28

Total number of mergers and acquisitions 16 30

Total announcements for clinical trials 47 31

Pre-clinical 10 31

Phase I 20 31

Phase II 11 32

Phase III 6 32

Total number of regulatory announcements 33 33

US

Total number of partnerships formed this quarter 16 40

Total number of mergers & acquisitions 85 41

Total announcements for clinical trials 31 44

Pre-clinical 0 44

Phase I 0 44

Phase II 1 44

Phase III 6 44

Total number of regulatory announcements 135 45

BioForum: July – September 2009 | �

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Feature articles

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Avita develops a growth culture

CEO William Dolphin gives an overview of the company and its prospects at the new frontier of regenerative medicine.

What is Avita’s history?Avita was formed in 2008 through the merger of Visiomed and Clinical Cell Culture (C3). Visiomed commercialised respiratory medical delivery products and was profitable while C3 was focused on the early stage of product commercialisation in the field of regenerative medicine. Essentially, the companies merged to acquire high-quality people, intellectual property and additional capital.

I was CEO of Visiomed and met Dalton Gooding while he was chairman of C3. He brought me onboard at Avita and is now Avita’s chairman. There is no getting around the fact that C3, as a high-flyer for a period, had disappointed a lot of investors.

When I joined Avita in July 2008, the board and management conducted a comprehensive review of the company, after which we brought in a new management team and overhauled our manufacturing, sales strategy and regulatory processes. The excellent results we have achieved since confirm the success of this restructuring.

Regenerative medicine, which includes products such as Avita Medical’s flagship ReCell® Autologous Spray-On Skin, is one of the fastest growing areas in healthcare and offers vast potential for companies seeking to address unmet therapeutic needs. Avita is rapidly gaining recognition as a key player in this emerging field.

At the moment, our respiratory division, which remains profitable, is our bread and butter. We believe that we have close to a 75 per cent share of the Australian spacer market. Revenues from our respiratory products provide a stable cash flow with which to continue developing our regenerative and tissue-engineered products.

What are Avita’s lead services/products and what is the commercial case for them?We have two primary product groups: our respiratory and regenerative medicine lines.

The respiratory line consists of two product ranges, Breath-A-Tech®, which is the leading spacer for adolescents and adults in Australia, and the Funhaler® Incentive Spacer, addressing the needs of the paediatric market.

While the respiratory market is a large and growing sector we believe that the field of regenerative medicine – and our regenerative technology specifically – offers by far the greater potential for growth, hence this is the focus of Avita’s efforts.

Regenerative medicine is the frontier of medical science and is revolutionising healthcare.


process, especially in the new FDA regulatory environment. C3 misjudged its regulatory strategy and had two false starts with the FDA. We have been working closely with the FDA and investigational sites in a collaborative manner and we’re confident that the study will yield positive outcomes and strong marketing claims.

What are your key strategies for growth and sustainability?We will continue to support our respiratory product sales to provide free cash flow as we drive commercialisation of our regenerative products.

We’ve developed a three-year plan that will position us for sustainable growth and profitability. Year one, 2008-09, was a year of restructuring and refocusing the company. Year two is a year of building the business: building a sales team, establishing ReCell as the standard of care at key sites in our major markets, getting our key opinion leaders and champions on board in each market and getting necessary clinical studies in place to support our marketing claims and regulatory approvals. Year three will be the year of growth: generating significant sales in Europe, China and Asia-Pacific, completing the US FDA trial and commencing sales in the US.

Avita has taken a decidedly different tack to C3, which was using a mass market approach and immediately appointed 38 distributors in more than 40 countries. The problem was that, while distributors are good for established products, with rare exceptions, they are not successful at introducing paradigm shifting technologies such as ReCell.

We are taking a very focused and structured approach to building the market from the ground up, establishing a base of highly influential users at a limited number of key sites, or centres of excellence, where ReCell is setting the standard of care within each market. This will build a firm foundation upon which the wide scale adoption of the technology will follow organically.

Our regenerative product, ReCell, incorporates a standalone cell harvesting, processing and delivery technology for the treatment of a wide range of wounds, burns, scar remodelling and other skin defects and injuries. ReCell is the first commercially available bedside cell therapy using regenerative techniques. The US Department of Defense, which has funded a study with ReCell, describes the product as a disruptive and “transformational technology” which is “redefining the clinical treatment of burn wounds and skin injuries”.

ReCell allows the surgeon to prepare and reapply a small quantity of the patient’s own healthy cells to a wound site. The applied tissue rapidly regrows to produce new, healthy, normally pigmented ‘baby’ skin within 5-10 days.

In a true breakthrough, the procedure is performed entirely onsite at bedside using a patented and proprietary spray-on application technique. The entire procedure takes approximately 30 minutes to complete and requires no laboratory facilities, off-site culture of tissue or specialised staff.

Every year in the US, Europe and Australia there are some 450,000 burns cases requiring surgery. Additionally, in these same markets, approximately 1.2 million patients seek treatment from plastic surgeons for scar remodelling and 1.7 million seek surgical treatment for skin discolouration, acne scarring, stretch marks and other skin defects. A substantial percentage of burns patients, scar remodelling cases, vitiligo sufferers and patients seeking aesthetic treatment for other skin defects are potential candidates for treatment with ReCell, representing a potential 2.5-3 million users per year.

ReCell has been demonstrated to reduce length of hospital stay and patient care costs and to deliver improved outcomes. There is a compelling value proposition for this technology when you look at the total cost of patient treatment.

ReCell is now commercially available in Europe and Australia where it is gaining acceptance, and was recently cleared for China, a potentially huge, though highly complex, market.

We are currently initiating clinical trials to obtain approval from the US FDA, a difficult and sometimes frustrating


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We will continue to work with government agencies and apply for grants as appropriate. Avita recently received a US$1.5 million grant from the US Armed Forces Institute of Regenerative Medicine (AFIRM) to accelerate approval of the company’s ReCell Autologous Cell Harvesting device in the US. Similarly, the French Ministry of Health has funded a €1.2 million study to demonstrate the medical effectiveness and economic benefits of ReCell to the hospital and healthcare system as compared to current standard of care.

We have always considered growth through partnering and have a successful licensing agreement in place for our respiratory technology with Respironics, a subsidiary of Philips. We’ve been approached by, and continue conversations with, a number of substantial companies in the regenerative medicine and wound care space. While such partnerships provide potential benefits – for instance, wider distribution networks and access to capital and staff – there are potential downsides as well, including loss of control of your market. As your product is one among many, you may not get the priority you hope for or, in some instances, the product may be buried. So, while we are certainly open to partnering, it requires a very circumspect approach. I never underestimate the Machiavellian tendencies of these potential benefactors.

Many life science companies find offers from multinationals too good to refuse as they are strapped for cash. We’re in a fortunate position as our respiratory products provide us with good cash flow. We’d like to take a measured and steady approach and create tangible value for shareholders before jumping into a partnering arrangement.

Looking further into the future, we aim to continue growing our revenue to become a $50 million company within a few years. That said, we are aware of the dangers of growing too quickly and we want to avoid the scenario in which a company raises capital and grows its market cap to $100 million on blue sky promises but has not proven it can bring a product to market. The result is often a boom and bust valuation spike which benefits no one.

How do you select your target market?We start by selecting markets that will most quickly provide a strong customer base to drive sustainable growth. Regulatory regimes and the health economics are also considerations. For example, in France and Germany, two current target markets, the medical fraternity is willing to work with novel technologies. These countries also have suitable regulatory environments and favourable healthcare funding programs.

ReCell is a great example of a product which addresses the needs of all stakeholders: it reduces costs in the care and treatment of patients due to decreased hospitalisation times and reduced requirement for medications and nursing care; it meets the concerns of healthcare systems; its ease-of-use and reduced morbidity is attractive to surgeons; and it reduces pain and greatly improves outcomes for patients.

We need to address each group: procurement officers at hospitals and clinics and, at the governmental level which is charged with reducing costs, doctors and surgeons who are willing to try out and adopt new technologies to improve results, as well as patients seeking the best treatment.

In the case of ReCell, we are fortunate in that we are not a ‘me too’ product. We have no direct technology competition; hence it is not a case of needing to differentiate our product as one among many. Instead, our competition is not a competing product but an existing process, namely skin grafting which is the current standard of care.

What are Avita’s key assets?We have both a mature respiratory product line which is a cash cow and a regenerative line with revolutionary potential that we hope will become our star product.

To protect our IP, we have broad patents in place which capture key aspects of our regenerative and respiratory technologies. With regards to our regenerative IP the key components of our technology include the processing of tissue, the delivery of living cells, in vivo regeneration of tissue and a self-contained device in the form of a small disposable kit. We are continuing to work with our patent attorneys in the US to expand our IP.

The merger presented us with an opportunity to put in place a world class management team and board. We have a staff of 13 with offices in Cambridge UK, Boston USA and Perth, Australia. This geographic spread makes it a challenge to regularly communicate face to face, but with telecommunications and video conferencing, this can be overcome.

Can you explain how your regenerative technology works?Regenerative medicine captures processes that the body uses in its initial embryonic development, then directs and amplifies these processes to promote cellular growth and renewal to treat injured, diseased or failing organs and tissues.

Essentially, Avita’s technology harnesses the body’s innate ability to heal itself and packages it into an easy-to-use kit for the surgeon or clinician.

The current standard treatment for a burn injury is skin grafting, little changed from the approach used since the early 1900s. To cover a wound, a large piece of skin is removed from another region of the body, the leg or back for instance, and then stapled or glued over the wound site. While this approach works in most cases, a large secondary wound is created at the donor site, the patient is hospitalised for an extended time and requires very expensive wound dressings, immunosuppressive and pain medications and extensive nursing care. The patient suffers through a very painful process and is left with major scars at the donor and original wound sites. ReCell changes the equation, significantly reducing hospitalisation time and treatment costs while providing vastly improved outcomes.

Instead of a large skin graft, our process takes a very thin postage-stamp size piece of skin, termed a biopsy, from near the wound. The biopsy is incubated in an enzyme cocktail which breaks down the tissue, leaving the live constituent skin cells and a large population of undifferentiated basal cells with stem-cell-like properties. The cells are then mechanically agitated and buffered, creating a cell suspension which is sprayed onto the wound.


The disaggregated and activated cells enter into a phase of high mitotic activity, rapidly proliferate, differentiate and migrate over the wound surface. Within roughly 10 days entirely new skin has regenerated, matching the original skin at the wound site in colour, texture and sensitivity; hence there is no scarring, full recovery of function and beautiful new skin.

What keeps you awake at night?The possibility of making a critical strategic mistake.

The regenerative technology manifested in ReCell works extraordinarily well, but a great technology or product is only part of the battle. We’ve all seen companies with great potential go off the rails due to a strategic error – certainly C3 fell into that category.

It is crucial that a company have an unambiguous strategic plan in place, including clearly defined goals and timelines, and that both the plan itself and the company’s performance against plan are critically assessed on a continuous basis. This requires relentless honesty and an unemotional evaluation of progress to plan.

This certainly doesn’t mean not being passionate about the product or technology – quite the contrary, and I most definitely am – but it does require that one not fall in love with the technology and lose the necessary perspective to critically evaluate your product vis-à-vis market needs and wants and the reality of achieving your goals. Too often

I’ve seen management misjudge and overestimate the attractiveness or need for their product with the result that they overestimate market acceptance and underestimate the difficulty, cost and time required to successfully introduce the product and gain any meaningful market share.

What comments do you have about the Australian biotechnology industry?I am constantly impressed with the quality of the science and the number of ideas with huge potential coming out of Australia, especially in the medical technology space.

That said, the capital markets are quite immature and these good ideas often lack the funding and management expertise to fully realise their potential. While seed financing through angels or grants is available, there is a lack of developed infrastructure of venture capital or experienced management teams to bridge the chasm from a good idea to a revenue-generating company ready for the world stage.

The consequence is that many companies get their A-round of financing through the public markets way before they are ready to be public companies. Often the investors – even the management themselves – do not fully appreciate either the time or dollars required to successfully navigate regulatory processes and introduce a new medical technology. The result is often under-funded companies, disillusioned shareholders and lost opportunities.


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R&D Tax Incentives in Australia

The Federal Government provides a tax incentive for companies undertaking research and development (R&D) in order to promote innovation, make eligible companies more internationally competitive and increase business expenditure on R&D.The last time R&D tax incentives were covered in AusBiotech, the Government introduced the International Premium Concession (IPC). The IPC extended tax concessions for companies undertaking R&D activity on behalf of a foreign related party, which were traditionally not able to access the incentive program. In 2009, the Federal Government announced their intention to undertake a wholesale revamp of the R&D Tax Concession program. In September 2009, the Government released a consultation paper outlining proposed changes and possible options for changes to the Tax Concession.

How the tax incentive will changeThe draft legislation for the proposed changes is not scheduled until late in 2009. Any changes will have effect from the first income year after 30 June 2010. What has been confirmed is that the incentive program will change from a tax deduction to a tax credit, with higher incentives provided to a smaller range of R&D activities. Specific changes that have been confirmed by the Government include:

The tax incentive will be a ‘simplified’ tax credit to replace the 125% concession, the 175% incremental premium concession, the IPC and the tax offset for smaller companies.

A 40% tax credit to Australian incorporated companies with a grouped turnover of more than $20m, which can be offset against current and future income tax liabilities.

A 45% refundable tax credit for Australian incorporated companies with a grouped turnover of less than $20m, which can be offset against all tax liabilities.

The location of intellectual property will not be a consideration.

Proposed changes to the tax incentiveThe consultation paper outlines a number of proposed changes which will not be confirmed until after the consultation period and release of draft legislation. As a design principle, the changes will target R&D activity that is in addition to what would have otherwise occurred and provide

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‘spillovers’ - benefits that are shared by other firms and the community.

The proposed changes will increase the value of the tax incentive to companies. The potential benefit under the new program is outlined in table 1. This will however be subject to tighter eligibility requirements, with the first of the proposed key changes to be made to the definition of R&D. Eligible R&D activities are proposed to be defined as systematic, investigative and experimental activities that:

a. involve both innovation and high levels of technical risk, and

b. are for the purpose of producing new knowledge or improvements.

Currently, this is an ‘or’ test, that is, only one of either innovation or high levels of technical risk is required for eligibility. It is through this restriction that the Government hopes to achieve ‘additionality’ and ‘spillovers’, arguing that the absence of either innovation or high levels of technical risk are believed to reduce the likelihood of an activity producing a ‘spillover’ benefit, and reduce what would be in addition to what would otherwise occur.

The other notable proposed change includes the placing of limitations on what can be claimed as supporting, or directly related activities. Directly related activities are currently those which are undertaken for ‘a’ purpose which is directly related to the carrying on of the core R&D. This type of expenditure can be claimed in full under the existing tax incentive.

What does this mean for the biotech sector?The range of R&D activity, which includes the synthesis and/or extraction of therapeutic substances, biological screening and pharmacological testing, pharmaceutical dosage formulation and stability testing, toxicology and safety testing, clinical evaluation, process development and the establishment of the quality, safety and efficacy of the proposed product, is generally considered eligible under the existing R&D tax concession.

It is envisaged that most biotech companies should satisfy the requirement of the innovation and high levels of technical risk test. The exception may be companies that develop generic pharmaceuticals, as the innovation requirement may not be met for the development of chemical compounds which are coming off patent. These can generally be claimed under the existing tax concession provided other eligibility rules are met.


The other point of conjecture is the treatment of supporting or directly related R&D activities. There is a potential risk that these activities may be required to be isolated and treated differently to what is considered core R&D, with limitations imposed as to what supporting activity can be claimed. This is a very uncertain area of the proposed changes. Any potential requirement for the isolation of these activities could act to limit the size of claims, which is counter-intuitive to the objective of the tax incentive program, in addition to increasing the compliance burden (and cost) for all claimants.

