KAPIDEX - Gene€¦ · new business opportunities for licensing or partnerships and analyze...

Launches

GRAZAX

ALK-Abello UK launch for use in

children and adolescents

On 23 February 2009 ALK-Abello

announced that GRAZAX has been

launched in the UK for use in children

and adolescents (aged five to 17 years)

with severe grass pollen-induced

seasonal a l lerg ic rhin it is and

conjunctivitis or severe hay fever.

GRAZAX, a once-daily tablet-based

immunotherapy, was approved in the

EU in September 2006 for the

treatment of adults with grass pollen

allergy, and has subsequently been

launched for this indication in

Germany, the UK, Denmark, Norway,

Sweden and Ireland.

quetiapine

AstraZeneca launches

extended-release formulation for

additional indications

AstraZeneca announced on 23 February

2009 that it has launched once-daily

quetiapine extended-release tablets

(SEROQUEL XR) in the USA for the acute

treatment of depressive episodes

associated with bipolar disorder, manic

and mixed episodes associated with

bipolar I disorder, and as maintenance

therapy for bipolar I disorder as an

adjunct to lithium or divalproex. The

KAPIDEXTakeda marketed, USA (GERD)

On 23 February 2009 Takeda reported that it has launched KAPIDEX (30

and 60 mg capsules) in the USA for the treatment of heartburn

associated with symptomatic non-erosive gastroesophageal reflux

disease (GERD), the healing of erosive esophagitis (EE) and the

maintenance of healed EE. KAPIDEX is a modified-release formulation

of the proton pump inhibitor dexlansoprazole, an enantiomer of

lansoprazole.

APPROVALS

EFIENT & FIRMAGON Approved

in the EU

REMOVAB & CONBRIZA

Recommended for Approval in

the EU

ONRIGIN Submitted for

Approval in the USA

LICENSING

Agreements between

NeuroSearch & Lilly, Chugai &

Romark, Neopharm Ltd &

Orexo, Bial & Eisai, Abbott &

Sucampo, Access & Dong-A,

Actelion & GeneraMedix, CSL &

Xencor

TECHNOLOGY TRANSFERSPOTLIGHT

German Cancer Research Center

PIPELINE NEWS

CNSBio

Shire

PRODUCTS &BIOTECHNOLOGY

Albiglutide Enters PIII

AV 951, EC 145, TB 402 & SGN

35 Enter PII

NKTR 105, DM 1992, ABT 450

and GTx 758 Enter PI

Resatorvid Discontinued

COMPANY FOCUS

Gene Signal International

TABLES

Newly reported drugs

Product phase changes

Volume 18 No 9

2 March 2009

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2

CON TENTSLAUNCHES 1

GRAZAX · · · · · · · · · · · · · · · · · · · · · · · · · · 1quetiapine · · · · · · · · · · · · · · · · · · · · · · · · · 1

AP PROV ALS 4

prasugrel · · · · · · · · · · · · · · · · · · · · · · · · · 4degarelix · · · · · · · · · · · · · · · · · · · · · · · · · 4catumaxomab· · · · · · · · · · · · · · · · · · · · · · · · 4bazedoxifene · · · · · · · · · · · · · · · · · · · · · · · · 4laromustine · · · · · · · · · · · · · · · · · · · · · · · · 4CIP-Tramadol ER · · · · · · · · · · · · · · · · · · · · · · · 5vorinostat · · · · · · · · · · · · · · · · · · · · · · · · · 5drug delivery system, inhaled aztreonam, Gilead Sciences · · · · · · · 5valsartan + amlodipine + hydrochlorothiazide · · · · · · · · · · · · 5efalizumab · · · · · · · · · · · · · · · · · · · · · · · · · 5drug delivery system, topical diclofenac, Nuvo· · · · · · · · · · · · 5BIFERONEX · · · · · · · · · · · · · · · · · · · · · · · · · 6

LI CENS ING 6

ion channel modulators, NeuroSearch/Lilly · · · · · · · · · · · · · 6nitazoxanide · · · · · · · · · · · · · · · · · · · · · · · · 6ABSTRAL · · · · · · · · · · · · · · · · · · · · · · · · · 7eslicarbazepine acetate · · · · · · · · · · · · · · · · · · · · 7lubiprostone · · · · · · · · · · · · · · · · · · · · · · · · 7ProLindac · · · · · · · · · · · · · · · · · · · · · · · · · 7cancer therapy, Stockbridge Pharmaceuticals · · · · · · · · · · · · 8caerulomycin A · · · · · · · · · · · · · · · · · · · · · · · 8drug delivery system, thermostable epoprostenol, Actelion · · · · · · · 8XmAb · · · · · · · · · · · · · · · · · · · · · · · · · · · 8cannabinoid-2 receptor agonists, Reperio · · · · · · · · · · · · · 8drug discovery, HUYA/Beijing Institute of Materia Medica · · · · · · · 9ibritumomab tiuxetan · · · · · · · · · · · · · · · · · · · · · 9MEDUSA · · · · · · · · · · · · · · · · · · · · · · · · · · 9

TECH NOL OGY TRANS FER SPOT LIGHT 9

fusion polypeptides, German Cancer Research Center · · · · · · · · · 9parvovirus NS1 variants, German Cancer Research Center · · · · · · · 10parvovirus H-1 protein, German Cancer Research Center · · · · · · · · 10NS1 protein/VP1 capsid protein, German Cancer Research Center · · · · 10

PIPE LINE NEWS 11

CNSB001 · · · · · · · · · · · · · · · · · · · · · · · · · 11CNSB004 · · · · · · · · · · · · · · · · · · · · · · · · · 11CNSB006 · · · · · · · · · · · · · · · · · · · · · · · · · 11lanthanum carbonate · · · · · · · · · · · · · · · · · · · · 13HGT 2610 · · · · · · · · · · · · · · · · · · · · · · · · · 13SPD 503 · · · · · · · · · · · · · · · · · · · · · · · · · 13icatibant · · · · · · · · · · · · · · · · · · · · · · · · · 13