If a company can satisfy the new definition of R&D, without being limited by what is seen to be a supporting/directly related activity, then the new R&D tax credit will provide a major boost and increased incentive to the biotech sector. For smaller biotech companies with development stage tax losses, it will provide a welcome 15 cent in the dollar permanent incentive in the form of a refundable rebate from the ATO. For companies with sufficient tax losses the entire

45c credit may be refunded, which may be a very significant cash injection for companies firmly in the cash burn stage.

For larger multinationals, it will provide a boost from the current incentive from 7.5 cents in the dollar to 10 cents plus the normal tax deduction, which could add to significant savings for larger projects with a big dollar spend. Please refer to table 1 for a comparison between current and future benefits of the R&D tax incentive program.

Next StepsThe biotech sector should remain aware of any changes to the R&D tax program, as there is the potential to gain increased R&D benefits from the first income year after 30 June 2010. Businesses should consider the new tax credit if making a on the location of R&D activity, as the new tax credit has the potential to make Australia’s R&D tax incentive more internationally competitive.

For more information on R&D tax incentives please contact:

Sandra Mason Partner

Ph: +61 (2) 8266 0470 Email: [email protected]

Garry Waugh Partner

Ph: +61 (7) 3257 8694Email: [email protected]

Tim Donald Director


Craig Lawn Partner


Existing tax concession New tax credit

Standard 125% claim

175% IPC claim only

$20m group turnover in profit position

$20m group turnover in tax loss position

$20m group turnover

R&D Spend $1m $1m R&D Spend $1m $1m $1m

Deemed incremental R&D expenditure, using the 30 June 2008 income year as an example

NA $200k Tax credit given to offset tax liability

45% 45% 40%

Additional Tax Deduction

$250k $150k Value of tax credit $450k $450k $400k

Value of deduction (net cash benefit) at �0% tax rate

$75k² $45k² Permanent value of tax credit

$150k Up to $450k $100k³

NotesIn some cases it may be possible to claim the 125% concession and the IPC concurrently¹ This assumes a company with an existing presence in Australia claiming the IPC for the first time under transitional provisions² Additional tax deduction multiplied by the 30% tax rate³ Value of refund is value of the credit less the value of a 100% deduction in relation to amounts otherwise deductable

Case Study The table below outlines the cash value of tax incentives under the current tax concession, the current IPC for companies that claimed in the 30 June 2008 year, and the value of the proposed new incentives which apply to all companies. These are split between categories of less than or greater than $20m total group turnover.


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�0 | PricewaterhouseCoopers

PricewaterhouseCoopers LLP1

General funding trends up for quarter,down year over yearVenture capital investment for all sectors, including life sciences, increased in terms of dollars but remainedflat in number of deals during the second quarter of 2009, according to the MoneyTree™ Report fromPricewaterhouseCoopers LLP (PwC) and the National Venture Capital Association based on data fromThomson Reuters.

The $6.9 billion invested during the first half of the year could foreshadow a return to the lowest levels since 1996-97, when the annual totals ranged from$11 billion to $14 billion. These lows preceded the Internet-inspired bubble of 1999-2000, which raised annual investment to an unprecedented and as yet unmatched high of almost $102 billion.

Despite low overall investment during the second quarter of 2009, the life sciences sector1, which includes the biotechnology and medical device industries, sprouted notable green shoots in the venture capital landscape.

“Investments in life sciences companies representedthe highest percentage of total venture capital investments since the inception of the MoneyTreeReport,” noted Tracy Lefteroff, global managing partner of the PwC Venture Capital practice. “And, while the largest deal of the quarter [$146.3 million] was a biotechnology company, even if we exclude it, the biotech sector is still the largest single industry category for the quarter.”

During the venture capital liquidity drought that began in the first quarter of 2008 and extended into 2009, many biotechnology companies closed their doors. After reaching a low point in the first quarter of 2009, the downward slide in venture capital investment showed its first signs of potential reversal in the second quarter—particularly for the life sciences sector.

Life sciences funding declined at a less dramatic 23 percent year over year, compared with 51 percent for all industries. The relative resilience of life sciences funding during the economic downturn affirms the long-term potential of investment opportunities in this sector.

Life sciences funding compared with total funding

Life sciences companies captured 41 percent of all investment dollars and 26 percent of all deals in the second quarter. The share of investment dollars was high compared with historical norms; in 2006-2007, for instance, it was 30 percent. The increase in the sector might be attributed, in part, to a number of large deals completed in the quarter, including four of the top 10, as well as to the sector’s attractive growth potential.

Life sciences funding as a percent of total funding

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Total funding Life Sciences funding

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% Other Sectors% Life Sciences

1 The MoneyTree life sciences sector includes the biotechnology and medical device and equipment industries. Biotechnology is defined as “developers of technology promoting drug development, disease treatment, and a deeper understanding of living organisms; includes human, animal, and industrial biotechnology products and services. Also included are biosensors, biotechnology equipment, and pharmaceuticals.”

Medical devices and equipment industries are defined as those that “manufacture and/or sell medical instruments and devices including medical diagnostic equipment (X-ray, CAT scan, MRI), medical therapeutic devices (drug delivery, surgical instruments, pacemakers, artificial organs), and other health-relatedproducts such as medical monitoring equipment, handicap aids, reading glasses, and contact lenses.”

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Reversing course? 2

Life sciences funding increased for quarter but fell from 2007 and 2008 levelsEven though life sciences captured the largest share of second-quarter funding, the 2009 dollar amount for the sector decreased significantly from 2008 and 2007 levels. Year-to-date 2009 funding amounted to approximately$2.5 billion versus $4.1 billion in 2008 and $4.9 billon in 2007.

Investment in the sector jumped nearly 50 percent,however, during the most recent quarter, rising from approximately $1 billion in the first quarter to approximately $1.5 billion in the second.

Life sciences funding trends

Number of transactions also increased for quarter but decreased from 2007 and 2008

The number of transactions decreased fromapproximately 450 in each of the first halves of 2007 and 2008 to 280 in the first half of 2009. However, deal activity increased slightly from 133 during the first quarter of 2009 to 150 during the second quarter.

Life sciences deal volume

The average transaction size, which had remainedrelatively consistent from the second quarter of 2007 through the fourth quarter of 2008, declined to approximately $7.5 million in the first quarter of 2009. The average transaction size rebounded to $10 million in the second quarter of 2009.

Life sciences average deal size

Recession and credit crisis curbed fundingThe decline in national life sciences funding in recentquarters can be attributed to the global economic recession that accelerated in the third quarter of 2008. As the credit crisis began to ease during the second quarter of 2009, deal activity increased, driven by startup (seed), early-stage, and expansion funding.

Funding for biotech and medical device industries risesDuring the second quarter of 2009, life sciences funding was split between biotechnology at 59 percentand medical devices and equipment at 41 percent.The proportions have generally stayed the same over the past two years, with biotech taking the larger shareat 56 percent to 60 percent.

Life sciences investment split for second quarter 2009

0.0

0.5

1.0

1.5

2.0

2.5

3.0

$ in

bill

ions

Q1 Q2 Q3 Q4

2007 2008 2009

Q1 Q2 Q3 Q40

4

8

12

16

$ in

mill

ions

2007 2008 2009

41% 59% BiotechMedical Devices

0

50

100

150

200

250

Num

ber

of

dea

ls

Q1 Q2 Q3 Q4

2007 2008 2009

�� | PricewaterhouseCoopers


Funding for biotech and medical devices up from first quarter, down from 2008 levelsThe biotechnology industry received the highest level of funding among all industries in the second quarter of 2009, jumping 54 percent over the first quarter with approximately $888 million going into 85 deals. Medical device investments also increased for the quarter, rising 38 percent in terms of dollars and 32 percent in deals, with $628 million going into 75 deals.

The outlook coming out of the second quarter of 2009 was brighter for both industries, which had experienced a significant venture capital decline in recent quarters. Biotech funding decreased during the first quarter of 2009 compared with the same period of 2008 by approximately 17 percent. Funding for medical devices decreased by approximately 32 percent.

Biotech and medical devices funding trends

Biotech-human received the largest amount of biotech funding for the quarterConsistent with historical trends, the biotech-human subsegment received the most biotech venture capital funding at approximately $692 million. In comparison, biotech industrial and equipment received a much lower amount of approximately $84.2 million. Biotech pharmaceuticals, which received $2.5 billion from 2007 through 2008, received only $98 million in the second quarter of 2009. Of that, $75 million was invested in production, with the remainder invested in research.

Biotech funding by subsegment

Medical therapeutics’ second-quarter funding increased by 37 percentConsistent with historical trends, the medical therapeutics subsegment of the medical device industry received the largest share of venture capital funding—approximately$446 million—in the second quarter of 2009, increasingfrom $326 million in the first quarter.

Of the $446 million invested in medical therapeutics, $140 million went for pacemakers and artificial organs,$142 million for surgical equipment, and $68 million for drug delivery equipment.

Medical devices funding by subsegment0.0

0.5

1.0

1.5

2.0

2.5

3.0

$ in

bill

ions

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

Biotechnology Medical Devices and Equipment

$ in

bill

ions

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0.0

0.5

1.0

1.5

2.0

PharmaceuticalBiotech Research

Biotech OtherBiotech Animal and Human Biotech Industrial and Equipment

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

$ in

bill

ions

Med/Health Products Medical TherapeuticsMedical Diagnostics


Feat

ure

artic

les

Reversing course? 4

Geographical distribution follows expected trend

West leads in life sciences funding for quarterGeographical funding trends for the quarter remainedconsistent with the past, with the West—primarilyCalifornia—taking the lead at $742 million (49% of funding). The East, primarily New England, took the next largest share at $444 million (29% of funding). The chart below illustrates the distribution of investment in all four geographic regions.

Funding by geography

Late-stage funding lags, while early-stage risesThe increase in funding from the first to the second quarter of 2009 was driven primarily by increasesin startup (seed) funding, early-stage funding, and expansion. Late-stage funding decreased.

With the improvement over the past few months in the capital markets and a small opening in the initial public offering (IPO) window during the second quarter, venturecapitalists turned their focus to new investments, as the 67 percent increase in second-quarter seed and early-stage funding for all industries suggests. The largesttransaction of the second quarter was a seed-stage deal, which drove a significant percentage of the increase.

Looking at all industries, the decline that began in the first quarter of 2008 in expansion or later-stage venturecapital funding for companies with established productsand growth prospects continued into the second quarter of 2009.

Majority of second-quarter funding for life sciences sector also went to early-stage opportunitiesApproximately 62 percent of funding for the life sciences sector during the second quarter supported early-stage investment, which increased significantly from $418 million during the first quarter to its highest level in threeyears at $940 million. This increase in early-stage funding primarily resulted from the focus on seed funding, which historically has been comparatively insignificant.

Late-stage expansion funding has been declining since the third quarter of 2008, from $1.7 billion, to the second quarter of 2009, at $576 million. Historically,late-stage attracted most of the funding in biotechnology and medical devices. However, the trend has recentlybegun to shift, with early-stage funding increasing at the expense of late-stage.

This shift indicates that investors see significant growthopportunity in the sector over the next five to 10 years. They are choosing to place more money in seed, start-up, and early-stage products to take advantage of that opportunity.

Life sciences funding by stage

Early-stage funding drives investments in biotechIn biotech, early-stage funding tripled from first-quarter levels to $649 million during the second quarter of 2009. Biotech drugs, pharmaceutical research, biotech research, and pharmaceutical production drove growthin early-stage funding.

0%

20%

40%

60%

80%

100%

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

East South Midwest West

$ in

bill

ions

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q20.0

0.6

1.2

1.8

2.4

3.0

Later StageEarly Stage



Seed funding has played an increasing role in early-stage biotech funding, steadily rising from $45 million in the first quarter of 2007 to $154 million in the thirdquarter of 2008. A decline to $84 million in the first quarter of 2009 reversed to $188 million in the second quarter. Approximately 81 percent of early-stage biotech funding in the second quarter of 2009 went to biotech-human drug development and biotech equipment.

The second-quarter increase in early-stage funding was offset by a decrease in late-stage funding, from$361 million in the first quarter to $240 million in the second quarter. Late-stage funding suffered fromdeclining expansion-stage funding, which droppedfrom an average quarterly funding of $300 to $500 million during 2007 and 2008 to $57 million and $83 million in the first two quarters of 2009.

Biotech funding by stage

Biologics and personalized medicine continue to attract investmentSignificant investments in the quarter included:

• $216 million in medical diagnostics biotechnology (personalized medicine)

• $135 million in therapeutics• $75 million for protein therapeutics• $46 million for immune response drugs• $43 million related to monoclonal antibodies

(biologics or mAbs)

Early-stage funding remains strong in medical devicesFollowing a trend similar to biotech, early-stage funding ofmedical devices moved upward, from $171 million in the first quarter of 2007 to $292 million in the second quarter of 2009.

Medical device funding by stage

Approximately 78 percent of early-stage funding in the medical device industry in the second quarter specifically targeted medical therapeutics equipment. Investments in this subsegment included:

• $109 million relating to surgical equipment• $62 million in drug delivery equipment• $38 million for other therapeutic equipment,

including defibrillators

Pacemakers and artificial organs lead late-stage fundingOf medical device late-stage funding, 75 percent was invested in medical therapeutics and the remainder in medical health products. Significant investments in the medical therapeutics subsegment included:

• $121 million relating to pacemakers and artificial organs

• $52 million for surgical lasers• $32 million for surgical instrumentation equipment

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0.00.20.40.60.81.01.21.41.61.8

$ in

bill

ions


2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0.0

0.4

0.8

1.2

$ in

bill

ions



Feat

ure

artic

les

Reversing course? 6

Investment in the medical health products subsegment was primarily attributable to health-related optics, including glasses and lenses:

• $47 million for health-related optics• $10 million for medical monitoring equipment• $8 million for disposable medical products

Follow-on investments favored over first-time fundingDuring the economic downturn, venture capitalists chose to take additional positions in existing investees rather than supporting new companies. For the life sciences sector, follow-on investment transactions as a percentage of total venture capital investment activity increased from 73 percent for 2007 and 2008 to 83 percent for the second quarter of 2009.

The number of first-time deals was the lowest since 1994. While the number of first-time deals declined by 5 percent, the level of funding went up by 9 percent.The average first-time deal across all industries was $4.8 million in the second quarter, compared to $4.2 million during the first quarter. Biotechnology,medical device, and software industries received the highest levels of first-time dollars for the quarter.

Deal volume of follow-on vs. initial investments

Follow-on investments for the sector amounted to approximately $1.2 billion, compared with $270 million for initial investments. The dollar amount invested in follow-on deals, as a percentage of total investments, has stayed consistent for life sciences.

Dollars invested in follow-on vs. initial investments

Venture capital funding remains low,but outlook brightens for life sciences

Though the second-quarter 2009 MoneyTree data portends a brighter outlook for investment in the life sciences sector, the overall venture capital forecastremains dim. The National Venture Capital Association (NVCA) recently reported that just 25 venture capital fundsraised money in the second quarter, based on Thomson Reuters data. The NVCA noted that this level representsthe smallest number of venture funds raising money in a single quarter since the third quarter of 1996 (21 funds) and the lowest amount, $1.7 billion, committed since the first quarter of 2003, when $938.1 million was raised.2

“Many venture firms are waiting until 2010 and beyond to go out to their limited partners who, in an improvedmarket, will look more favorably upon the asset class vis-a-vis other alternatives,” Mark Heesen, president of the association, commented. “That said, there will be firms that will not be able to raise a follow-on fund, and our industry is positioned to contract over the next five years through this type of attrition.”3

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

0%10%20%30%40%50%60%

58 72 58 67 67 67 46 44 31 27

152 165 141 173 167 164 170 151 112 133

70%80%90%

100%

2009

Q2

Initial investmentFollow-on investment

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0%10%20%30%40%50%60%70%80%90%

100%463 374 414 451 449 424 287 245 153 270

2,220 1,837 1,512 1,847 1,631 1,554 1,877 1,388 877 1,247


2 Thomson Reuters and National Venture Capital Association News Release, “Venture Capital Fundraising Activity Contracts in the Second Quarter of 2009,” July 13, 2009.

3 Ibid.

Reversing course? 6

Investment in the medical health products subsegment was primarily attributable to health-related optics, including glasses and lenses:

• $47 million for health-related optics• $10 million for medical monitoring equipment• $8 million for disposable medical products

Follow-on investments favored over first-time fundingDuring the economic downturn, venture capitalists chose to take additional positions in existing investees rather than supporting new companies. For the life sciences sector, follow-on investment transactions as a percentage of total venture capital investment activity increased from 73 percent for 2007 and 2008 to 83 percent for the second quarter of 2009.

The number of first-time deals was the lowest since 1994. While the number of first-time deals declined by 5 percent, the level of funding went up by 9 percent.The average first-time deal across all industries was $4.8 million in the second quarter, compared to $4.2 million during the first quarter. Biotechnology,medical device, and software industries received the highest levels of first-time dollars for the quarter.

Deal volume of follow-on vs. initial investments

Follow-on investments for the sector amounted to approximately $1.2 billion, compared with $270 million for initial investments. The dollar amount invested in follow-on deals, as a percentage of total investments, has stayed consistent for life sciences.

Dollars invested in follow-on vs. initial investments

Venture capital funding remains low,but outlook brightens for life sciences

Though the second-quarter 2009 MoneyTree data portends a brighter outlook for investment in the life sciences sector, the overall venture capital forecastremains dim. The National Venture Capital Association (NVCA) recently reported that just 25 venture capital fundsraised money in the second quarter, based on Thomson Reuters data. The NVCA noted that this level representsthe smallest number of venture funds raising money in a single quarter since the third quarter of 1996 (21 funds) and the lowest amount, $1.7 billion, committed since the first quarter of 2003, when $938.1 million was raised.2

“Many venture firms are waiting until 2010 and beyond to go out to their limited partners who, in an improvedmarket, will look more favorably upon the asset class vis-a-vis other alternatives,” Mark Heesen, president of the association, commented. “That said, there will be firms that will not be able to raise a follow-on fund, and our industry is positioned to contract over the next five years through this type of attrition.”3

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

0%10%20%30%40%50%60%

58 72 58 67 67 67 46 44 31 27

152 165 141 173 167 164 170 151 112 133

70%80%90%

100%

2009

Q2


2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

0%10%20%30%40%50%60%70%80%90%

100%463 374 414 451 449 424 287 245 153 270

2,220 1,837 1,512 1,847 1,631 1,554 1,877 1,388 877 1,247


2 Thomson Reuters and National Venture Capital Association News Release, “Venture Capital Fundraising Activity Contracts in the Second Quarter of 2009,” July 13, 2009.

3 Ibid.


During the second quarter of 2009, five IPOs broughtto market, valued at $720.7 million, marked some improvement in exit activity. That was the highest number since the first quarter of 2008 and the highest volume since the first quarter of 2007, but still fell short of historical norms. The quarter’s 59 M&A exits totaling $2.6 billion tracked the two prior quarters but roseconsiderably higher in average disclosed value. Of those 59 exits, seven deals totaling $1.4 billion were in the life sciences sector.4

“The fact that several venture-backed companies successfully entered the public markets and performed well is encouraging,” said Heesen. “However, we remainconcerned about the extremely thin pipeline of companiesin registration as it indicates that it will be some time before we can even be in a position to return to healthy IPO activity levels.”5

Despite the still-depressed level of venture capital activity,the life sciences sector seems well-positioned to attract a large share of funding from venture capital and other sources. Further economic recovery should create a positive environment for life sciences innovation and investment over the next few quarters, assuming federal stimulus money boosts local spending and employment as intended and the credit markets continue to loosen.

The stimulus package allocated $10.4 billion for the National Institutes of Health—with the largest part going to scientific research—and $1.1 billion for research to compare the effectiveness of alternative treatments for diseases. An additional $19 billion was designated to help advance the adoption of electronic health records (EHRs). Widespread use of EHRs would create a bioinformatics infrastructure that could reduce the costs of clinical trials and benefit scientific research.

The package also removed restrictions on stem cell research, which should help attract more capital for biotech companies ready to forge ahead in early- and late-stage investigations in this field.

With government support and increased investor confidence, the third quarter could see additional upward movement in funding for the sector. While life sciences companies have endured unprecedentedeconomic turmoil during the past several quarters, the second quarter 2009 might have marked a turning point in their funding outlook.

About PricewaterhouseCoopers’ Pharmaceutical and Life Sciences Industry GroupPricewaterhouseCoopers’ global Pharmaceutical and Life Sciences Industry Group (www.pwc.com/pharma) is dedicated to delivering effective solutions to the complex strategic, operational, and financial challenges facing pharmaceutical and life sciences companies. We provideindustry-focused assurance, tax, and advisory services to build public trust and enhance value for our clients and their stakeholders. We draw on the knowledge and skills of more than 155,000 people in 153 countries fromacross our network to share their thinking, experience, and solutions to develop fresh perspectives and practical advice.

ContactsTracy Lefteroff, Partner+1 (408) [email protected]

Attila Karacsony, Director+1 (973) [email protected]

www.pwc.com/pharma

This document is for general information purposes only and should not be used as a substitute for consultation with professional advisers.

© 2009 PricewaterhouseCoopers LLP. All rights reserved. “PricewaterhouseCoopers” refers to PricewaterhouseCoopers LLP (a Delaware limited liability partnership) or, as the context requires, the PricewaterhouseCoopers global network or other member firms of the network, each of which is a separate and independent legal entity. *connectedthinking is a trademark of PricewaterhouseCoopers LLP (US). NY-10-0113

4 Thomson Reuters and National Venture Capital Association News Release, “Venture-Backed Exit Market Shows Signs of Life for the First Time Since First Quarter 2008,” July 1, 2009.

5 Ibid.


Feat

ure

artic

les


Market performance

Mar

ket

per

form

ance


Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices

ASX All Ordinaries Life Sciences Life Sciences ex majorsNASDAQ Composite NASDAQ Biotech

-20%

-10%

0%

10%

20%

30%

40%

30-Jun 3-Jul 10-Jul 17-Jul 24-Jul 31-Jul 7-Aug 14-Aug 21-Aug 28-Aug 4-Sep 11-Sep 18-Sep 25-Sep 30-Sep

Table 1: Quarterly movements of the Australian life sciences sector compared to major indices

Figure 2: Two-year comparison of the Australian life sciences sector by market cap compared to major indices

Performance overview

ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

30-Sep-07 30-Dec-07 30-Mar-08 30-Jun-08 30-Sep-08 30-Dec-08 30-Mar-09 30-Jun-09 30-Sep-09

Index Value

30-Jun-09 30-Sep-09 % Change

ASX All Ordinaries (Index) 3,948 4,739 20.0%

NASDAQ Composite (Index) 1,835 2,122 15.7%

NASDAQ Biotech (Index) 750 840 12.0%

Life Sciences (Market Cap A$m)

31,012 33,541 8.2%

Life Sciences ex majors (Market Cap A$m)

4,464 5,856 31.1% ASX All Ordinaries

(Index)

NASDAQComposite

(Index)

NASDAQBiotech(Index)

Life Sciences(Market Cap

A$m)

Life Sciences ex majors

(Market Cap A$m)

31.1%

8.2%

20.0%

12.0%

15.7%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

Table 2: Yearly movements of the Australian life sciences sector by market capitalisation compared to major indices

Index Value

30-Sep-08 30-Sep-09 % Change

ASX All Ordinaries (Index) 4,631 4,739 2.3%

NASDAQ Composite (Index) 2,082 2,122 1.9%

NASDAQ Biotech (Index) 836 840 0.4%

Life Sciences (Market Cap A$m)

34,020 33,541 -1.4%

Life Sciences ex majors (Market Cap A$m)

4,165 5,856 40.6%

2.3% 1.9% 0.4%

-1.4%

40.6%

-5.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

ASX All Ordinaries

(Index)

NASDAQComposite

(Index)

NASDAQBiotech

Life Sciences(Market Cap A$m)

Life Sciences exmajors (Market

Cap A$m)


Table 3: Quarterly summary of the Australian life sciences sector’s performance

MCap (A$m)

% of total value

Companies with share price gains

Proportion of subsector up

Companies with share

price lossesProportion of

subsector down

Companies with share price flat

Proportion of subsector flat

Total number of companies

Pharma/Biotech 24,426 73% 56 79% 11 15% 4 6% 71

Pharma/Biotech ex CSL 4,415 75% 55 79% 11 16% 4 6% 70

Med Device 9,114 27% 31 67% 12 26% 3 7% 46

Med Device ex COH, RMD 1,441 25% 30 68% 12 27% 2 5% 44

Life Sciences 33,541 100% 87 74% 23 20% 7 6% 117

Life Sciences ex majors 5,856 100% 85 75% 23 20% 6 5% 114

Figure 3: Quarterly performance of the Australian life sciences sector and subsectors

Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD

-20%

-10%

0%

10%

20%

30%

40%

30-Jun 3-Jul 10-Jul 17-Jul 24-Jul 31-Jul 7-Aug 14-Aug 21-Aug 28-Aug 4-Sep 11-Sep 18-Sep 25-Sep 30-Sep

Index Market capitalisation (A$m)

30-Jun-09 30-Sep-09 % Change

Pharma/Biotech 22,816 24,426 7.1%

Pharma/Biotech ex CSL 3,414 4,415 29.3%

Med Device 8,196 9,114 11.2%

Med Device ex COH, RMD 1,051 1,441 37.1%

Life Sciences 31,012 33,541 8.2%

Life Sciences ex majors 4,464 5,856 31.2%

31.2%

11.2%

7.1%8.2%

29.3%

37.1%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

Pharma/Biotech

Pharma/Biotechex CSL

MedDevice

Med Device ex COH,

RMD

LifeSciences

Life Sciences ex majors

Table 4: Quarterly movements of the Australian life sciences sectors

Figure 4: Two-year comparison of the Australian life sciences sector’s performance by market cap

Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD

-80%

-60%

-40%

-20%

0%

20%

30-Sep-07 30-Dec-07 30-Mar-08 30-Jun-08 30-Sep-08 30-Dec-08 30-Mar-09 30-Jun-09 30-Sep-09

Mar

ket

per

form

ance


Quarterly financing

Figures 5 and 6: Quarterly comparison of IPOs in Australia and the US

Australia

Biotech Medical Devices

0 0

0

0

5

10

15

20

25

30

Q1FY09 Q2FY09 Q3FY09 Q4FY09 Q1FY10

Cap

ital

Rai

sed

(A$

m)

0 0

24

US


0

1,215

00

0 60

200

400

600

800

1000

1200

1400


Cap

ital

Rai

sed

(A$

m)

Med Device: $6m

0

Table 5: Number of Australian IPO listings

Biotech Med Devices ASX total

Q1FY10 0 0 3

Q4FY09 0 0 0

Q3FY09 0 0 3

Q2FY09 1 0 5

Q1FY09 0 0 16

Table 6: Number of US IPO listings

Biotech Med Devices

Q1FY10 2 0

Q4FY09 0 1

Q3FY09 0 0

Q2FY09 0 0

Q1FY09 0 0

Table 7: Total of quarterly Australian IPO listings

Company Issue Price MCap ($m)

Nil - -

Total - -

Table 8: Total of quarterly US IPO listings

Company Capital raised (A$)

Talecris Biotherapeutics Hldg 1,115.2

Cumberland Pharmaceuticals Inc 99.8

Total �,��.�

Figures 7 and 8: Quarterly comparison of secondary financing in Australia and the US

Australia


6

34

113

6

5

16

1928

67

44

101

50

100

150

200

250


Cap

ital

Rai

sed

(A$

m)

Biotech: $6mMed Device: $6m

0

1,928

US


647

1,2761,794

540

65

47

67

1,235

172

795

500

0

1,000

1,500

2,000

2,500

3,000


Cap

ital

Rai

sed

(A$

m)

Table 9: Number of Australian secondary raisings

Biotech

Avg. amount raised (A$m)

Med Devices

Avg. amount raised (A$m)

Q1FY10 30 2.2 11 9.2

Q4FY09 21 5.4 9 1.8

Q3FY09 22 1.5 4 1.3

Q2FY09 15 0.4 9 0.7

Q1FY09 29 66.5 19 2.3

Table 10: Number of US secondary raisings

Biotech Med Devices

Q1FY10 40 17

Q4FY09 7 3

Q3FY09 15 7

Q2FY09 8 4

Q1FY09 18 10

IPO market

Amount shown is total market cap addition to the LS Index from IPOs on first day of trading

Secondary finance market


Yearly financing

Figures 9 and 10: Annual comparison of IPOs in Australia and the US

Australia

22

176118

24

63

153

105

0

0

50

100

150

200

250

300

350

FY06 FY07 FY08 FY09 FY10 - YTD

Cap

ital

Rai

sed

(A

$m

)


US

1,636

6

5174,277

325588

1,013

0

1,000

2,000

3,000

4,000

5,000

6,000

FY06 FY07 FY08 FY09 FY10-YTD

Cap

ital

Rai

sed

(A$

m)


1,215

Table 11: Number of Australian IPO listings

Biotech Med Devices ASX total

FY10 - YTD 0 0 3

FY09 1 0 24

FY08 4 3 79

FY07 6 7 245

FY06 3 8 172

Table 12: Number of US IPO listings

Biotech Med Devices

FY10 - YTD 2 0

FY09 0 1

FY08 8 8

FY07 42 12

FY06 20 8

Secondary finance market

Figures 11 and 12: Annual comparison of secondary finance in Australia and the US

Australia

297 438 274

236229

2,081

71

42

0

500

1,000

1,500

2,000

2,500

FY06 FY07 FY08 FY09 FY10-YTD

Cap

ital

Rai

sed

(A

$m

)


67

101

US


3,330

8,603

15,810 16,766

719

1,699

5,542 6,202

0

5,000

10,000

15,000

20,000

25,000

FY05 FY06 FY07 FY08 FY09

Cap

ital

Rai

sed

(A$

m)

1,794

795

Table 13: Number of Australian secondary raisings

Biotech Med Devices

FY10 - YTD 30 11

FY09 87 41

FY08 99 66

FY07 98 75

FY06 56 28

Table 14: Number of US secondary raisings

Biotech Med Devices

FY10 - YTD 40 17

FY09 48 24

FY08 80 29

FY07 258 59

FY06 257 123

IPO market

* Amount shown is total market cap addition to the LS Index from IPOs based on first day of trading


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AVH

NSP

BTA

BPH

GBI

GBI

UNI

RBY

HCT

PRR

0% 500% 1000% 1500% 2000% 2500% 3000%

HTX

� PRIMA BIOMED LTD (PRR)Return: 2400%Closing Price: $0.175MCap: A$90.56m

During the period the FDA approved a phase II clinical trial of the vaccination CVac. A subsidiary of Prima BioMed received a patent for Cripto-1 from the Republic of South Korea’s Patent Office.

�HOLISTA COLLTECH LIMITED (HCT)Return: 933%Closing Price: $0.16MCap: A$17.50m

Following the completion of the acquisition of Holista during the period, the company has voted to change its name to Holista Colltech Limited.

C.H. (Mick) Aw was appointed to the board. The company was appointed Asia Pacific’s exclusive distributor for a mosquito larvacide by EntoGenex LLC.

�ROCKEBY BIOMED LIMITED (RBY)Return: 675%Closing Price: $0.031MCap: A$2.32m

The company released its preliminary final report, stating that group sales increased more than 2.5 times compared to sales in FY08.

The company announced its intention to delist to become an unlisted public company subject to shareholder and ASX approval.