PROD UCTS & BIO TECH NOL OGY 13

resatorvid· · · · · · · · · · · · · · · · · · · · · · · · · 13NS 2359 · · · · · · · · · · · · · · · · · · · · · · · · · 13albiglutide · · · · · · · · · · · · · · · · · · · · · · · · 14aliskiren + amlodipine + hydrochlorothiazide · · · · · · · · · · · · 14vaccine, Clostridium difficile, Sanofi Pasteur · · · · · · · · · · · · 14nicotinic acid receptor agonist, Merck & Co/Arena · · · · · · · · · · 14AV 951· · · · · · · · · · · · · · · · · · · · · · · · · · 14EC 145 · · · · · · · · · · · · · · · · · · · · · · · · · · 15vaccine, gene-based, HIV infection, GeoVax · · · · · · · · · · · · 15TB 402 · · · · · · · · · · · · · · · · · · · · · · · · · · 15SGN 35· · · · · · · · · · · · · · · · · · · · · · · · · · 15NKTR 105 · · · · · · · · · · · · · · · · · · · · · · · · · 16DM 1992 · · · · · · · · · · · · · · · · · · · · · · · · · 16ABT 450 · · · · · · · · · · · · · · · · · · · · · · · · · 16LX 214 · · · · · · · · · · · · · · · · · · · · · · · · · · 16CB 182804 · · · · · · · · · · · · · · · · · · · · · · · · 16MVA-BN-HER2 · · · · · · · · · · · · · · · · · · · · · · · 16GTx 758 · · · · · · · · · · · · · · · · · · · · · · · · · 17nabiximols · · · · · · · · · · · · · · · · · · · · · · · · 17VGX 3400 · · · · · · · · · · · · · · · · · · · · · · · · · 17mifepristone· · · · · · · · · · · · · · · · · · · · · · · · 17PENNVAX-B & PENNVAX-GP · · · · · · · · · · · · · · · · · · 18ondansetron· · · · · · · · · · · · · · · · · · · · · · · · 18AN 2728 · · · · · · · · · · · · · · · · · · · · · · · · · 18vaccine, NSCLC, Transgene · · · · · · · · · · · · · · · · · · 19Genz 112638 · · · · · · · · · · · · · · · · · · · · · · · 19NPL 2008 · · · · · · · · · · · · · · · · · · · · · · · · · 19rosuvastatin · · · · · · · · · · · · · · · · · · · · · · · · 20UDB · · · · · · · · · · · · · · · · · · · · · · · · · · · 20ALKS 27 · · · · · · · · · · · · · · · · · · · · · · · · · 20ChimeriVax-Dengue · · · · · · · · · · · · · · · · · · · · · 20riociguat · · · · · · · · · · · · · · · · · · · · · · · · · 21MAb, VAP-1, BioTie Therapies · · · · · · · · · · · · · · · · · 21Q 8003IR · · · · · · · · · · · · · · · · · · · · · · · · · 21IPI 940 · · · · · · · · · · · · · · · · · · · · · · · · · 21vaccine, cat allergy, Alk-Abello · · · · · · · · · · · · · · · · · 21

COM PANY FO CUS 23

GS 102 · · · · · · · · · · · · · · · · · · · · · · · · · · 23GS 101 · · · · · · · · · · · · · · · · · · · · · · · · · · 23GS 156 · · · · · · · · · · · · · · · · · · · · · · · · · · 24GS 168 · · · · · · · · · · · · · · · · · · · · · · · · · · 24GS 497c · · · · · · · · · · · · · · · · · · · · · · · · · 24GS 326 · · · · · · · · · · · · · · · · · · · · · · · · · · 24

NEWLY RE PORTED DRUGS IN R&D FO CUS 25

PROD UCT PHASE CHANGES RE PORTED IN R&D FO CUS 27

IMS HEALTH R&D FO CUS drugnews 2 March 2009

See R&Dfocus (Drug Up dates) for full prod uct de tails 3

© 2009 IMS Health In cor po rated or its af fil i ates. All rights re served.

agent was approved for these indications by the US FDA in

October 2008. Quetiapine is available worldwide as a

treatment for schizophrenia.

Approvals

prasugrel

Daiichi Sankyo, Lilly registered, EU (acute coronary

syndrome)

On 23 February 2009 Daiichi Sankyo and Lilly announced that

the European Commission has granted marketing approval to

prasugrel (EFIENT) for the prevention of atherothrombotic

events in patients with acute coronary syndrome (ACS)

undergoing percutaneous coronary intervention (PCI); this

follows a recommendation by the EMEA’s CHMP in December

2008.

Prasugrel, an oral antithrombotic prodrug that inhibits the

ADP receptor, is awaiting marketing approval from the US

FDA for the treatment of patients with ACS managed with PCI.

degarelix

Ferring registered, EU (prostate cancer)

Ferring announced on 19 February 2009 that the European

Commission has granted marketing approval to degarelix

(FIRMAGON), a synthetic gonadotropin-releasing hormone

(GnRH) antagonist, for the treatment of patients with

advanced, hormone-dependent prostate cancer. Phase III

trial data showed that degarelix treatment produced a rapid

and significant reduction in testosterone levels in more than

96% of patients. The agent was approved in the USA for the

treatment of prostate cancer in December 2008.

catumaxomab

Fresenius recommended for approval, EU (cancer)

Fresenius announced on 18 February 2009 that the CHMP of

the EMEA has issued a positive opinion recommending

catumaxomab (REMOVAB) for approval in the intraperitoneal

treatment of malignant ascites. The CHMP’s positive opinion

is based on results from an international phase II/III pivotal

study, which demonstrated a four-fold increase in puncture

free survival over a therapy consisting of puncture alone.

Approval by the European Commission is expected during

second quarter 2009.

bazedoxifene

Wyeth recommended for approval, EU

(osteoporosis)

Wyeth announced on 19 February 2009 that the EMEA’s CHMP

has adopted a positive opinion recommending approval of a

marketing authorization application for bazedoxifene

(CONBRIZA) for the treatment of postmenopausal

osteoporosis in women at increased risk of fracture. Data

from two multicenter, randomized, double-blind,

placebo-controlled phase III trials of bazedoxifene in more

than 9000 postmenopausal women suggested a favorable

endometrial profile for the agent and confirmed its selective

estrogen receptor modulator (SERM) characteristics.

Thromboembolic events were the most serious adverse

reactions reported and were more common with bazedoxifene

treatment than with placebo.

Wyeth is developing bazedoxifene, a once-daily oral SERM,

for the treatment and prevention of postmenopausal

osteoporosis. The agent is also pending approval in the USA

and Japan.

laromustine

Vion submitted for approval, USA (AML)

Vion reported on 17 February 2009 that it has filed an NDA

with the US FDA for laromustine (ONRIGIN) injection as a

monotherapy for remission induction in patients aged 60 or

older with de novo poor-risk acute myelogenous leukemia

(AML). The filing was based on data from an ongoing pivotal

phase II trial of the agent in 85 AML patients aged 65 years

and a previous phase II trial in elderly AML patients. Vion has

requested Priority Review of the submission.