� UNILIFE MEDICAL SOLUTIONS LIMITED (UNI)Return: 376%Closing Price: $1.38MCap: A$305.50m

In the period, Unilife commenced syringe production in the US, having received approval in the US, Canada and Europe. The company entered into a $30m industrialisation agreement with Sanofi-Aventis.

Merger agreement was entered into to re-domicile Unilife group in the US.

�GENERA BIOSYSTEMS LIMITED (GBI)Return: 344%Closing Price: $0.8MCap: A$47.00m

The company received positive results for its large scale trial of the PapType human papilloma virus diagnostic.

� BIOPHARMICA LIMITED (BPH)Return: 305%Closing Price: $0.15MCap: A$11.24m

The company’s investee announced positive results from its European trials of its anaesthetic BAR analysis method.

The drug HLS5, a tumour suppressor factor, has been issued with a US patent.

BioPharmica has been offered an exclusive option to invest in Advent Energy.

� BIOTA HOLDINGS LIMITED (BTA)Return: 299%Closing Price: $2.73MCap: A$477.6m

A phase I trial of the drug BTA9881, a respiratory synctial virus treatment, was completed.

Phase III clinical trials of CS-8958, an influenza treatment, showed positive results, meeting the primary and secondary endpoints.

�NUSEP LIMITED (NSP)Return: 240% Closing Price: $0.17 MCap: A$2.82m

As part of the recent share purchase offer, the company raised a total of $3.75m.

William Spee was appointed to the board.

�AVITA MEDICAL LTD (AVH)Return: 183%Closing Price: $0.17MCap: A$17.07m

The company received regulatory approval for ReCell from the Chinese Food and Drug Administration and received its first milestone payment as part of an agreement with the US Defense Department.

�0HEALTHLINX LIMITED (HTX)Return: 110%Closing Price: $0.088MCap: A$9.53m

During the quarter the company’s OvPlex test received the CE mark of approval while the company secured Queensland’s Mater Health Services as a collaborator for its second study for OvPlex.

Top 10 performers over the past four quarters

Note: The company announcements referred to above were made in the latest quarter and were sourced from the Australian Securities Exchange website, www.asx.com.au


Mar

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�FERMISCAN HOLDINGS LIMITED (FER)Return: -78%

Closing Price: $0.067MCap: A$9.61m

The company announced the resignation of David Young, managing director, and Greg West, CFO and company secretary. Ian Chalmers and Mark Fordree were appointed to the board, replacing Gary Gorton and Leon Carr. During the period, discussions with institutional and professional investors did not produce the required funding being sought.

EMS

SHC

NDL

SLT

XCD

SLA

STI

IAT

ICV

FER

-90% -80% -70% -60% -50% -40% -30% -20% -10% 0%

�INCITIVE LIMITED (ICV)Return: -70%Closing Price: $0.009MCap: A$2.88m

The company experienced a net loss for FY09 of $1.25m – down by 25% on the prior financial year.

�IATIA LIMITED (IAT)Return: -65%Closing Price: $0.014MCap: A$3.45m

During the period the company reported an expected loss of between $900k and $1.1m for FY09.

�STIRLING PRODUCTS LIMITED (STI)Return: -64%Closing Price: $0.009MCap: A$6.32m

The company appointed Neil Covey to replace George Karantzias as a non-executive director, signed a heads of agreement to acquire the rights to commercialise a patented new class of aerosol devices and signed a letter of intent with an undisclosed Brazilian distribution partner. Also clinical study results showed a high cure rate of TB patients co-infected with HIV.

�SOLAGRAN LIMITED (SLA)Return: -61%Closing Price: $1.55MCap: A$43.86m

In the period the company’s drug Bioeffective A received regulatory approval in Malaysia.Robert Payne resigned as non-executive director and was replaced as company secretary by Justyn Stedwell. Andi Solaiman was appointed as a non-executive director.

�XCEED CAPITAL LTD (XCD)Return: -60%Closing Price: $0.026MCap: A$2.60m

During the quarter, Boron Molecular, a 100% owned company reported a final operating profit for FY09 of $959k. The consolidated entity, Xceed Capital, made a full year loss of $2.138m.

�SELECT VACCINES LIMITED (SLT)Return: -56%Closing Price: $0.004MCap: A$1.02m

During the period Robin Beaumont resigned as a director and of the company and was replaced as chairman by Shane Allan.

�NEURODISCOVERY LIMITED (NDL) Return: -54%Closing Price: $0.041MCap: A$25.24m

During the period a specialist services agreement was entered into between an international pharmaceutical company and NeuroDiscovery’s subsidiary, NeuroSolutions.

John Hannaford resigned from the board and Dr Chris Moyses has resigned as CEO and as a director of the company.

�SUNSHINE HEART (SHC)Return: -53%Closing Price: $0.047MCap: A$2.61m

In the quarter it was reported that the first patients fitted with the company’s device, C-Pulse, successfully completed their follow-up evaluation. BioSignal raised $120k through a placement.

�0EASTLAND MEDICAL SYSTEMS LTD (EMS)Return: -52%Closing Price: $0.065MCap: A$22.86m

Trevor Strahan tendered his resignation as company secretary in the period and was replaced by Dermott Patterson. Peter Tiede also resigned as CFO.

Note: The company announcements referred to above were made in the latest quarter and were sourced from the Australian Securities Exchange website, www.asx.com.au

Bottom 10 performers over the past four quarters


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Announcements – Australia

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Partnerships

Company Pharma/biotech partner Application Value Comments

Biotechnology Total 25

Acrux (ACR) Hanwha Group Ellavie Not disclosed Marketing and distribution agreement for transdermal spray product Ellavie in South Korea.

Acrux (ACR) HRA Pharma Menopause symptoms A$2m Marketing and distribution agreement for Acrux’s product in the European pharmaceutical markets.

Acuvax (ACU) National Institute of Allergy and Infectious Disease

Vaccine for tick-borne encephalitis

A$2.9m Acuvax subsidiary Hawaii Biotech has won a cash grant from the Institute for its vaccine technology.

Anteo Diagnostics (ADO) DioSion Diagnostics Antibody based diagnostic tests

Not disclosed Anteo has signed a non-exclusive co-operation and licence agreement with Malaysian company DioSion.

Arana Therapeutics (AAH) Xoma Technology application Not disclosed Arana has cut an in-licensing deal with US-based company Xoma covering a suite of technologies.

Avita Medical (AVH) US Department of Defense Spray-on skin A$0.5m Avita has received its first milestone payment as part of an agreement with the US Defense Department.

Benitec (BLT) Biomics Biotechnologies RNAi Not disclosed Collaboration to use vector expressed RNAi to develop a treatment for chronic hepatitis B virus infection.

Benitec (BLT) Biomics Biotechnologies Chronic hepatitis B virus (HBV) infection

Not disclosed Binding agreement to collaborate on a DNA directed or vector expressed RNAi.

BioDiem (BDM) PATH, The Institute of Experimental Medicine

Influenza A$3.6m The Institute of Experimental Medicine has executed an agreement to develop BioDiem’s LAIV technology for use in developing countries.

Bionomics (BNO) Start-up Australia Ventures Cancer and diseases of the central nervous system

A$7m The company has satisfied one of the two outstanding conditions of its subscription agreement.

BioPharmica (BPH) University of Western Australia

Anti-cancer therapies Not disclosed Intellectual property agreement to research and develop anti-cancer therapies.

Circadian Technologies (CIR)

PerkinElmer Not disclosed Not disclosed Circadian’s wholly owned subsidiary, Vegenics, has entered into an agreement with PerkinElmer.

Coltech Australia (CAU) EntoGenexLLC Mosquitod Larvarcide Not disclosed Appointed Asia Pacifica’s exclusive distributor by EntoGenex

HealthLinx (HTX) Meter Health Services OvPlex Not disclosed HealthLinx has secured Queensland’s Mater Health Services as a collaborator for its second study for OvPlex.

Hexima (HXL) Pioneer Hi-Bred Disease resistance in plants

Not disclosed Non-exclusive research licensing agreement for the evaluation of Hexima’s Multi-Gene technology.

NeuroDiscovery (NDL) Undisclosed Proprietary compound evaluation

A$0.6m Specialist services agreement between an international pharmaceutical company and NeuroDiscovery’s subsidiary NeuroSolutions.

Novogen (NRT) Marshall Edwards Cancer cell death US$1.5m The two companies have concluded a licence agreement to develop and license the drug.

Phosphagenics (POH) Metier Tribeca Cosmetic products Not disclosed Agreement to launch a line of premier cosmetic products using Phosphagenics technology.

Phosphagenics (POH) Metabolic Pharmaceuticals Not disclosed Not disclosed Phosphagenics has signed a collaborative research and option agreement with Metabolic Pharmaceuticals.

Phylogica (PYC) Viaticus Capital International investor relation services

Not disclosed The company has appointed Viaticus to provide international investor relation services.

Progen (PGL) TransBiotech Liver cancer A$5m Progen has formalised the out-license of liver cancer drug PI-88 to TransBiotech.

QRxPharma (QRX) Liaoning Nuokang Medicines Haemostasis US$5m Strategic alliance with Liaoning Nuokang Medicines to develop and commercialise QRxPharma’s venomics assets for the Chinese market.

SciGen (SIE) Bayer Schering Pharma AG Insulin franchise Not disclosed Supply and distribution agreement to expand the insulin franchise through alliance with blue-chip pharma companies.

Stirling Products (STI) Sheiman Ultrasonic Research Foundation

Aerosol generation devices

Not disclosed Heads of agreement to acquire the rights to and commercialise a patented new class of aerosol devices.

Stirling Products (STI) Undisclosed Botanical products Not disclosed Stirling has signed a letter of intent with an undisclosed Brazilian distribution partner.

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Company Pharma/biotech partner Application Value Comments

Medical Devices Total 21

Austofix Group (AYX) Undisclosed Orthopaedic implants Not disclosed Agreement to distribute the implants in Turkey.

Austofix Group (AYX) Undisclosed Orthopaedic implants Not disclosed Contract to supply an Australian public hospital with a wide range of implants.

Austofix Group (AYX) Silvamed Hip and wrist fracture treatment

Not disclosed The company has signed an agreement to appoint Silvamed as its South African distributor.

CathRx (CXD) Subito Cardiology Cardiac arrhythmias Not disclosed Agreement to distribute CathRx products across Scandinavia, Central Eastern Europe and the Baltic States.

CathRx (CXD) Merce V Electromedicina Cardiac arrhythmias Not disclosed Agreement to distribute CathRx products to hospitals across Spain.

CathRx (CXD) Setfarma Catheter products Not disclosed Distribution agreement to provide Cathrx products to hospitals in Portugal.

Cochlear (COH) Otologics Otologics technology US$25m Exclusive licensing agreement to purchase patent rights and joint development activities.

Compumedics (CMP) Undisclosed Sleep-diagnostics devices

A$325k Compumedics has won a sleep-diagnostics devices contract with an undisclosed partner.

Cyclopharm (CYC) Alfred Health Solutions Medical imaging services

Not disclosed Joint venture agreement to provide medical imaging services to Macquarie University Hospital.

Karmelsonix (KSX) Medi-Point Wheezometer and WHolter devices

US$1.4m Territorial agreement to distribute the devices in Seoul, Korea.

Karmelsonix (KSX) Newmedics PulmoTrack system Not disclosed Distribution agreements to market the system in Germany and Romania.

Medivac (MDV) Kimberley-Clark Australia Wipe products Not disclosed Partnership involving Medivac subsidiary Sunnywipes to test market its products.

MediVac (MDV) Relia Trading Waste management system for hospitals and quarantine facilities

Not disclosed Distribution agreement to sell, market and service the company’s product in Greece and Cyprus.

MediVac (MDV) Ozonator Industries Sterilisation and sanitation of biohazardous waste

Not disclosed Letter of intent for the exclusive distribution of the Ozonator in Australia and New Zealand.

Norwood Abbey (NAL) Massachusetts Institute of Technology

Harm minimisation Norwood to receive 25% of future net revenues

Licensing agreement over all NAL patents and intellectual property flowing from the Needle-Free project.

Occupational & Medical Innovations (OMI)

Undisclosed Auto-retractable safety syringe

Not disclosed A letter of intent has been signed to execute a distribution agreement to market the device.

Optiscan Imaging (OIL) Carl Zeiss Neurosurgery Not disclosed Optiscan has decided to continue the collaboration agreement which has existed since 2007.

Optiscan Imaging (OIL) Hoya Intellectual, manufacturing and service rights for gastroenterology technology

US$575k Optiscan has signed three agreements with Hoya governing future access to Hoya’s technology.

SafetyMed (SFP) Exelint International Syringes and needles Not disclosed SafetyMed has terminated a strategic alliance agreement with Exelint.

SafetyMed (SFP) Dispomedicor Syringes and needles A$25m SafetyMed has signed a letter of intent with Hungarian medical products manufacturer Dispomedicor.

Unilife Medical Solutions (UNI)

Sanofi-Aventis Ready-to-Fill syringe A$30m Industrialisation agreement to commercialise the device.


Dominant company Target company Type of deal Value Comments


BioPharmica (BPH) Advent Energy Acquisition Not disclosed BioPharmica has been offered an exclusive option to invest in Advent Energy.

BioProspect (BPO) Re-Gen Wellness Products

Acquisition Not disclosed Acquisition of Melbourne based Re-Gen, a specialist provider of skin care.

Biosignal (BOS) Commonwealth Biotechnologies

Divestment US$2.6m BOS has signed documents for the sale of biofilm intellectual property.

Biosignal (BOS) RGM Entertainment Acquisition A$5.1m Biosignal has entered into a heads of agreement to purchase the assets of RGM Entertainment and its associated companies.

Colltech Australia (CAU) Holista Biotech Acquisition Not disclosed The acquisition of Holista has been completed.

HalcyGen Pharmaceuticals (HGN)

Mayne Pharma International

Acquisition US$15m plus an earnings share agreement

Definitive agreement to acquire Mayne from Hospira Australia.

Immuron (IMC) Hadasit Medical Research Services & Development

Acquisition Not disclosed Immuron has completed the acquisition of intellectual property.

Peplin (PLI) LEO Pharma Merger Not disclosed Peplin has entered into a definitive merger agreement.


Avastra Sleep Centres (AVS) Not applicable Divestment US$5.9m Avastra has sold US subsidiaries somniTech and somniCare after going into voluntary administration.

Avastra Sleep Centres (AVS) Graymark Healthcare Divestment US$2.5m The company has sold its indirect subsidiary, Avastra Eastern Sleep Centres, to Graymark Healthcare.

Cordlife (CBB) Australian Stem Cell Healthcare

Acquisition Not disclosed A private investment company has acquired a 50% shareholding in Cordlife subsidiary Australian Stem Cell Healthcare from CellSense.

CordLife (CBB) Kalbe Farma Acquisition Not disclosed CordLife has increased its stake in PT Cordlife through a share acquisition from Kalbe Farma.

Heartware (HIN) Thoratec Acquisition Not disclosed Joint termination of the proposed merger due to the US Federal Trade Commission’s opposition.

Norwood Abbey (NAL) Sino-Excel Acquisition A$90m Norwood has entered into a binding letter of intent to acquire a 100% interest in Sino-Excel.

Safety Medical Products (SFP)

Not disclosed Divestment A$1.3m Wholly owned SFP subsidiary Bagot Press has sold its business to an undisclosed investor.

Unilife Medical Solutions (UNI)

Unilife Corporation Merger Not disclosed Merger agreement to re-domicile Unilife group in the US.

Mergers, acquisitions and divestments

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Clinical trials

Company Drug Application Comments

Pre-Clinical Total 10

Antisense Therapeutics (ANP) ATL1101 Prostate cancer Pre-clinical studies have shown the treatment suppressed the growth of prostate tumours.

BioPharmica (BPH) Undisclosed anti-mitotic drug Anti-cancer activity The drug has been developed for pre-clinical testing of anti-cancer activity.