Laromustine, a sulfonyl hydrazine alkylating, is also being

evaluated in a phase III trial in combination with standard

remission induction therapy in patients with AML and

myelodysplastic syndromes, a phase I/II trial in combination

with cytarabine in elderly AML patients and a phase I/II trial

in combination with temozolomide in the treatment of brain

tumors.

2 March 2009 R&D FO CUS drugnews IMS HEALTH

4 See IMS LifeCycle, R&Dfocus for full prod uct de tails


CIP-Tramadol ER

Cipher receives tentative approval from US FDA

On 17 February 2009 Cipher announced that the US FDA has

granted tentative approval for CIP-Tramadol ER, an orally

administered, once-daily extended-release formulation of

tramadol, for the management of moderate to moderately

severe chronic pain. The agency stipulated that patent issues

relating to the reference product, ULTRAM ER, need to be

resolved before CIP-Tramadol ER can be marketed.

vorinostat

Merck & Co withdraws MAA

On 17 February 2009 Merck Sharp & Dohme, a Merck & Co

company, notified the EMEA of a decision to withdraw its

MAA, seeking centralized EU approval for vorinostat

(ZOLINZA) as a therapy for patients with advanced stage

cutaneous T-cell lymphoma (CTCL) who have progressive,

persistent or recurrent disease, and who have failed at least

two previous systemic therapies. The decision to withdraw

the application was based on a CHMP opinion that the data

provided were insufficient to grant marketing authorization.

Vorinostat, a histone deacetylase (HDAC) inhibitor, is

marketed in the USA for this indication.

drug delivery system, inhaled

aztreonam, Gilead Sciences

Gilead Sciences receives US FDA response to appeal

Gilead Sciences announced on 19 February 2009 that,

following its appeal (submitted under the formal dispute

resolution process in November 2008) regarding the US FDA’s

Complete Response letter to its NDA for aztreonam for

inhalation, the US FDA has restated its position, including

the need for an additional clinical trial to be conducted prior

to an NDA resubmission. Gilead Sciences plans to discuss

whether ongoing trials will meet this requirement.

Gilead Sciences is developing inhaled aztreonam for the

treatment of Gram negative bacterial infections in patients

with cystic fibrosis; the formulation is being developed using

PARI’s proprietary eFLOW Electronic Nebulizer. The agent is

also undergoing regulatory review in Canada and the EU.

valsartan + amlodipine +

hydrochlorothiazide

Novartis anticipates US approval

Novartis reported in a presentation of its Financial Results

2008, on 28 January 2009, that it expects to receive US

marketing approval for a combination of valsartan (an

angiotensin II receptor antagonist), amlodipine (a calcium

channel blocker), and hydrochlorothiazide (a diuretic),

during 2009. The combination therapy was submitted for

approval for the treatment of hypertension.

efalizumab

Merck Serono receives notification of EMEA and

Health Canada recommendations

Merck Serono announced on 19 February 2009 that the EMEA

has recommended to the European Commission the

suspension of Merck Serono’s MAA for efalizumab (RAPTIVA).

This follows three cases of progressive multifocal

leukoencephalopathy in psoriasis patients treated with the

agent since October 2008. The CHMP of the EMEA concluded

that the benefits of efalizumab no longer outweigh its risks.

Merck Serono will discuss next steps with the EMEA, and

health authorities outside the EU will be informed of the

EMEA recommendation. On 23 February 2009, Health Canada

recommended the suspension of the agent in Canada; EMD

Serono Canada, the Canadian affiliate of Merck Serono, will

suspend efalizumab. No new prescriptions will be issued and

the agent will no longer be available in Canada within a few

months.

Efalizumab, an anti-CD11a monoclonal antibody, has been

widely marketed in the EU as a therapy for adults with

moderate-to-severe plaque psoriasis since its approval in

2004. The agent is also marketed in several other countries,

including the USA and Australia for this indication.

drug delivery system, topical

diclofenac, Nuvo

Nuvo resubmits application for US marketing

approval

On 19 February 2009 Nuvo announced that it has resubmitted

an application for US approval of PENNSAID, a topical




non-steroidal anti-inflammatory drug under development for

the relief of pain and stiffness associated with osteoarthritis.

The resubmission was accepted as a complete response to an

Approvable Letter issued by the US FDA in December 2006.

The US FDA has set a PDUFA date of 5 August 2009. PENNSAID

is available in Canada and several European Markets,

including the UK and Italy, for the treatment of

osteoarthritis.

BIFERONEX

Biopartners to appeal CHMP negative opinion

Following a negative opinion issued by the CHMP of the

EMEA, recommending the refusal of EU approval for

BIFERONEX, Biopartners announced on 19 February 2009 that

it will request a re-evaluation of the negative opinion. The

appeal is expected to last until June 2009.

In August 2007, Biopartners filed an MAA with the EMEA for

BIFERONEX, a recombinant interferon beta-1a, for the

treatment of relapsing remitting multiple sclerosis. The

product is a pH neutral and human serum albumin-free

formulation.

Licensing

ion channel modulators,

NeuroSearch/Lilly

Lilly, NeuroSearch licensing agreement

NeuroSearch announced on 17 February 2009 that it has

signed a collaborative agreement with Lilly relating to the

discovery and development of ion channel modulators for the

treatment of central nervous system disorders. Intellectual

property and know-how from both companies will be used to

develop these agents. Under the terms of the three-year

agreement, drug discovery will be conducted by NeuroSearch;

preclinical development of candidate drugs may also be

carried out by NeuroSearch. Individual agents covered by the

agreement (and related intellectual property) may be

licensed by Lilly by exercising various options. Once the

option has been exercised, Lilly will be responsible for all

development and commercialization. NeuroSearch will

receive a US$5 million upfront payment from Lilly, and an

additional US$8 million in research funding over the next

three years. Lilly will make a US$17 million equity investment

in NeuroSearch. NeuroSearch may receive milestone

payments of up to US$320 million plus royalties on worldwide

sales for each product successfully developed and

commercialized.

nitazoxanide

Chugai, Romark licensing agreement

Romark clinical data (hepatitis C)

Romark has signed a licensing agreement with Chugai, under

which Chugai acquires exclusive Japanese rights to develop

and commercialize nitazoxanide for the treatment of chronic

hepatitis C virus (HCV) infection. Under the terms of the

agreement, announced on 17 February 2009, Romark has

received an undisclosed upfront payment from Chugai, and

wil l be eligible to receive further cl inical- and

regulatory-based milestone payments. Romark will be

entitled to a share of profits from Japanese sales of

nitazoxanide through a supply agreement and royalties.