Fermiscan Holdings (FER) Hair sample test Breast cancer diagnosis A pre-commercialisation test of the device is under way in Sydney.

Imugene (IMU) H1N1 AND H3N2 influenza vaccinations

Swine influenza Laboratory work has been completed and the company is awaiting approval for animal trials.

Mesoblast (MSB) Allogeneic or off-the-shelf adult stem cells

Disc repair The pre-clinical disc repair trial has been featured at the World Congress on Osteoarthritis.

OBJ Limited (OBJ) eM-Patch Tooth whitening agent A collaborative study between OBJ and Curtin University has shown positive results.

Optiscan Imaging (OIL) Endoscope Endoscopy procedures The company has designed and built a dual high-definition endomicroscopy endoscope.

Patrys (PAB) PAT- SM6 & PAT-LM1 Cancer treatment Pre-clinical studies of the two compounds have been completed.

Patrys (PAB) PAT-SM6 Colon cancer Pre-clinical animal studies have shown the drug to effectively prevent colon cancer metastases.

Tissue Therapies (TIS) VitroGro Wound healing cell therapy Two new formulations of the technology have shown positive pre-clinical results.

Phase I Total 20

Acuvax (ACU) Not disclosed Dengue fever vaccination A phase I trial is set to begin through subsidiary Hawaii Biotech.

Analytica (ALT) AutoStart Burette Not disclosed The first in-hospital trial of the device was successful.

BioDiem (BDM) SCH 900795 Live attenuated influenza vaccine Recruitment has been completed for a phase I trial of the drug.

bioMD (BOD) Gynecel Adapt biomaterial patch Pelvic reconstruction surgery A 20 patient clinical trial of the application has been approved.

Bionomics (BNO) BNC105 Solid cancerous tumours A phase I trial of the agent has been conducted in Melbourne.

BioProspect (BPO) Bioeffective A Horse health treatment A major study into the safety of the drug in the Arab Emirates has been announced.

Biota Holdings (BTA) BTA9881 Respiratory synctial virus treatment A phase I trial of the drug has been completed.

CSL (CSL) Not disclosed Swine flu CSL has kicked off a human clinical trial of its swine flu vaccine.

Fermiscan Holdings (FER) Hair sample test Breast cancer diagnosis The National Health Service of Italy has completed its first trial of the device.

Genera Biosystems (GBI) Not disclosed PapType human papilloma virus diagnostic

The large scale trial has shown positive results.

Living Cell Technologies (LCT) Choroid plexus cells Cell degeneration Studies with the Bionic Ear Institute have shown the cells prevent degeneration of inner ear cells.

Phosphagenics (POH) Oxycodone transdermal matrix patch system

Pain management Phosphagenics has successfully completed phase I clinical studies of the product.

Probiomics (PCC) Lactobacillus fermentum PCC Strengthening the immune system A clinical trial has found the drug was successful in preventing illness among cyclists.

Progen Pharmaceuticals (PGL) PG11047 Cell proliferation The company has completed a phase I monotherapy dose-escalation study.

pSivida (PVA) Iluvien Chronic back of the eye disease The company has reported the interim safety and efficacy results from the first human study of Iluvien.



Starpharma Holdings (SPL) VivaGel HIV prevention The gel has shown positive results in clinical testing.

Stirling Products (STI) Immunoxel Immunomodulator Clinical study results show a high cure rate of TB patients co-infected with HIV.

Sunshine Heart (SHC) C-Pulse Heart assist system The first patients fitted with the device have successfully completed their follow-up evaluation.

Virax Holdings (VHL) VIR201 HIV vaccine The vaccine has had positive results from a combined phase I/II trial in South Africa.

Viralytics (VLA) Cavatak Anti-cancer therapy Viralytics has completed its second phase 1 trial of novel anti-cancer therapy Cavatak.

Phase II Total 11

Antisense Therapeutics (ANP) ATL/TV1102 Multiple sclerosis Antisense has successfully completed a phase II trial of the sclerosis drug.

BioMD (BOD) CardioCel Biomedical patch Open-heart surgery phase II results show the patch has minimal side effects and performed to expectations.

Biotron (BIT) BIT225-003 Hepatitis C infection The clinical treatment stage of the phase II trial has been completed.

Clinuvel Pharmaceuticals (CUV) Afamelanotide Photoprotectant Positive results have been announced from a phase II trial.

Living Cell Technologies (LCT) Diabecell Insulin-dependent diabetes A combined phase I/II trial of the drug has begun in New Zealand.

Immuron (IMC) BioGuard Abnormal gastrointestinal inflammation associated HIV infection

69 out of 71 patients have been recruited for the phase IIb trial to be held in Australia.

Mesoblast (MSB) Adult stem cell treatment Minimally invasive lumbar spinal fusion surgery

The company has received FDA clearance to begin a phase II trial.

Mesoblast (MSB) Revascor Heart muscle function A phase II trial of the drug has begun.

Phosphagenics (POH) Diclofenac Inflammation Phosphagenics intends to start a combined phase II/III trial in the first quarter of 2010.

Prima BioMed (PRR) CVac Ovarian cancer vaccine The FDA has approved a phase II clinical trial of the vaccination.

QrxPharma (QRX) MoxDuo IV Intravenous morphine application A phase II comparative study of the drug has begun in New Jersey, US.

Phase III Total 6

Acrux (ACR) Axiron Testosterone deficiency Acrux has announced successful phase III trial results for Axiron.

Biota Holdings (BTA) CS-8958 Influenza treatment The phase III clinical trials of the product have shown positive results, meeting the primary and secondary endpoints.

Clinuvel Pharmaceuticals (CUV) Afamelanotide Phototoxicity diseases The drug has received European regulatory approval for phase III trials.

Peplin (PLI) PEP005 Gel Actinic solar keratoses Enrolment has been completed for the final phase III trial, initiated in the US.

Pharmaxis (PXS) Bronchitol Cystic fibrosis A second phase III trial of the drug has surpassed its initial recruitment target of 300 subjects.

QRxPharma (QRX) MoxDuo IR Moderate to severe pain A pilot study of the safety and efficacy of the drug has been successfully completed.

Other Total 4

Hexima (HXL) Not disclosed Anti-fungal for cotton plants The company has announced the third consecutive year of successful results.

Immuron (IMC) Bioguard HIV adjunct therapy Immuron has completed recruitment for a multicentre HIV adjunct therapy trial in Australia.

Novogen (NRT) NV-128 Induced caspase-independent DNA degradation and cancer cell death

A Novogen subsidiary has demonstrated NV-128 is effective in animal xenograft models without apparent toxicity.

Sirtex Medical (SRX) SIR-Spheres Colorectal cancer Final results of the Sirtex clinical trial have been published in the Journal of Clinical Oncology.

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Regulatory

Company Product Application Comments


Acrux (ACR) Axiron Testosterone deficiency Acrux plans to submit a New Drug Application (NDA) for the testosterone drug.

Avita Medical (AVH) Recell Spray-on skin The application has received regulatory approval from the Chinese Food and Drug Administration.

Benitec (BLT) Intellectual property RNAi DNA cells A patent covering a range of Benitec intellectual properties has been granted in the US.

BioPharmica (BPH) Tumour Suppressor Factor Tumour suppression The product has been issued a patent in the US.

Bone Medical (BNE) Capsitonin Osteoporosis drug salmon calcitonin The FDA has responded to an IND application, suggesting a 12 month phase III trial.

ChemGenex Pharmaceuticals (CXS) Omapro Chronic myeloid leukaemia The company has submitted a New Drug Application to the FDA.

Circadian Technologies (CIR) VEGF-C protein Wide spectrum of disease treatments The gene has received Japanese Patent 4324709 to treat diseases including cancer.

Cytopia (CYT) CYT387 Haematological disorders Cytopia’s Investigational New Drug Application for CYT387 has passed FDA review.

Cytopia (CYT) JAK2 Not disclosed Cytopia has extended its patent protection with another patent granted in the US.

Halcygen Pharmaceuticals (HGN) SUBA-Itraconazole Anti-fungal Halcygen has applied for EU registration of the drug.

Healthlinx (HTX) OvPlex ovarian cancer diagnostic test Ovarian cancer The test has received the CE mark and can therefore immediately be placed on the market in Europe.

Medical Therapies (MTY) Not disclosed Blood vessel narrowing treatment The company has been granted a European patent for the treatment.

Mesoblast (MSB) Autologous stem cell therapy Repair of non-healing long bone fractures

Mesoblast has applied for TGA licenses to commercially manufacture the therapy.

Novogen (NRT) Isoflavone phyto-oestrogen extracts Nutritional supplements Novogen’s patent claims for the products have been upheld by the European Patent Office.

Phylogica (PYC) PYC35 Anti-inflammatory The company has been granted a European patent for the drug.

Prana Biotechnology (PBT) Hydroxyquinoline compounds Neurological disease treatment The European Patent Office has granted a patent for the compounds.

Prima BioMed (PRR) Cripto-1 Cancer A subsidiary of Prima BioMed has received a patent for Cripto-1 from the Republic of South Korea Patent Office.

Prima BioMed (PRR) CVac Ovarian cancer therapy vaccine The company has submitted an Investigational New Drug application for the vaccine to the FDA.

Solagran (SLA) Nuvanta Conifer Green Needle Complex Vegicaps

Bioeffective A herbal product The drug has received regulatory approval in Malaysia.

Starpharma Holdings (SPL) SPL7013 Sexually transmitted infections The company has been granted a key patent in the US specifically relating to the use of SPL7013.

Tissue Therapies (TIS) VitroGro Tissue engineering technology Two additional VitroGro patents have been granted in Australia and South Korea.


Advanced Surgical Design and Manufacture (AMT)

AllVascular Peripheral Access Device (PAD)

Isolated organ and isolated limb chemotherapy

The product has received Class IIa approval from the TGA.

BioMD (BOD) Adapt Tissue engineering The device has received a patent from the South Africa Patent Office.



Cathrx (CXD) Loop catheter Cardiac arrhythmia The device has received CE marking and can therefore be distributed in Europe.

Cochlear (COH) Cochlear Nucleus 5 System Not disclosed The two pre-market supplements have received FDA approval.

Fermiscan Holdings (FER) Hair sample test Breast cancer diagnosis The device has received the CE mark and can therefore be freely marketed in Europe.

Karmelsonix (KSX) PulmoTrack Cough detection The device has received the CE mark and can therefore be freely marketed in Europe.

KarmelSonix (KSX) Wheezometer Wheeze rate measure The Wheezometer has been granted 510k marketing clearance by the FDA.

Labtech Systems (LBT) MicroStreak Agar plate streaking technology The technology has been granted a patent by the Australian Patent Office.

Nanosonics (NAN) Trophon EPR Disinfection and sterilisation technology

The FDA has completed an initial review of device, which is awaiting 510k approval.

Occupational and Medical Innovations (OMI)

Auto retractable syringe Medical syringe TUV SUD Japan has successfully completed a certification audit of the device.

Unilife Medical Solutions (UNI) Unitract 1m insulin syringe Unilife has commenced syringe production in the US, having received regulatory certificates in the US, Canada and Europe.

Uscom (UCM) Pacemaker Cardiac function The company has received a new patent from the US Patent Office for a method of optimising pacemakers.

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Other news



Acuvax (ACU) The company has formed Acuvax Immunology Services, a wholly owned subsidiary for marketing recombinant and other technologies.

Acuvax (ACU) Non-executive director David Sanders has resigned from the board of Acuvax.

Agenix (AGX) The company’s Singapore based CEO Dr Stephen Phua has been advised that his contract will not be renewed.

Avexa (AVX) CSIRO will invest up to $2m into Avexa’s hepatitis C drug as part of the Australian Growth Partnerships program.

Benitec (BLT) Peter French has joined the company as chief scientific officer.

BioDiem (BDM) Julie Phillips has been appointed CEO of the company.

BioPharmica (BPH) BioPharmica announced plans to list its subsidiary Molecular Discovery Systems.

BioPharmica (BPH) Seng Yep has resigned as a director and Deborah Ambrosini has been appointed as a director.

BioProspect (BPO) BioProspect appoints Leo Khouri as a non-executive director.

ChemGenex (CXS) Don Santel, Julie Cherrington and Dennis Brown have all resigned from the board.

Colltech Australia (CAU) The company has voted to change its name to Holista Colltech Limited. C.H. (Mick) ?? was appointed to the board.

Cytopia (CYT) Cytopia has appointed Ashley Arnott as chief financial officer and company secretary.

Hexima (HXL) Undisclosed Insect resistance technology The company has received a Federal Government Climate Ready grant of $1.38m, payable over three years, for its agricultural technology.

Living Cell Technologies (LCT) The founder and former CEO of the company, David Collinson, has passed away.

Living Cell Technologies (LCT) Living Cell Technologies has appointed Bob Finder and David McAuliffe as independent directors and Dr David Brookes as chairman.

Medical Developments International (MVP)

The company has appointed Usha Charan as company secretary following the resignation of Jonathan Kadish.

Probiomics (PCC) Stuart Craig has resigned as CEO.

Progen Pharmaceuticals (PGL) The company has instituted proceedings in the Supreme Court against several shareholders for contravention of the Corporations Act.

Solagran (SLA) Robert Payne resigned as non executive director and was replaced as company secretary by Justin Stedwell. Andi Solaiman was appointed as a non-executive director.

Select Vaccines (SLT) Robin Beaumont has resigned as a director and chairman. Shane Allen has been appointed chairman.

Stirling Products (STI) The company has appointed Neil Covey as a non-executive director who will replace George Karontzias.




ATOS Wellness (ATW) Simon Coad has been appointed as voluntary administrator of ATOS subsidiary Letchworth House.

ATOS Wellness (ATW) The board members have resolved to put ATOS into voluntary liquidation.

Avastra Sleep Centres (AVS) Voluntary administrators have been appointed to liquidate Avastra.

CathRx (CXD) CathRx has appointed a new CFO in preparation of the company’s next phase of development.

Compumedics (CMP) The company’s Germany based ultrasonic blood flow business has won a $215k deal in China.

CordLife (CBB) Seow Bao Shuen has resigned as a director.

Eastland Medical Systems (EMS) Trevor Strahan has tendered his resignation as company secretary replaced by Demot Patterson. Peter Tiede also resigned as CFO.

Fermiscan Holdings (FER) David Young managing director and Grey West, CFO and company secretary have both resigned. The company announced the appointment of Ian Chalmers and Mark Fordree to the board, replacing Gary Gorton and Leon Carr.

IM Medical (IMI) Roman Najdecki has been reappointed as CEO and CFO for a further two years.

Impedimed (IPD) The role of CFO has been relocated to the US, in order to support expansion across the US. Stephen Denaro has been appointed as company secretary, replacing Mr Auckland.

ITL (ITD) Greg Lewis has resigned as CFO and has been replaced by Angelo Tsagarakis.

KarmelSonix (KSX) Wheezometer Handheld wheeze quantification device

The first run of the device has been rolled out, with sales to commence shortly.

Karmelsonix (KSX) Paul Eisen has been appointed vice president, sales and marketing, for Australia and Asia Pacific.

Medical Corporation Australasia (MOD) Jiang Hai (James) Chen has tendered his resignation as a non-executive director.

Medic Vision (MVH) Medic Vision has appointed Indrajit Arulampalam as executive chairman.

Medivac (MDV) Medivac has appointed Michael Kornitschuk as general manager of its subsidiary SunnyWipes.

Medivac (MDV) Medivac subsidiary Diakyne has instigated Federal Court proceedings against former director Paul Ralph to recover a $110k payment.

Neurodiscovery (NDL) John Hannaford has resigned from the board. Dr Chris Moyses has resigned as CEO and as a director of the company.

Polartechnics (PLT) The company has been placed into voluntary administration after a lack of working capital to continue operations.

Ventracor (VCR) The company has been placed into liquidation and operations have been wound down.