On 17 February 2009 Romark reported results from a phase I

and a phase II trial of a controlled-release formulation of

nitazoxanide in the treatment of HCV infection. Results from

a randomized, double-blind, crossover phase I trial (OPTIMA

HCN-1) showed that controlled-release nitazoxanide,

administered at 675 mg or 1350 mg bid po with food for seven

days, resulted in trough plasma concentrations of active

metabolite (tizoxanide) that were about three-fold and

12-fold the trough plasma concentrations observed in

previous trials using a standard nitazoxanide 500 mg tablet.

The agent was well tolerated with mild gastrointestinal side

effects reported. Data from the OPTIMA HCN-2 phase II trial,

involving 41 treatment-naive HCV genotype 4 infected

patients, showed that 82% and 100% of patients receiving

the low-dose and high-dose controlled-release nitazoxanide,

respectively, had undetectable serum HCV RNA after 12 weeks

of combination therapy with peginterferon alfa-2a and

ribavirin. Romark expects to report interim results from US

trials of the standard nitazoxanide tablet in patients with

chronic HCV genotype 1 infection during 2009.

Nitazoxanide, a thiazolide, is available in several markets

including Mexico, for the treatment of parasitic infections

and cryptosporidiosis in AIDS patients. Nitazoxanide

(ALINIA) is also marketed in the USA for the treatment of




diarrhea caused by Cryptosporidium parvum and Giardia

lamblia.

ABSTRAL

Neopharm Ltd, Orexo licensing agreement

On 18 February 2009 Orexo announced that it has entered

into an exclusive distribution agreement with Neopharm Ltd,

under which Neopharm Ltd has been granted the marketing

and sales rights to ABSTRAL in Israel for the treatment of

breakthrough cancer pain. Orexo will provide Neopharm Ltd

with the product in return for significant margins on the

sales. Neopharm Ltd will assume responsibility for the

regulatory approval process in Israel. Orexo is eligible to

receive milestone payments from Neopharm Ltd; financial

details of the agreement were not disclosed.

ABSTRAL, a sublingual mucoadhesive formulation of

fentanyl, was first launched in Sweden in August 2008 for the

treatment of breakthrough cancer pain. The agent was

subsequently launched for the same indication in the UK and

Germany in January 2009.

eslicarbazepine acetate

Bial, Eisai licensing agreement

Bial recommended for approval, EU (epilepsy)

Bial has signed an agreement with Eisai, granting Eisai

exclusive rights to market, promote and distribute

eslicarbazepine acetate (ZEBINIX) in Europe. Under the terms

of the agreement, announced on 19 February 2009,

development and production of the agent will be Bial’s

responsibility. Bial will supply the finished product to Eisai

and will also have an option to co-promote eslicarbazepine

acetate with Eisai in Europe. Upfront payments and milestone

payments for additional epilepsy approvals within Europe

worth EUR95 million will be paid to Bial.

On 19 February 2009, the CHMP of the EMEA issued a positive

opinion, recommending the EU approval of eslicarbazepine

acetate as adjunctive therapy in adults with partial-onset

seizures, with or without secondary generalization.

Eslicarbazepine acetate, an oral, once-daily sodium channel

blocker, is expected to receive EU approval during second

quarter 2009.

lubiprostone

Abbott, Sucampo licensing agreement

Sucampo announced on 19 February 2009 that it has entered

into a license agreement with Abbott, under which Abbott

has been granted exclusive rights to commercialize

lubiprostone (AMITIZA) in Japan for the treatment of chronic

idiopathic constipation (CIC). Abbott will assume

responsibility for all marketing expenses and efforts, and will

have the option of first refusal to any additional indications

for which the agent is developed in Japan. Sucampo will

receive an upfront payment of US$10 million from Abbott,

and is also eligible to receive certain specified development

and commercialization milestone payments. Sucampo will

continue to have responsibility for development of

lubiprostone and the regulatory process in Japan, and for all

development costs for the agent. Following marketing

authorization and pricing approval, Abbott will purchase

lubiprostone from Sucampo for distribution in Japan.

Sucampo will retain the right to co-promote the agent in

Japan. In addition, the two companies have agreed to begin

negotiations for a license, commercialization and supply

agreement for lubiprostone in other available territories.

Lubiprostone, a functional fatty acid chloride channel

opener, is available in the USA for the treatment of CIC in

adults and irritable bowel syndrome with constipation in

adult women. The agent is pending approval in several EU

countries for CIC.

ProLindac

Access, Dong-A licensing agreement

On 19 February 2009 Access and JCOM, an affiliate of Dong-A,

announced that they have entered into a definitive licensing

agreement under which JCOM and Dong-A have been granted

the rights to manufacture, develop and commercialize

ProLindac in South Korea. Under the terms of the agreement,

Access will receive an upfront fee and subsequent milestone

payments from JCOM, in addition to a double-digit royalty

upon commercialization of Prolindac. In cooperation with

Access, JCOM has agreed to fund and conduct a phase II

combination trial of the agent in an indication to be

determined by the companies; this study could cost up to

US$10 million. Dong-A will assume responsibility for

obtaining regulatory approval and for commercialization of

ProLindac in South Korea.




ProLindac, a DACH-platinum prodrug, is undergoing phase II

evaluation for the treatment of ovarian cancer and phase I

evaluation for head and neck cancer.

cancer therapy, Stockbridge

Pharmaceuticals

Columbia University, Stockbridge Pharmaceuticals

licensing agreement

On 20 February 2009 Science & Technology Ventures, the

technology transfer office at Columbia University (USA),

announced that it has signed an agreement with spin-out

company Stockbridge Pharmaceuticals for the development

of a small molecule-based approach for the treatment of

cancer. The small molecules target a protein receptor

involved in a cell signaling pathway that inhibits

programmed cell death, including cancerous cells.

Significant shrinkage of tumor mass was induced by the

therapy in a mouse model of basal-like breast cancer tumors.

The therapy was developed in collaboration with the

University of Nebraska (USA).

caerulomycin A

Institute of Microbial Technology, Nostrum

licensing agreement

Nostrum reported on 23 February 2009 that it has acquired

worldwide development and commercialization rights to

caerulomycin A, and its proprietary derivatives and

analogues for use in immunosuppression, from the Institute

of Microbial Technology (IMTECH;India). In preclinical

studies, the caeru lomycins demonstrated

immunosuppression of both T- and B-cells in in-vitro and in

rodent models. There were no toxic effects in rodents. The

caerulomycins have potential use in the prevention of organ

transplant rejection and in the treatment of autoimmune

diseases and other indications.

drug delivery system, thermostable

epoprostenol, Actelion

Actelion, GeneraMedix licensing agreement

Actelion announced on 23 February 2009 that it has signed

an agreement with GeneraMedix relating to a thermostable,

intravenous formulation of epoprostenol for the treatment of

pulmonary hypertension. Under the terms of the agreement,

Actelion acquires rights to develop, register and

commercia l i ze the thermostable formulat ion of

epoprostenol, worldwide. Financial details were not

disclosed.