Vision Group Holdings (VGH) The company has instituted proceedings against former executive Director Dr Kitchen in the Supreme Court of Queensland, following the termination of a service agreement.

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Partnerships

Company Pharma/biotech partner Application Value (US$m) Comments


Abbott Laboratories GlaxoSmithKline Not disclosed Not disclosed Strategic alliance to develop an automated molecular diagnostic test.

Bio-Matrix Scientific Gr Therinject Immuno-therapeutic cancer vaccine

Not disclosed Strategic alliance for the development of a new immuno-therapeutic cancer vaccine.

BioFocus DPI Oncodesign SRL Oncology Not disclosed Strategic alliance to offer a comprehensive oncology drug discovery service.

DARA BioSciences America Stem Cell Haematopoietic stem cell (HSC) transplants

Not disclosed Strategic alliance to increase their scope of stem cell research.

DxS Horizon Discovery Cancer Not disclosed Strategic alliance to develop tests for patient responses to certain cancer medications.

Ferozsons Laboratories Bago Group Hepatitis and cancer Not disclosed Joint venture to produce medicine for hepatitis and cancer.

FEI Sematech Not disclosed Not disclosed The companies have planned to form a strategic alliance.

GlaxoSmithKline Concert Pharmaceuticals Not disclosed Not disclosed Strategic alliance to develop and commercialise deuterium-containing medicines.

Johnson & Johnson Elan Alzheimer’s immunotherapy program

US$1b Joint venture between J&J and Elan for the development of Elan and Wyeth’s Alzheimer’s immunotherapy program.

Institute for OneWorld Health

Novartis AG and Novartis Institutes

Secretory diarrhoea Not disclosed Strategic alliance to provide research and development services for a novel therapy for secretory diarrhoea.

Parenteral Drugs Mascareignes Pharmaceutical Manufacturing

Not disclosed Not disclosed Joint venture to set up a plant that will manufacture pharmaceutical products.

Rexahn Pharmaceuticals Korea Research Institute of Chemical Technology

Not disclosed Not disclosed Strategic alliance for the development of a synthetic process for Quinoxalines compounds.

Sirius Genomics Assistance Publ Hopitaux Paris

Severe sepsis Not disclosed Strategic alliance to provide research and development services regarding genomic correlations for severe sepsis patients.

Shanghai ChemPartner Agios Pharmaceuticals Not disclosed Not disclosed Strategic alliance to expand the integrated drug discovery research.

Thomson Reuters Sagient Research Systems Not disclosed Not disclosed Strategic alliance to provide research services.


Health Robotics iv SOFT Software automation modules

Not disclosed Joint venture to market and support software automation modules to hospitals and infusion centres in North America.


Mergers, acquisitions and divestments

Dominant company Target company Type of deal Value (US$m) Comments


Abbott Laboratories NeoGenomics Acquisition US$4.8m Abbott Laboratories has acquired an 11% stake in NeoGenomics.

Adolor Eli Lilly Acquisition US$72m Adolor has acquired the OpRA III assets of Eli Lilly, a manufacturer and wholesaler of pharmaceuticals.

Adurjee & Bros Orchid Chemicals & Pharmaceuticals

Acquisition US$6.6m Adurjee & Bros has acquired a further 4% stake.

Amexdrug BioRx Laboratories Acquisition Not disclosed Amexdrug has acquired BioRx Laboratories, a manufacturer and wholesaler of pharmaceutical and natural care products.

Arseus NV Duo-Med SA Acquisition Not disclosed Arseus NV has acquired Duo-Med, a provider of surgical devices.

Astellas Pharma Maxygen Merger Not disclosed Astellas Pharma has merged its operations with the technology assets of Maxygen.

Atrium Innovations Garden of Life Acquisition US$37.5m Atrium Innovations has acquired Garden of Life, a manufacturer and wholesaler of nutritional supplement products

Braganza AS Clavis Pharma ASA Acquisition US$2.4m Braganza AS has acquired a 9% stake in Clavis Pharma.

Bristol-Myers Squibb Medarex Acquisition US$2.2b Bristol has acquired the entire share capital of Medarex.

Carbonics Capital Sustainable Systems Acquisition US$4m Carbonics Capital has acquired the entire share capital of Sustainable Systems.

Cell Therapeutics Not disclosed Divestment US$1.1m Cell Therapeutics has divested its research centre in Bresso to an undisclosed acquirer.

Cleveland Clinic Foundation

FTA Therapeutics Acquisition Not disclosed Cleveland Clinic Foundation has acquired an undisclosed minority stake in FTA Therapeutics, a manufacturer of clinical stage pharmaceuticals.

Charles River Laboratories

Cerebricon Acquisition US$9m Charles River Laboratories International has acquired Cerebricon.

Cornerstone Therapeutics

Oscient Pharm Corp Acquisition US$5m Cornerstone Therapeutics has acquired the Factive unit of Oscient Pharmaceuticals.

Evotec AG Research Support International

Acquisition US$2.3m Evotec AG has acquired a 70% interest in Research Support International.

Financiere Elitech SAS Nanogen Acquisition US$25.7m The company has acquired the entire share capital of bankrupt Nanogen, a manufacturer of medical diagnostic systems and products.

Foster Supply Pharmacy Associates Acquisition Not disclosed Foster Supply has acquired Pharmacy Associates.

GlaxoSmithKline Bristol-Myers Squibb Acquisition US$23.2m GlaxoSmithKline has acquired the branded generics business in Lebanon, Jordan, Syria, Libya and Yemen of Bristol-Myers Squibb.

Generic Health Max Pharma Acquisition Not disclosed Generic Health has acquired Max Pharma, a manufacturer of pharmaceuticals.

GKB Global Freedom Eye Acquisition US$100k GKB Global has acquired a 9% stake in Freedom Eye.

Hanford Pharmaceuticals Not disclosed Divestment Not disclosed Hanford Pharmaceuticals has divested its cephalosporin manufacturing facility.

Herbalife Micelle Laboratories Acquisition Not disclosed Herbalife has acquired certain assets of Micelle Laboratories, a manufacturer of pharmaceuticals.

JCR Pharmaceuticals Bio Matrix Research Acquisition US$0.5m JCR Pharmaceuticals has acquired an 8% stake in Bio Matrix Research.

Jhc Nederland BV Crucell NV Acquisition US$444m JHC Nederland BV, a unit of Johnson & Johnson, has acquired an 18% stake in Crucell NV.

Lamba Partners Alapis SA Acquisition US$128m Lamba Partners has acquired a 20% stake in Alapis SA, a manufacturer and wholesaler of pharmaceutical products.

LMA International NV LMA Urology Acquisition US$1.1m LMA International NV has acquired a 12.5% stake in LMA Urology.

Lupin Oscient Pharmaceuticals Acquisition US$39m Lupin has acquired the Antara cardiovascular drug product line (Antara) of bankrupt Oscient Pharmaceuticals.

NeoMed Innovation III Clavis Pharma ASA Acquisition US$2.8m NeoMed has acquired a 10% stake in Clavis Pharma ASA.

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Northstar Merger Sub Noven Pharmaceuticals Acquisition US$400m The company has acquired the remaining 95% interest plus options in Noven Pharmaceuticals.

Novartis Pharma AG BTG Acquisition US$10m Novartis Pharma AG has acquired Hysolv, a drug delivery technology owned by BTG.

OSI Pharmaceuticals AVEO Pharmaceuticals Acquisition US$20m OSI has raised its stake to an undisclosed minority stake in AVEO Pharmaceuticals.

PerkinElmer SYM-BIO Lifescience Acquisition US$63.8m PerkinElmer has acquired SYM-BIO Lifescience.

Perrigo Vedants Drugs & Fine Chem Acquisition US$12m Perrigo has acquired an 85% interest in Vedants Drugs & Fine Chemicals.

Pierian iZumi Bio Merger Not disclosed iZumi Bio has been merged with Pierian, to form a new company named iPierian.

PuriCore Labcaire Systems Acquisition US$4.6m PuriCore has acquired the entire share capital of Labcaire Systems.

Qiagen NV DxS Acquisition US$130m Qiagen NV has acquired DxS.

Quest Pharmatech Paladin Labs Acquisition US$0.4m The company has acquired certain assets of Paladin Labs, a manufacturer of pharmaceuticals.

RWE Innogy Mantex AB Acquisition US$1.6m RWE Innogy GmbH has acquired an undisclosed minority stake in Mantex AB.

Sanofi-Aventis SA Merck & Co Acquisition US$4b Sanofi-Aventis SA has planned to acquire a 50% stake in Merial, from Merck & Co.

Sergeant’s Pet Prod Care MGP Ingredients Acquisition US$3.6m The company has acquired the manufacturing facility of MGP Ingredients, a producer of starches and protein.

Sigma Pharmaceuticals Bristol-Myers Squibb Acquisition US$51.1m Sigma Pharmaceuticals has acquired a manufacturing facility from Bristol-Myers Squibb.

Thornton & Ross Zeroderma Acquisition Not disclosed Thornton & Ross has acquired Zeroderma.


3M Becton Dickinson Acquisition Not disclosed 3M has acquired the ACE brand of Becton Dickinson, a manufacturer and wholesaler of medical products.

Abbott Laboratories Visiogen Acquisition US$400m Abbott has agreed to acquire Visiogen, a manufacturer of ophthalmic products.

Agilent Technologies Varian Acquisition US$1.5b The company has agreed to acquire the entire share capital of Varian, a wholesaler of scientific instruments.

Alcon ESBATech AG Acquisition US$589m Alcon has agreed to acquire the entire share capital of ESBATech AG, a biotechnology company.

Block Imaging Intl Benchmark Radiology Acquisition Not disclosed Block Imaging has acquired Benchmark Radiology, a medical equipment wholesaler.

Cardinal Health Care Fusion Spin-off Not disclosed The company has planned to spin off an 80% interest in its medical technology unit Care Fusion.

Cell Biosciences Alpha Innotech Acquisition US$18.5m The company has agreed to acquire the entire share capital of Alpha Innotech.

Cortec Group 180 Medical Acquisition Not disclosed Cortec Group has acquired an undisclosed majority interest in 180 Medical, a medical equipment wholesaler.

Cortec Group Katena Products Acquisition US$23.5m Cortec Group has acquired Katena Products, a manufacturer and supplier of precision manufactured micro instruments for ophthalmic surgeries.

Danaher Align Technology Acquisition US$77m Danaher has agreed to acquire an 11% stake in Align, a manufacturer and wholesaler of medical equipment.

Danaher Applied Biosystems/MDS Sciex

Acquisition US$450m Danaher has agreed to acquire the remaining 50% interest in Applied Biosystems/MDS Sciex.

Danaher MDS Analytical Technologies Acquisition US$650m Danaher has agreed to acquire MDS Analytical Technologies, an analytical instruments manufacturer.

Data Physics Corp Qualmark Acquisition Not disclosed The company has acquired the Ling & ACG Electrodynamic Shaker business assets of Qualmark.

Dionex ESA Biosciences Acquisition Not disclosed Dionex Corp has acquired certain assets of ESA Biosciences, a manufacturer and wholesaler of analytical instruments.

Gen-Probe Spin-off entity Divestment Not disclosed The company plans to spin off its industrial testing assets to its shareholders.

Haemonetics SEBRA-Blood Collection Acquisition US$12.5m The company plans to acquire the blood collection and processing business unit of Engineering and Research Associates.



Harvard Bioscience Denville Scientific Acquisition US$24m Harvard Bioscience has acquired Denville Scientific.

ICU Medical Hospira Acquisition US$35m ICU Medical has acquired the critical care product line of Hospira.

Ingen Technologies Comfort Medical Supply Acquisition US$100k Ingen plans to acquire Comfort Medical Supply, a manufacturer of medical equipment.

Integra Biosciences Viaflo Acquisition Not disclosed The company has agreed to acquire the entire share capital of Viaflo, a pipette manufacturer.

Integra Spine Innovative Spinal Technologies

Acquisition US$9.3m Integra Spine has acquired bankrupt company Innovative Spinal Technologies.

Intra-Op Monitoring Svcs Neuraxis Monitoring Group Acquisition Not disclosed The company has acquired Neuraxis Monitoring Group, a manufacturer of neurophysiological monitoring equipment.

IntriCon Datrix Acquisition US$2.5m IntriCon has acquired Datrix, a manufacturer of cardiac diagnostic monitoring equipment.

Koninklijke Philips Electronic

InnerCool Therapies Acquisition US$12.8m The company has acquired InnerCool Therapies, a medical devices manufacturer.

McCoy Enterprises Cavit Sciences Merger Not disclosed Agreement to merge with biotechnology company Cavit.

Medical Imaging Holdings

Barrington Medical Imaging Acquisition Not disclosed The company has acquired Barrington Medical Imaging, a manufacturer of medical equipment.

Millipore BioAnaLab Acquisition Not disclosed Millipore has acquired the entire share capital of BioAnaLab, a provider of biopharmaceutical research services.

MyoCardioCare Biophan Tech Acquisition US$250k MyoCardioCare has acquired the Myotech Circulatory Support System business from Biophan Technologies.

Natus Medical Alpine Biomed Acquisition US$43.2m Natus Medical has agreed to acquire the entire share capital of Alpine Biomed, a medical equipment wholesaler.

Natus Medical Hawaii Medical Acquisition US$2.9m and profit-related payments

The company has acquired Hawaii Medical, a disposable medical products manufacturer.

PerkinElmer GE Healthcare Acquisition Not disclosed PerkinElmer has acquired the catalogue radiochemicals, SPA reagents and Cytostar-T assets of GE Healthcare.

QuantRX Biomedical Pria Diagnostics Acquisition US$0.7m The company has agreed to acquire the intellectual property and certain fixed assets of Pria Diagnostics.

Rotech Healthcare MedSafety Acquisition Not disclosed Rotech has acquired MedSafety, a wholesaler of medical and dental equipment.

Sanarus Technologies Sanarus Medical Acquisition Not disclosed Sanarus Technologies has acquired Sanarus Medical, a manufacturer of invasive medical devices.

Sanvita CBGM Sanvita Acquisition Not disclosed The company has acquired certain assets of Sanvita, a manufacturer of pharmaceuticals.

Sunridge International Ophthalmic International Acquisition Not disclosed The company has acquired the entire share capital of Ophthalmic International, a medical equipment developer.

St Jude Medical Micell Technologies Acquisition US$15m The company has acquired an undisclosed minority stake in Micell Technologies, a manufacturer of medical devices.

Syneron Medical Candela Acquisition US$64.9m Syneron Medical has agreed to acquire Candela Corp, a manufacturer of medical lasers.

Synovis Surgical Sales Pegasus Biologics Acquisition US$12.1m The company has acquired Pegasus Biologics, an Irvine-based manufacturer of medical devices.

Transformer Delaware Aspect Medical Systems Acquisition US$209m The company has agreed to acquire Aspect Medical Systems, a manufacturer of brain monitoring systems.

United Medical Systems MoBx Mobile Breast Services Acquisition Not disclosed The company has acquired MoBx Mobile Breast Services.

West Pharmaceutical Services

Plastef Investissements Acquisition Not disclosed The company has acquired the drug delivery assets of French company Plastef.

Wi Acquisition MedX Systems Merger Not disclosed Wi has agreed to merge with medical equipment manufacturer MedX.

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Clinical trials


Pre-clinical Total 0

Phase I Total 0

Phase II Total 1

Bioheart MyoCell Heart failure and other cardiovascular diseases

Bioheart has presented positive efficacy data from part 1 of its phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston.

Phase III Total 6

AstraZeneca Ticagrelor Reduction of cardiovascular events The company has announced positive results from its phase III study of the antiplatelet drug.

Can-Fite BioPharma CF101 Psoriasis The company has announced the initiation of preparatory work for a phase III trial.

Celsion ThermoDox Primary liver cancer The Data Safety Monitoring Board has recommended that the trial continue based on the safety data from the first group of patients enrolled in its phase III clinical trial.

Cerus Intercept Blood System Transfusion-transmitted diseases Cerus plans to present the proposed design for a U.S. phase III clinical trial at a meeting of the FDA’s Blood Products Advisory Committee.

Dainippon Sumitomo Pharma Lurasidone Schizophrenia The company has announced positive results from its phase III clinical trial.

Vivius Qnexa Improvements in cardiovascular and metabolic risk factors

The company has announced positive results from two final, phase III pivotal 56-week studies.

Other Total 1

Osiris Therapeutics Prochymal Graft versus host disease (GvHD) The company has announced that two late-stage trials testing its lead product have failed to meet the main study goals.


Regulatory



Actelion Tracleer (bosentan) Mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH)

The FDA has approved the company’s supplementary new drug application for the product.

APP Pharmaceuticals Deferoxamine Mesylate Iron poisoning as well as chronic iron overload due to transfusion-dependent anaemias

The company has received approval from the FDA to market the product.

Caraco Pharmaceutical Laboratories Bicalutamide Stage D2 metastatic carcinoma of the prostate

The company has launched Bicalutamide tablets on behalf of Sun Pharmaceutical Industries.

Cell Therapeutics Pixantrone Aggressive Non-Hodgkin’s Lymphoma (NHL)

Cell Therapeutics has applied to the European Medicines Agency for orphan drug designation for pixantrone.

Cepheid Xpert HemosIL FII & FV test Detection of Factor II and V Leiden genetic variations linked with thrombophilia

Xpert HemosIL FII & FV test has been approved by the FDA.

Generex Biotechnology Generex Oral-lyn Diabetes The FDA has approved experimental use of the company’s product.

Genentech Avastin (bevacizumab) plus interferon-alfa

Kidney cancer and metastatic renal cell carcinoma

The FDA has approved the product for both applications.

Genzyme Clolar Paediatric leukaemia Genzyme is to run a new study in order to win approval to promote the drug.

GENova Biotherapeutics Prostaganin Peptide for prostate cancer GENova is preparing for patent application filings for the product in both the US and Europe.

Grifols Niuliva 250 IU/ml Human anti-hepatitis B immunoglobulin for intravenous administration

Grifols has launched the product in Spain and Italy.

Lombard Medical Technologies Aorfix Abdominal aortic aneurysm The FDA has accepted and closed the first of six modules of the company’s pre-market approval filing plan for Aorfix.

Lumavita Pentamycin Infectious vaginitis Lumavita has announced its first product approval by the Swiss regulatory authority.

MediGene Veregen Genital warts MediGene has received German marketing authorisation for its product from the Federal Institute for Drugs and Medical Devices.

Medtronic Medtronic Deep Brain Stimulation (DBS) Therapy

Medically refractory epilepsy with partial-onset seizures

Medtronic has submitted a pre-market approval application for the product to the FDA.

NicOx Naproxcinod Osteoarthritis An application for naproxcinod has been submitted to the FDA.

Novo Nordisk Novolog Subcutaneous Injection Diabetes The FDA has announced approval of NDA 020986 for Novolog Subcutaneous Injection.

Ortho Clinical Diagnostic VITROS Anti-HCV assay Hepatitis C testing The company has received FDA approval for the product.

Paladin Labs GlucaGen Severe hypoglycemia in diabetic patients

The Biologics and Genetic Therapies Directorate of Health Canada has approved the product.

Protalix BioTherapeutics prGCD Gaucher disease The company has been granted fast track designation from the FDA for prGCD.

Roche MabThera Relapsed or refractory chronic lymphocytic leukaemia

Roche has received European Commission approval for the product.

Sanofi-Aventis and UCB Xyzal Allergy treatment

Sanofi-Aventis Lantus Injection Diabetes The FDA has announced approval of NDA 021081.

Savient Pharmaceuticals Krystexxa Gout The FDA has declined to approve the company’s gout drug.

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Actelion Tracleer (bosentan) Mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH)

The FDA has approved the company’s supplementary new drug application for the product.

APP Pharmaceuticals Deferoxamine Mesylate Iron poisoning as well as chronic iron overload due to transfusion-dependent anaemias


Caraco Pharmaceutical Laboratories Bicalutamide Stage D2 metastatic carcinoma of the prostate

The company has launched Bicalutamide tablets on behalf of Sun Pharmaceutical Industries.

Cell Therapeutics Pixantrone Aggressive Non-Hodgkin’s Lymphoma (NHL)

Cell Therapeutics has applied to the European Medicines Agency for orphan drug designation for pixantrone.

Cepheid Xpert HemosIL FII & FV test Detection of Factor II and V Leiden genetic variations linked with thrombophilia

Xpert HemosIL FII & FV test has been approved by the FDA.

Generex Biotechnology Generex Oral-lyn Diabetes The FDA has approved experimental use of the company’s product.

Genentech Avastin (bevacizumab) plus interferon-alfa

Kidney cancer and metastatic renal cell carcinoma

The FDA has approved the product for both applications.

Genzyme Clolar Paediatric leukaemia Genzyme is to run a new study in order to win approval to promote the drug.

GENova Biotherapeutics Prostaganin Peptide for prostate cancer GENova is preparing for patent application filings for the product in both the US and Europe.

Grifols Niuliva 250 IU/ml Human anti-hepatitis B immunoglobulin for intravenous administration

Grifols has launched the product in Spain and Italy.

Lombard Medical Technologies Aorfix Abdominal aortic aneurysm The FDA has accepted and closed the first of six modules of the company’s pre-market approval filing plan for Aorfix.

Lumavita Pentamycin Infectious vaginitis Lumavita has announced its first product approval by the Swiss regulatory authority.

MediGene Veregen Genital warts MediGene has received German marketing authorisation for its product from the Federal Institute for Drugs and Medical Devices.

Medtronic Medtronic Deep Brain Stimulation (DBS) Therapy

Medically refractory epilepsy with partial-onset seizures

Medtronic has submitted a pre-market approval application for the product to the FDA.

NicOx Naproxcinod Osteoarthritis An application for naproxcinod has been submitted to the FDA.

Novo Nordisk Novolog Subcutaneous Injection Diabetes The FDA has announced approval of NDA 020986 for Novolog Subcutaneous Injection.

Ortho Clinical Diagnostic VITROS Anti-HCV assay Hepatitis C testing The company has received FDA approval for the product.

Paladin Labs GlucaGen Severe hypoglycemia in diabetic patients

The Biologics and Genetic Therapies Directorate of Health Canada has approved the product.

Protalix BioTherapeutics prGCD Gaucher disease The company has been granted fast track designation from the FDA for prGCD.

Roche MabThera Relapsed or refractory chronic lymphocytic leukaemia

Roche has received European Commission approval for the product.

Sanofi-Aventis and UCB Xyzal Allergy treatment

Sanofi-Aventis Lantus Injection Diabetes The FDA has announced approval of NDA 021081.

Savient Pharmaceuticals Krystexxa Gout The FDA has declined to approve the company’s gout drug.

Shire Velaglucerase alfa Gaucher disease treatment Shire has sent its Gaucher disease treatment to the FDA for approval ahead of schedule.

Shire Intuniv Attention-deficit/hyperactivity disorder Shire has received the FDA’s approval for Intuniv extended release tablets.

Sirion Therapeutics Zirgan Acute herpetic keratitis. The FDA has approved the new drug application.



Staar Surgical Toric implantable collamer lens (TICL) Vision correction The FDA has removed certain restrictions on the company’s product.

SyntheMed Repel-CV Reduction of adhesions following cardiac surgery

SyntheMed has received approval from the Brazilian Ministry of Health for use in all patients who undergo open-heart surgery.

Teva Pharmaceutical Industries Oxaliplatin Injection Stage III colon cancer Teva announced FDA approval and the launch of the product.

Trinity Biotech Destiny Max Haemostasis Trinity Biotech has announced the FDA’s approval and the US launch of the product.

United Therapeutics Tyvaso inhalation solution Pulmonary arterial hypertension or PAH

United Therapeutics has received the FDA’s approval for the product.


Abbott Laboratories Xience Coronary Stent System Coronary artery disease The device has received approval from Health Canada.

Active Implants TriboFit Hip System Hip joint reconstruction The company has received a CE Class III Certificate for the device.

AGA Medical Amplatzer vascular plug, AVP 4 Circulatory and internal organ diseases

The company has received European CE Mark approval for the product.

Allergan Acuvail Pain and inflammation following cataract surgery

The FDA has approved the product.

American Scientific Resources Disintegrator Home needle destruction device The company has acquired the intellectual property to the FDA-approved device.

Antisense Pharma Trabedersen Pancreatic carcinoma The company has received orphan drug designation from both the European Medicines Agency and the FDA for its product.

APP Pharmaceuticals Deferoxamine Mesylate Iron poisoning and chronic iron overload due to transfusion-dependent anaemias


APP Pharmaceuticals Penicillin G potassium Bacterial infections The company has received approval from the FDA to market the product.

BioDelivery Sciences International and Meda AB

Onsolis (fentanyl buccal soluble film) Breakthrough pain (BTP) in patients with cancer

BioDelivery has received approval to market the product.

Boston Scientific Taxus Liberte Long Paclitaxel-Eluting coronary stent system

Patients with long lesions The company has received approval from the FDA to market the drug.

Caldera Medical Ascend Pelvic Floor Repair System with Apical Support

Female pelvic organ prolapse Caldera Medical has received FDA clearance and CE Mark certification.

CellaVision AB CellaVision DM1200 Preliminary differential count on peripheral blood

The company has received official approval for the product.

Chesson Labs Nuvaderm Liquid bandage Chesson Labs has received 510(k) market clearance from the FDA for the product.

ClearStream Technologies Group Cobalt Chromium (CoCr) stent Coronary disease The company has received regulatory approval to sell the product.

Cordis Cypher Sirolimus-eluting coronary stent

Coronary blockages in small vessels The company has received approval from the FDA for a new, smaller version of the device.

CorNova Valecor Platinum Coronary Stent System

Coronary disease CorNova has announced that it has received CE mark approval for the device.

Covidien DuraSeal spine sealant Intra-operative dural sealing in spine procedures

The FDA has approved DuraSea spine sealant for use in the US.

CryoLife BioFoam Surgical Matrix Adjunct in the sealing of abdominal parenchymal tissues (liver and spleen)

CryoLife has received CE mark approval for the product.

Flexible Stenting Solutions FlexStent Femoropopliteal Self Expanding Stent System

Femoropopliteal arteries The company has received conditional investigational device exemption approval for the product.

Hansen Medical Sensei X Robotic Catheter System Electrophysiology procedures Hansen Medical has received FDA clearance for its next generation Sensei X Robotic Catheter System.

Heart Force Medical Digital Ballistocardiograph Cardiac care The company has received FDA clearance for the product.

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Hologic Adiana permanent contraception system

Permanent contraception procedure The FDA has approved the company’s pre-market approval application for the system.

Hologic ThinPrep Integrated imager Hologic has received CE Mark approval for the product.

HyperBranch Medical Technology NuSeal 100 Cranial neurosurgical procedures The company has received a CE Mark for the NuSeal 100 dural sealant

IMRIS IMRISNV Stroke management and advanced neurovascular interventions

The FDA has granted 510(k) clearance for the company’s product.

IMRIS IMRIScardio Cardiovascular interventions The FDA has granted 510(k) clearance for the company’s product.

Integra LifeSciences Hallu-Lock MTP arthrodesis system Orthopaedic surgery Integra LifeSciences has received FDA 510(k) clearance and CE Mark approval in the EU for the product.

Medtronic Reclaim(R) Deep Brain Stimulation (DBS) Therapy

Chronic, severe treatment-resistant obsessive-compulsive disorder (OCD)

Medtronic has received CE Mark approval for the product.

Meridian Bioscience Seasonal influenza test Swine flu The company has received FDA clearance to market its seasonal influenza test.

NeuroVasx cPAX aneurysm treatment system Embolisation of cerebral aneurysms, abnormal bulges or sacs in the wall of an artery in the brain

NeuroVasx has received approval to market the treatment system in Canada from the Health Canada’s Therapeutic Products Directorate.

Nfocus Neuromedical Echo Distal Access Catheter Peripheral, coronary and neurovascular interventional and diagnostic procedures

The company has obtained CE Mark approval for the guiding catheter.

Nucryst Pharmaceuticals Acticoat Flex Antimicrobial barrier dressing The FDA granted marketing clearance for the product

Onset Medical SoloPath Endovascular Access Catheter

Aortic aneurysms Onset Medical has received CE Mark approval to begin marketing the company’s product in the European Union.

Ortho Clinical Diagnostics VITROS Anti-HCV assay Hepatitis C testing The FDA has approved the device.

Orthofix International Advent Cervical Disc Treatment of degenerative or traumatic disc conditions

The company has received CE Mark approval for the product.

Oticon Medical Ponto bone anchored hearing system Hearing solution The FDA has granted 501(k) marketing clearance for the product.

Physio-Control Lucas 2 Consistent, uninterrupted compressions to victims in cardiac arrest.

The product has been granted 510(k) market clearance by the FDA.

Prescient Medical vProtect Luminal Shield Stent System Improving coronary artery luminal diameter

The company has been granted a CE Mark approval to commercialise the product.

Quest Diagnostics Focus Diagnostics business Detecting the 2009 H1N1 influenza virus

The FDA has granted an emergency use authorisation to the company’s Focus Diagnostics business for the test.

Response Biomedical Respiratory Syncytial Virus (RSV) test RSV diagnosis The FDA has granted the company 510(k) clearance to market the test.

Reverse Medical ReStore Microcatheter Neurothrombectomy Reverse Medical has received FDA conditional approval to begin a neurothrombectomy IDE study for the product.

Roche Valcyte Cytomegalovirus Disease in paediatric patients

The FDA has approved the device.

SpectraScience WavSTAT platform technology Cancer screening The company received FDA approval of the product.

Spectranetics Turbo-Tandem Atherectomy of infrainguinal arteries Spectranetics has received clearance from the FDA to market the product.

Stentys Stentys bifurcation stent Coronary artery bifurcations Stentys has received CE Mark approval of its disconnectable and self-expanding platform for treatment of coronary artery bifurcations.

St. Jude Medical EnSite Velocity Cardiac Mapping System

Treat abnormal heart rhythms The company has announced FDA clearance and the U.S. launch of the product.

St. Jude Medical Brio neurostimulator Parkinson’s disease The company has announced CE Mark approval of the Brio neurostimulator.



Ulthera Ulthera System Non-invasive eyebrow lift The FDA has granted clearance for the use of the product .

Varian Medical Systems Acuros capability Brachytherapy treatment planning system

The company has obtained FDA 510(k) clearance for the product.

Vascular Designs IsoFlow infusion catheter Cancer Vascular Designs has secured 510(k) marketing clearance by the FDA.

W. L. Gore & Associates Gore Viabahn Endoprosthesis Vascular problems The company has received FDA approval to market the product.

Zoll Medical LifeVest wearable defibrillator Long-term arrhythmic risk Zoll Medical has received approval from the FDA to market and sell a new model of the product.