The agent, which is stable at room temperature for up to 24 h,

was approved by the US FDA on 27 June 2008 for the

long-term treatment of primary pulmonary hypertension and

pulmonary hypertension associated with the scleroderma

spectrum of the disease in NYHA class III and class IV

patients who have not responded adequately to standard

therapy.

XmAb

CSL, Xencor licensing agreement

Xencor and CSL have entered into an antibody optimization

collaboration. Under the terms of the agreement, announced

on 23 February 2009, CSL will have access to Xencor’s XmAb

technology platform to enhance the ADCC effector function

of its antibodies. CSL has received several commercial

licenses allowing products that utilize Xencor’s XmAb

technology to be developed and commercialized. Xenocor will

be eligible to receive milestone payments and product

royalt ies for any products f rom this agreement

commercialized by CSL.

XmAb technology utilizes Xencor’s Protein Design

Automation (PDA) technology to generate antibodies

containing engineered Fc regions with increased binding

affinity for the Fc gamma receptors that mediate the immune

system’s cytotoxic effector functions.

cannabinoid-2 receptor agonists,

Reperio

Pharmos, Reperio sign asset purchase agreement

Pharmos announced on 18 February 2009 that it has signed

an asset purchase agreement with Reperio, under which

Pharmos has sold certain cannabinoid-2 (CB2) receptor

agonists to Reperio. Under the terms of the agreement, which

is expected to close on or before 6 June 2009, Reperio

acquires patent rights and technical know-how to PRS

639058 and certain follow-on agents. Pharmos will be




awarded an equity ownership in Reperio. Pharmos will also be

entitled to receive license and royalty fees.

The agents have been evaluated in preclinical studies for

neuropathic pain; the CB2 agonists may also be useful as

analgesic, neuroprotective, immunomodulatory and

anti-inflammatory agents.

drug discovery, HUYA/Beijing

Institute of Materia Medica

Beijing Institute of Materia Medica, HUYA

collaborate on preclinical and clinical studies

Beijing Institute of Materia Medica, HUYA sign

option agreement

HUYA announced on 18 February 2009 that it has signed a

collaborative agreement with the Beijing Institute of Materia

Medica, Chinese Academy of Medical Sciences and Peking

Union Medical College (China) (known collectively as Beijing

Institute of Materia Medica;BIMM), under which HUYA

acquires the right of first review and negotiation for the

licensing and development of certain BIMM compounds with

therapeutic potential in the areas of cardiology,

endocrinology, oncology, immunology, hematology,

neuroscience and anti-infectives. HUYA and BIMM will jointly

conduct preclinical and clinical testing. Further details of the

agreement were not disclosed.

ibritumomab tiuxetan

Cell Therapeutics, Spectrum option exercised

Cell Therapeutics reported on 20 February 2009 that it has

exercised an option to sell its 50% ownership interest in its

joint venture with Spectrum to develop and commercialize

ibritumomab tiuxetan (ZEVALIN) in the USA, to Spectrum. At

the closing of this sale, Spectrum will pay US$6 million to Cell

Therapeutics; the remainder of the US$18 million sale price

will be paid within 90 days of closing of this sale option

transaction. The joint venture was established in December

2008; Spectrum purchased a 50% membership interest in the

venture for US$15 million and various milestone payments.

Ibritumomab tiuxetan, an anti-CD20 monoclonal antibody

conjugated to yttrium-90, is available in the USA for the

treatment of relapsed or refractory low grade, follicular or

transformed B-cell non-Hodgkin’s lymphoma.

MEDUSA

Flamel Technologies, Merck Serono licensing

agreement modified

Flamel Technologies, Merck Serono milestone

payment

Flamel Technologies announced on 17 February 2009 that it

has entered into a full license agreement with Merck Serono

for the use of Flamel Technologies’ MEDUSA nanoparticle

delivery system in the extended-release delivery of an

already-marketed therapeutic protein; Merck Serono has

exercised its option, under an agreement signed in 2007, to

pursue a partnership with Flamel Technologies. Flamel

Technologies will receive a milestone payment of EUR5

million for the exercise of this option and is eligible to

receive further payments based on research and development

milestones. Research and development activities will be

funded by Merck Serono. Further terms of the agreement were

not disclosed.

Flamel Technologies’ MEDUSA is a self-assembled

poly-aminoacid nanoparticle system which acts as a carrier

for the development of long-acting formulations of peptides,

proteins and other large molecules.

Technology Transfer Spotlight

Opportunities with German

Cancer Research Center

fusion polypeptides, German


German Cancer Research Center partnering

opportunity, Worldwide

Researchers at the German Cancer Research Center (Germany)

are developing fusion polypeptides with potential utility as

cancer therapeutics. The fusion polypeptides consist of an

effector protein, or a binding site thereof, with a targeting

sequence, resulting in targeted cytotoxicity towards tumor

cells. Discovery stage evaluations are ongoing in Germany.

The fusion polypeptides are available for partnering or

licensing, worldwide.




For further information on the partnering opportunities

available, contact:

Christine Amshoff


Technologietransfer T010

Im Neuenheimer Feld 280

69120 Heidelberg

Germany

Tel: +49 6221 422950

Fax: +49 6221 422956


parvovirus NS1 variants, German




The German Cancer Research Center’s (Germany) parvovirus

NS1 protein variants, in which the equilibrium between

replication and transcription activities and cytotoxic activity

has been shifted, are available for worldwide licensing or

partnering. Preclinical evaluation of the variants, which have

potential in the treatment of cancer, is ongoing in Germany.


available, contact:

Christine Amshoff




69120 Heidelberg

Germany

Tel: +49 6221 422950

Fax: +49 6221 422956


parvovirus H-1 protein, German




Researchers at the German Cancer Research Center (Germany)

are developing the oncolytic parvovirus H-1 protein for the

potential treatment of brain tumors, particularly

glioblastoma. The parvovirus H-1 protein effectively killed

tumor cells in mouse rat and human glioma cell lines. In

addition, parvovirus H-1 did not elicit inflammatory

responses or tissue damage following intracerebral injection

in healthy rats; however, effective antitumor responses were

observed following injection of the H-1 virus in residing

intracerebral gliomas of rats with brain tumors. Preclinical

studies are ongoing in Germany. The parvovirus H-1 protein is

available for licensing or partnering, worldwide.


available, contact:

Christine Amshoff




69120 Heidelberg

Germany

Tel: +49 6221 422950

Fax: +49 6221 422956


NS1 protein/VP1 capsid protein,




The German Cancer Research Center’s (Germany) toxin

comprising two parvoviral products, the NS1 protein and part

of the capsid VP1 protein, is available worldwide for

partnering or licensing. The toxin has potential in the

treatment of glioblastomas. Preclinical evaluation is ongoing

in Germany. The intrinsic cytotoxicity of NS1, as measured by

the disappearance of VP1/NS1 containing cells as a function

of time, was significantly increased by the presence of the

VP1 variant. An induction of cytolysis, as demonstrated by

the release of lactate dehydrogenase, was apparent in the

presence of wild-type NS1 and the VP1 specific region (this

was absent upon sole expression of NS1).


available, contact:

Christine Amshoff




69120 Heidelberg




Germany

Tel: +49 6221 422950

Fax: +49 6221 422956


Pipeline News

Offers from CNSBio

CNSB001

CNSBio partnering opportunity, Worldwide

CNSBio is developing CNSB001 (CNSB 001), a combination

therapy based on the co-administration of the potassium

channel opener flupirtine with an opioid drug, for the

treatment of neuropathic pain. A phase IIa trial of the

technology in the treatment of neuropathic pain in

HIV-infected patients is ongoing. A phase I/IIa trial in

cancer patients with neuropathic pain has completed; phase

IIb evaluation in Europe is planned for commencement in

late 2009. CNSB001 is available for partnering, worldwide.


available, contact:

Ian Cooke

Managing Director

CNSBio Pty Ltd

Suite 1

651 Victoria Street

Abbotsford

Victoria 3067

Australia

Tel: +61 3 8663 7300

Fax: +61 3 9421 0044


CNSB004


CNSBio is developing CNSB004 (CNSB 004), an injectable

peptide modulator of N-type voltage sensitive calcium

channels, for the potential treatment of severe pain.

Preclinical studies are ongoing in Australia; phase I/IIa

evaluation is expected to start in late 2009. CNSB004 is

available for partnering, worldwide.


available, contact:

Ian Cooke

Managing Director

CNSBio Pty Ltd

Suite 1

651 Victoria Street

Abbotsford

Victoria 3067

Australia

Tel: +61 3 8663 7300

Fax: +61 3 9421 0044


CNSB006


CNSBio is developing CNSB006 (CNSB 006), an oral fixed-dose

combination therapy consisting of a neurokinin 1 antagonist

and an ion channel modulator, for the potential treatment of

inflammatory pain. A phase IIa trial of the agent in pain in

osteoarthritis patients is planned. This program is available

for partnering, worldwide.


available, contact:

Ian Cooke

Managing Director

CNSBio Pty Ltd

Suite 1

651 Victoria Street

Abbotsford

Victoria 3067

Australia

Tel: +61 3 8663 7300

Fax: +61 3 9421 0044





©2006 IMS Health Incorporated or its affiliates. All Rights Reserved.

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News from Shire's 2008 Results

lanthanum carbonate

Shire registered, Japan (hyperphosphatemia)

Shire reported in a presentation of its results for the year to

31 December 2008, on 19 February 2009, that lanthanum

carbonate (FOSRENOL) was approved in Japan in October

2008. Lanthanum carbonate, a phosphate binding agent for

the treatment of hyperphosphatemia in patients with chronic

kidney failure, was launched in the USA in January 2005 and

has subsequently been marketed for this indication in several

countries worldwide.

Lanthanum carbonate will be marketed in Japan by Bayer

Yakuhin, Bayer’s subsidiary. A Japanese launch is anticipated

first half 2009.

HGT 2610

Shire provides development update

Shire reported in a presentation of its results for the year to

31 December 2008, on 19 February 2009, that it is developing

HGT 2610 as an enzyme replacement therapy for Krabbe

disease (globoid cell leukodystrophy), a lysosomal storage

disorder. Early-stage preclinical development is under way in

Europe.

SPD 503

Shire resubmits NDA to US FDA

In a presentation of its results for the year to 31 December

2008, on 19 February 2009, Shire announced that on 27

January 2009 it resubmitted an NDA to the US FDA for SPD

503 (INTUNIV) for the treatment of attention deficit

hyperactivity disorder (ADHD) in children. In June 2007, the

FDA issued an approvable letter in response to Shire’s August

2006 filing for SPD 503 for ADHD in children and adolescents.

SPD 503, an oral once-daily extended-release formulation of

guanfacine hydrochloride, is a noradrenergic alpha-2 agonist

with specific affinity for the A subtype prevalent in the

cerebral cortex.

icatibant

Shire provides development update

In a presentation of its results for the year to 31 December

2008, on 19 February 2009, Shire reported on a December

2008 meeting between the US FDA and Shire’s subsidiary,

Jerini. In the meeting, to discuss the FDA’s not approvable

letter for icatibant (FIRAZYR), it was agreed that an

additional clinical study would be required. A complete

response to the not approvable letter will be filed following

this trial, which is expected to initiate third quarter 2009.

Icatibant, a bradykinin-2 receptor antagonist, was launched

in September 2008 in the UK and Germany for the treatment

of acute attacks of hereditary angioedema (HAE).

Products & Biotechnology

resatorvid

Takeda discontinued

Takeda reported on 20 February 2009 that it has discontinued

further development of resatorvid (TAK 242). The decision

was taken because the program did not meet Takeda’s criteria

to support continued development; not because of concerns

over safety or efficacy of the agent. Resatorvid, an inhibitor

of inflammatory mediator production, had been under phase

III evaluation in the treatment of severe sepsis.

NS 2359

GlaxoSmithKline discontinued, Worldwide

(depression)

GlaxoSmithKline clinical data (phase II) (depression)

On 23 February 2009 NeuroSearch reported that data from a

phase II proof-of-concept program of NS 2359, conducted by

GlaxoSmithKline in patients with major depressive disorder,

do not support further development of the agent for the

treatment of depression. Results from two ten-week

randomized, double-blind, active- and placebo-controlled

trials in approximately 900 patients demonstrated no

significant difference in efficacy between NS 2359 and

placebo on key efficacy endpoints of the Montgomery-Asberg

Depression Rating Scale (MADRS), Bech 6-item Scale




(subscale of the HAM-D-17) and IDS-CR (Inventory of

Depressive Symptomatology - Clinicians Rated). However,

treatment with active controls (paroxetine or venlafaxine)

showed statistically significant efficacy compared with

placebo. GlaxoSmithKline is conducting further analysis and

evaluation of the phase II data.