Ann

ounc

emen

ts –

US


Appendix

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Companies in the PwC Life Sciences IndexMed Device Closing Mcap (A$m) Quarterly return

ADO ANTEO DIAGNOSTICS LIMITED 3.24 -10%

AMT ADVANCED SURGICAL DESIGN & MANUFACTURE LIMITED 14.12 29%

AQL AQUACAROTENE LIMITED 4.27 23%

ACG ATCOR MEDICAL HOLDINGS LIMITED 17.00 -11%

ATW ATOS WELLNESS LTD 2.27 208%

AYX AUSTOFIX GROUP LIMITED 9.68 -1%

BOD BIOMD LIMITED 7.47 59%

BRC BRAIN RESOURCE COMPANY LIMITED (THE) 24.76 1.9%

BZI BRAINZ INSTRUMENTS LIMITED 1.98 106%

CBB CORDLIFE LIMITED 36.98 18%

CXD CATHRX LTD 28.07 -1%

CLV CLOVER CORPORATION LIMITED 33.04 -7%

COH COCHLEAR LIMITED 3752.76 16%

CGS COGSTATE LTD 16.08 2.1%

CMP COMPUMEDICS LIMITED 29.82 32%

CYC CYCLOPHARM LIMITED 13.00 -5%

EMS EASTLAND MEDICAL SYSTEMS LTD 22.86 97%

ELX ELLEX MEDICAL LASERS LIMITED 15.28 38%

FER FERMISCAN HOLDINGS LIMITED 9.61 -32%

HIN HEARTWARE INTERNATIONAL, INC 286.38 9%

IAT IATIA LIMITED 3.45 0%

BMI BMDI INTERNATIONAL LIMITED 8.85 14%

IPD IMPEDIMED LIMITED 71.96 3%

ITD ITL LIMITED 10.14 1%

KSX KARMELSONIX LIMITED 32.19 35%

LBT LABTECH SYSTEMS LIMITED 14.91 20%

MDG MEDTECH GLOBAL LIMITED 4.31 -9%

MOD MEDICAL CORPORATION AUSTRALASIA LIMITED 5.73 -17%

MGZ MEDIGARD LIMITED 8.85 41%

MDV MEDIVAC LIMITED 13.25 36%

NDL NEURODISCOVERY LIMITED 2.36 11%

NAN NANOSONICS LIMITED 96.31 23%

NAL NORWOOD ABBEY LIMITED 2.25 83%

OBJ OBJ LIMITED 3.52 25%

OMI OCCUPATIONAL & MEDICAL INNOVATIONS LIMITED 6.63 16%

OIL OPTISCAN IMAGING LIMITED 12.90 168%

PLT POLARTECHNICS LIMITED 18.61 13%

MVH MEDIC VISION LIMITED 4.87 0%

RMD RESMED INC 3920.77 0%

SFP SAFETY MEDICAL PRODUCTS LIMITED 3.82 -22%

SOM SOMNOMED LIMITED 23.03 30%

SHC SUNSHINE HEART, INC. 25.24 -6%

TDX TYRIAN DIAGNOSTICS LIMITED 11.45 -12%

UBI UNIVERSAL BIOSENSORS, INC. 210.43 43%

UNI UNILIFE MEDICAL SOLUTIONS LIMITED 305.50 345%

UCM USCOM LIMITED 32.00 4%

Pharma and Biotech

ACL ALCHEMIA LIMITED 91.76 60.56%

ACR ACRUX LIMITED 271.84 50.22%

ACU ACUVAX LIMITED 14.66 -20.69%

ACW ACTINOGEN LIMITED 2.79 -36.84%

AGX AGENIX LIMITED 7.41 2.35%

ALT ANALYTICA LIMITED 8.39 -9.09%

ANP ANTISENSE THERAPEUTICS LIMITED 28.54 35.14%

APH ASCENT PHARMAHEALTH LTD 58.62 80.77%

AVH AVITA MEDICAL LTD 17.07 70.00%

AVX AVEXA LIMITED 78.32 0.00%

BLT BENITEC LIMITED 16.27 84.00%

BDM BIODIEM LIMITED 13.37 124.72%

BNO BIONOMICS LIMITED 75.05 28.57%

BPH BIOPHARMICA LIMITED 11.24 581.82%

BPO BIOPROSPECT LIMITED 11.22 35.29%

BOS BIOSIGNAL LIMITED 3.00 15.00%


Med Device Closing Mcap (A$m) Quarterly return

ADO ANTEO DIAGNOSTICS LIMITED 3.24 -10%

AMT ADVANCED SURGICAL DESIGN & MANUFACTURE LIMITED 14.12 29%

AQL AQUACAROTENE LIMITED 4.27 23%

ACG ATCOR MEDICAL HOLDINGS LIMITED 17.00 -11%

ATW ATOS WELLNESS LTD 2.27 208%

AYX AUSTOFIX GROUP LIMITED 9.68 -1%

BOD BIOMD LIMITED 7.47 59%

BRC BRAIN RESOURCE COMPANY LIMITED (THE) 24.76 1.9%

BZI BRAINZ INSTRUMENTS LIMITED 1.98 106%

CBB CORDLIFE LIMITED 36.98 18%

CXD CATHRX LTD 28.07 -1%

CLV CLOVER CORPORATION LIMITED 33.04 -7%

COH COCHLEAR LIMITED 3752.76 16%

CGS COGSTATE LTD 16.08 2.1%

CMP COMPUMEDICS LIMITED 29.82 32%

CYC CYCLOPHARM LIMITED 13.00 -5%

EMS EASTLAND MEDICAL SYSTEMS LTD 22.86 97%

ELX ELLEX MEDICAL LASERS LIMITED 15.28 38%

FER FERMISCAN HOLDINGS LIMITED 9.61 -32%

HIN HEARTWARE INTERNATIONAL, INC 286.38 9%

IAT IATIA LIMITED 3.45 0%

BMI BMDI INTERNATIONAL LIMITED 8.85 14%

IPD IMPEDIMED LIMITED 71.96 3%

ITD ITL LIMITED 10.14 1%

KSX KARMELSONIX LIMITED 32.19 35%

LBT LABTECH SYSTEMS LIMITED 14.91 20%

MDG MEDTECH GLOBAL LIMITED 4.31 -9%

MOD MEDICAL CORPORATION AUSTRALASIA LIMITED 5.73 -17%

MGZ MEDIGARD LIMITED 8.85 41%

MDV MEDIVAC LIMITED 13.25 36%

NDL NEURODISCOVERY LIMITED 2.36 11%

NAN NANOSONICS LIMITED 96.31 23%

NAL NORWOOD ABBEY LIMITED 2.25 83%

OBJ OBJ LIMITED 3.52 25%

OMI OCCUPATIONAL & MEDICAL INNOVATIONS LIMITED 6.63 16%

OIL OPTISCAN IMAGING LIMITED 12.90 168%

PLT POLARTECHNICS LIMITED 18.61 13%

MVH MEDIC VISION LIMITED 4.87 0%

RMD RESMED INC 3920.77 0%

SFP SAFETY MEDICAL PRODUCTS LIMITED 3.82 -22%

SOM SOMNOMED LIMITED 23.03 30%

SHC SUNSHINE HEART, INC. 25.24 -6%

TDX TYRIAN DIAGNOSTICS LIMITED 11.45 -12%

UBI UNIVERSAL BIOSENSORS, INC. 210.43 43%

UNI UNILIFE MEDICAL SOLUTIONS LIMITED 305.50 345%

UCM USCOM LIMITED 32.00 4%

Pharma and Biotech

ACL ALCHEMIA LIMITED 91.76 60.56%

ACR ACRUX LIMITED 271.84 50.22%

ACU ACUVAX LIMITED 14.66 -20.69%

ACW ACTINOGEN LIMITED 2.79 -36.84%

AGX AGENIX LIMITED 7.41 2.35%

ALT ANALYTICA LIMITED 8.39 -9.09%

ANP ANTISENSE THERAPEUTICS LIMITED 28.54 35.14%

APH ASCENT PHARMAHEALTH LTD 58.62 80.77%

AVH AVITA MEDICAL LTD 17.07 70.00%

AVX AVEXA LIMITED 78.32 0.00%

BLT BENITEC LIMITED 16.27 84.00%

BDM BIODIEM LIMITED 13.37 124.72%

BNO BIONOMICS LIMITED 75.05 28.57%

BPH BIOPHARMICA LIMITED 11.24 581.82%

BPO BIOPROSPECT LIMITED 11.22 35.29%

BOS BIOSIGNAL LIMITED 3.00 15.00%

Med Device Closing Mcap (A$m) Quarterly return

BTA BIOTA HOLDINGS LIMITED 477.61 128.45%

BIT BIOTRON LIMITED 16.04 64.71%

BNE BONE MEDICAL LIMITED 15.45 0.00%

CST CELLESTIS LIMITED 324.49 11.92%

CXS CHEMGENEX PHARMACEUTICALS LTD 207.80 13.08%

CIR CIRCADIAN TECHNOLOGIES LIMITED 35.29 6.85%

CUV CLINUVEL PHARMACEUTICALS LIMITED 101.55 19.64%

CTE CRYOSITE LIMITED 4.20 0.00%

CSL CSL LIMITED 20011.56 4.07%

CYT CYTOPIA LIMITED 10.16 64.38%

GBI GENERA BIOSYSTEMS LIMITED 47.00 50.94%

GEN GENESIS RESEARCH AND DEVELOPMENT CORPORATION LIMITED 1.57 -4.00%

GTG GENETIC TECHNOLOGIES LIMITED 20.61 22.22%

GIA GIACONDA LIMITED 10.29 233.33%

HGN HALCYGEN PHARMACEUTICALS LIMITED 39.38 150.00%

HTX HEALTHLINX LIMITED 9.53 214.29%

HXL HEXIMA LIMITED 43.27 57.14%

HCT1 HOLISTA COLLTECH LIMITED 17.50 763.64%

IMC IMMURON LIMITED 20.29 176.92%

IMU IMUGENE LIMITED 19.39 98.53%

ICV INCITIVE LIMITED 2.88 0.00%

IDT INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LIMITED 76.17 22.92%

LCT LIVING CELL TECHNOLOGIES LIMITED 62.00 30.56%

MVP MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED 9.12 14.29%

MTY MEDICAL THERAPIES LIMITED 5.74 50.00%

MSB MESOBLAST LIMITED 140.26 24.10%

MBP METABOLIC PHARMACEUTICALS LIMITED 9.65 18.52%

NEU NEUREN PHARMACEUTICALS LIMITED 10.30 50.00%

NRT NOVOGEN LIMITED 74.55 40.38%

NSP NUSEP LIMITED 2.82 -83.00%

PAB PATRYS LIMITED 25.80 7.69%

PLI PEPLIN, INC 160.13 72.12%

PBP PROBIOTEC LIMITED 137.58 18.57%

PAA PHARMAUST LIMITED 9.17 145.00%

PXS PHARMAXIS LTD 522.96 -0.41%

POH PHOSPHAGENICS LIMITED 63.71 -28.89%

PYC PHYLOGICA LIMITED 21.58 96.43%

PBT PRANA BIOTECHNOLOGY LIMITED 54.74 88.00%

PRR PRIMA BIOMED LTD 90.56 250.00%

PCC PROBIOMICS LIMITED 3.53 71.43%

PGL PROGEN PHARMACEUTICALS LIMITED. 14.83 -27.65%

PVA PSIVIDA CORP. 90.40 146.27%

QRX QRXPHARMA LIMITED 68.63 134.62%

RBY ROCKEBY BIOMED LIMITED 2.32 24.00%

SIE SCIGEN LIMITED 66.27 -35.00%

SLT SELECT VACCINES LIMITED 1.02 33.33%

SRX SIRTEX MEDICAL LIMITED 269.92 44.48%

SLA SOLAGRAN LIMITED 43.86 74.16%

SPL STARPHARMA HOLDINGS LIMITED 118.11 67.65%

STI STIRLING PRODUCTS LIMITED 6.33 -35.71%

TEO TELESSO TECHNOLOGIES LIMITED 2.41 3.13%

TIS TISSUE THERAPIES LIMITED 16.02 28.13%

VLA VIRALYTICS LIMITED 9.57 -9.09%

VHL VIRAX HOLDINGS LIMITED 9.40 105.71%

XCD XCEED CAPITAL LTD 2.60 30.00%

1 COLLTECH AUSTRALIA (CAU) - changed its name to Holista Colltech (HCT)2 AVASTRA SLEEP CENTRES LIMITED (AVS) - suspended from the index3 ARANA THERAPEUTICS LIMITED (AAH) - removed from the index4 VENTRACOR LIMITED (VCR) - removed from the index

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SourcesBioForum draws on historical data from the following sources:

Bloomberg

Connect 4

the ASX

company websites

PwC Global Pharma and Life Science Quarterly Newsbriefs

Market performanceThe Australian life sciences sector’s market performance is tracked through two indices:

i) PwC Life Sciences Index

ii) PwC Life Sciences Index ex majors (CSL, ResMed and Cochlear)

Analysis is provided without the large-capitalisation stocks (majors) so the performance of smaller-capitalisation stocks can be observed.

The PwC Life Sciences Index is based on the performance of life sciences companies listed on the Australian Securities Exchange (ASX). It comprises two subsectors:

i) pharmaceutical/biotechnology

ii) medical devices

These sectors have been classified according to the Global Industry Classification Standard. The index includes life sciences companies primarily involved in research, development, commercialisation and manufacturing of pharmaceutical and biotechnology products and medical devices. It excludes healthcare, medical software and distribution companies. Companies included in the PwC Life Sciences Index are listed at the end of each issue of BioForum.

The PwC Life Sciences Index is based on the combined market capitalisation of the listed companies and calculates the change of their value over the quarter and change over the previous year. These changes are compared to the changes in the market performance of the following indices:

ASX All Ordinaries

NASDAQ Composite

NASDAQ Biotech

•

•

•

•

•

•

•

•

Different formulae are used to calculate the value of these indices and track their performance. These formulae use a combination of company market prices and a weighted average of market capitalisation. Because of these different methods of calculating value, the absolute value of the indices cannot be directly compared. Only their changes over time can be sensibly compared.

Top and bottom performersAnnual data on these companies is sourced from Bloomberg each quarter. Company announcements are sourced from the ASX or directly from company websites.

IPO and secondary finance marketsIPO and secondary financing data is sourced from the Connect 4 database’s health-care industry category. We include data from companies on the PwC Life Sciences Index only. Data on options, rights and bonus issues is excluded.

The US IPO and secondary financing data is sourced from our quarterly PwC Global Pharma and Life Sciences Newsbrief.

AnnouncementsThese are from companies listed on the PwC Life Sciences Index only. They are sourced from Connect 4 using the health-care industry category. We include announcements on partnerships, mergers and acquisitions and divestments, clinical results, regulatory activity and other information. Examples of other information include management and board changes, the closing or opening of offices, and successful grant applications.

Announcements on the following are excluded:

trading halts

capital raisings

proposed (versus actual) mergers, acquisitions and partnerships

progress reports on clinical trials (results only are included)

market registration approval

The US announcement data is sourced from our quarterly PwC Global Pharma and Life Sciences Newsbrief.

•

•

•

•

•

Methodology


AcknowledgementsWritten and edited by:

PricewaterhouseCoopers (www.pwcglobal.com), a global professional services organisation serving the life sciences sector and other industries.

External contributors:

Dr William Dolphin, CEO, Avita Medical Limited

PwC Global Pharmaceutical Team

Quantitative research and analysis by the PricewaterhouseCoopers BioForum team:

Tony Gellert, Manager, Principal Author

Calvin Lim, Senior Consultant

Joe Adendorff, Consultant

Angelique Fitzgerald, Consultant

Chamindu Balasuriya, Undergraduate Consultant

PwC Life Sciences Practice contributors PricewaterhouseCoopers – Life Sciences Practice

Craig Lawn, Partner, National Life Science Industry Leader

Manoj Santiago, Partner, Sydney Life Science Industry Leader

Adrian Bunter, Director

Stephanie Wood, Administration

External

Karen Hunt, Editor and proof readerA

pp

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This document is provided by PricewaterhouseCoopers as general guidance only and does not constitute the provision of legal advice, tax services, investment advice or professional consulting of any kind. The information provided herein should not be used as a substitute for consultation with professional tax, accounting, legal or other competent advisers. The application and impact of laws can vary widely based on the specific facts involved. Given the changing nature of laws, rules and regulations, there may be omissions or inaccuracies in the information presented herein. Before making any decision or taking any action, you should consult a professional adviser who has been provided with all the pertinent facts relevant to your particular situation.

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