NS 2359, a triple 5HT, noradrenaline and dopamine reuptake

inhibitor, is also undergoing phase II evaluation in the USA

for the potential treatment of attention deficit hyperactivity

disorder (ADHD) and drug addiction.

albiglutide

GlaxoSmithKline phase change III, USA (diabetes)

GlaxoSmithKline announced on 17 February 2009 that it has

begun dosing in a phase III program of albiglutide (SYNCRIA)

in patients with type II diabetes. The program, involving over

4000 patients enrolled in five studies, will aim to evaluate

the efficacy and cardiovascular safety of the agent,

administered as monotherapy or as an adjuvant at a dose of

30 mg weekly. Most studies will include an active comparator

drug (including metformin, sulfonylurea, thiazolidinedione,

insulin and a dipeptidyl peptidase IV inhibitor). The primary

endpoint for all studies will be the change from baseline in

HbA1c compared with placebo and/or active comparator

drugs. Initiation of this phase III program will result in a

US$9 million milestone payment to Human Genome Sciences,

to be paid during first quarter 2009.

Albiglutide, an injectable glucagon-like peptide-1 (GLP-1)

agonist, is a fusion protein consisting of human albumin and

GLP-1 which was originated by Human Genome Sciences

using its proprietary albumin-fusion technology. Human

Genome Sciences licensed albiglutide to GlaxoSmithKline in

October 2004.

aliskiren + amlodipine +

hydrochlorothiazide

Novartis phase change III, USA, Belgium, Slovak

Republic, Egypt, Germany, Poland, Spain, Turkey

(hypertension)

In its annual report 2008, Novartis announced that it is

developing a single pill combination (SPC) of aliskiren,

amlodipine and hydrochlorothiazide for the treatment of

hypertension. Phase III evaluation of the combination is

ongoing, and regulatory submissions in the EU and the USA

are expected in 2010.

vaccine, Clostridium difficile,

Sanofi Pasteur

Sanofi Pasteur phase change II, UK (bacterial

infection)

On 17 February 2009 Sanofi Pasteur announced the initiation

of a proof-of-concept phase II trial of its Clostridium difficile

vaccine (ACAM-Cdiff) in the UK. The study will assess the

safety and efficacy of the vaccine in patients infected with C

difficile. The orally active toxoid vaccine is being developed

for the prevention of C difficile infection. It consists of

native, full length, inactivated toxins A and B, which are

highly immunogenic. This vaccine entered the portfolio of

Sanofi Pasteur via the acquisition of Acambis in September

2008.

nicotinic acid receptor agonist,

Merck & Co/Arena

Merck & Co phase change II, USA (atherosclerosis)

On 18 February 2009 Arena announced that its development

partner, Merck & Co, has initiated a phase II trial of an oral

nicotinic acid (niacin) receptor agonist for the potential

treatment of atherosclerosis. The randomized, double-blind,

placebo-controlled study will evaluate the safety, tolerability

and efficacy of the agent in patients with dyslipidemia.

Arena and Merck & Co entered into their research and

licensing agreement for the development of cardiovascular

therapeutics in October 2002.

AV 951

AVEO phase change II, USA, Europe (breast cancer)

On 19 February 2009 AVEO reported that it has initiated an

open-label phase Ib/IIa trial of AV 951 in the USA and Europe

in patients with advanced breast cancer. The phase Ib section

of the trial will evaluate combined daily escalating,

sequential oral doses of AV 951 with standard weekly

administration of iv paclitaxel in approximately 20 patients

with progressive disease. Primary outcome measures include

safety, tolerability and maximum tolerated dose (MTD).




Following determination of the MTD, the phase IIa portion of

the study will evaluate the clinical efficacy of a combined AV

951 and paclitaxel regimen in approximately 25 to 50

patients with metastatic breast cancer and no prior exposure

to chemotherapy.

AV 951, a quinoline-urea derivative and specific inhibitor of

VEGF receptors 1, 2 and 3, is also undergoing phase II

evaluation in patients with metastatic renal cell carcinoma.

EC 145

Endocyte phase change II, USA, Europe, Canada

(ovarian cancer)

Endocyte announced on 19 February 2009 that it has

initiated a randomized phase II trial of EC 145 in patients

with p lat inum-res istant ovar ian cancer . This

US/Canadian/European trial (designated PRECEDENT),

involving 122 patients, will aim to evaluate the safety and

efficacy of EC 145 given in combination with pegylated

liposomal doxorubicin compared with pegylated liposomal

doxorubicin monotherapy. Endocyte’s molecular imaging

agent, EC 20, will be used to identify patients who will

benefit from EC 145 therapy.

EC 145 is a folate-targeted drug conjugate comprising folic

acid and the vinca alkaloid, desacetylvinblastine hydrazide

(DAVLBH).

vaccine, gene-based, HIV infection,

GeoVax

GeoVax phase change II, USA, Peru (HIV infection)

On 20 February 2009 GeoVax announced that the first

patients in a phase IIa trial, designated HVTN 205, have

received its candidate HIV/AIDS vaccine. The trial, which is

being conducted by the HIV Vaccine Trials Network (HVTN),

will enroll 225 volunteers across 11 sites in the USA and two

sites in Peru. Of the 225 volunteers, 150 will receive GeoVax’s

vaccine and 75 will receive placebo.

GeoVax’s anti-HIV vaccine employs a prime-boost approach,

with a DNA priming dose, followed by the delivery of a

recombinant modified vaccinia Ankara (rMVA) booster. The

vaccine is designed to stimulate anti-HIV T-cell and anti-HIV

antibody immune responses.

TB 402

BioInvent, ThromboGenics phase change II, Europe

(thrombosis)

On 23 February 2009 ThromboGenics and BioInvent

announced that the first patient has been enrolled in a phase

II trial of TB 402 in Central Europe. A single intravenous bolus

injection of the agent will be assessed in the treatment of

deep vein thrombosis after knee surgery in approximately 300

patients. The safety and efficacy of three escalating doses of

TB 402 will be the primary endpoint of the study. The study is

expected to complete by end of 2010. TB 402, a recombinant

long-acting human monoclonal antibody directed against

factor VIII, has potential in the prevention and treatment of

thrombosis, and the prevention of blood clots associated

with atrial fibrillation.

SGN 35

Seattle Genetics phase change II, USA, Canada,

Europe (Hodgkin's lymphoma)

On 19 February 2009 Seattle Genetics reported that it has

initiated a pivotal phase II trial of SGN 35 in patients with

relapsed or refractory Hodgkin’s lymphoma, under a Special

Protocol Assessment (SPA) with the US FDA. The single-arm

multicenter study in the USA, Canada and Europe, will

evaluate the safety and efficacy of SGN 35 (1.8 mg/kg every

three weeks) in approximately 100 patients who have

previously received autologous stem cell transplantation.

The primary endpoint of the trial will be objective response

rate; secondary endpoints include duration of response,

progression-free survival, overall survival and tolerability.

SGN 35, an anti-CD30 antibody conjugated with eight

molecules of the cytotoxic drug monomethyl auristatin E

(MMAE), is being developed for the potential treatment of

hematological cancers. A phase I dose-escalation trial of SGN

35 is ongoing in the USA; data are expected to be reported

during 2009. Seattle Genetics also plans to initiate a phase II

trial in approximately 55 patients with relapsed or refractory

systemic anaplastic large cell lymphoma (ALCL) in the first

quarter of 2009. An NDA filing for the agent under the

accelerated approval regulations is planned for 2011.




NKTR 105

Nektar phase change I, USA (solid tumor)

Nektar reported on 17 February 2009 that it has begun a US

phase I trial to assess the safety, pharmacokinetics and

antitumor activity of NKTR 105 in approximately 30 patients

with refractory solid tumors who have failed all prior

treatments. The agent is a pegylated form of docetaxel that

utilizes Nektar’s advanced polymer conjugate technology.

DM 1992

DepoMed phase change I, Russia (Parkinson's

disease)

On 17 February 2009 DepoMed announced that it has

initiated a randomized, open-label, crossover phase I trial in

Russia to compare the pharmacokinetics of two distinct

formulations of DM 1992 and a generic version of Sinumet CR

sustained-release levodopa/carbidopa, in approximately 18

patients with stable Parkinson’s disease. DM 1992 is a gastric

retentive extended-release formulation of levodopa and

carbidopa, which is being developed using DepoMed’s

AcuForm delivery technology. In July 2008, DepoMed was

awarded a grant by the Michael J. Fox Foundation for the

development of DM 1992.

ABT 450

Abbott, Enanta phase change I, USA

Abbott and Enanta announced on 18 February 2009 that they

have initiated a phase I trial of ABT 450. The double-blind,

placebo-controlled study will evaluate the safety,

tolerability, and pharmacokinetics of single, ascending oral

doses of ABT 450 in healthy volunteers.

ABT 450, a hepatitis C virus (HCV) NS3 and NS3/4A protease

inhibitor, was discovered by Abbott and Enanta as part of

their collaboration agreement to develop agents to treat HCV

infection. In preclinical studies, ABT 450 demonstrated

favorable potency across various HCV genotypes and highly

resistant strains in vitro.

LX 214

Lux Biosciences phase change I, USA (eye disease)

Lux Biosciences reported on 17 February 2009 that it has

initiated a phase I trial of LX 214. The study will evaluate the

safety and tolerability of the agent when applied topically to

the eye of patients with keratoconjunctivitis sicca (dry eye

syndrome) and healthy volunteers.

LX 214, a mixed micellar formulation of the calcineurin

inhibitor voclosporin, is being developed for the potential

treatment of dry eye syndrome and other inflammatory eye

diseases.

CB 182804

Cubist phase change I, USA

Cubist reported on 17 February 2009 that it has initiated a US

phase I trial to evaluate the safety and pharmacokinetics of

CB 182804 in healthy volunteers. CB 182804 is a broad

spectrum lipopeptide antibiotic being developed for the

intravenous treatment of multi-drug resistant Gram negative

bacterial infections. Following the results of this study,

Cubist plans to conduct phase II trials to assess the safety

and efficacy of the agent in patients with Gram negative

infections.

MVA-BN-HER2

Bavarian Nordic clinical data (breast cancer)

Pharmexa sells patent rights to Bavarian Nordic

On 23 February 2009 Bavarian Nordic reported updated

results from phase I/II trials of MVA-BN-HER2 in breast

cancer patients. The primary endpoint (safety) was met, and

approximately 70% of evaluated patients had an

MVA-BN-HER2-induced anti-HER2 immune response. To date,

no disease progression has occurred in 15 out of 30 patients

(after a six-month period). One complete response and one

partial response was observed when the vaccine was

administered with chemotherapy. MVA-BN-HER2 was well

tolerated and no vaccine-related serious adverse events were

reported. A moderate overall immune response was observed.

An improved version of the vaccine had a significantly higher

T-cell immune response in preclinical studies compared with

the original vaccine. The improved vaccine was also effective




in other tumor models in HER2 transgenic mice.

Consequently, Bavarian Nordic has decided to advance the

improved MVA-BN-HER2 vaccine into clinical development; a

single-site US phase I/II trial of this vaccine is expected to

begin during 2009. This study, involving 24 patients, will test

the vaccine in metastatic breast cancer patients and as an

adjuvant in breast cancer therapy.

On 23 February 2009, Pharmexa announced that it has sold

patent rights to MVA-BN-HER2 to Bavarian Nordic. In return,

Pharmexa will receive a single cash payment. MVA-BN-HER2

is a vaccine for the treatment of breast cancer, comprising

Pharmexa’s HER-2 DNA AutoVac vaccine formulated with

Bavarian Nordic’s MVA-BN vector technology.

GTx 758

GTx phase change I, USA

On 23 February 2009 GTx announced the initiation of a

double-blind, placebo-controlled phase I trial of GTx 758 in

healthy men. The study will evaluate the safety, tolerability

and pharmacokinetics of a single ascending dose of the

agent. GTx 758 is an orally-available luteinizing hormone

inhibitor, being developed for the potential treatment of

advanced prostate cancer. In preclinical studies, the agent

rapidly suppressed secretion of luteinizing hormone and then

reduced the production of androgens by the testes in vivo.

GTx plans to initiate a proof-of-concept phase I trial of GTx

758 in 2009.

nabiximols

GW Pharmaceuticals clinical data (muscle spasm)

On 24 February 2009 GW Pharmaceuticals reported results

from a randomized, placebo-controlled, withdrawal study of

nabiximols (SATIVEX) in 36 patients with spasticity

associated with multiple sclerosis. The primary endpoint

(time to treatment failure) was statistically significantly in

favor of nabiximols (p=0.013). In the patient global

impression of change and the carer functional ability global

impression of change, the difference between nabiximols and

placebo was significant (p=0.017 and p=0.001, respectively).

Patients who discontinued nabiximols therapy did not have

withdrawal syndromes, and the severity and frequency of

adverse events were similar for both nabiximols- and

placebo-treated patients. GW Pharmaceuticals expects to

report results from a phase III trial of nabiximols in patients

with spasticity associated with multiple sclerosis end first

quarter 2009. A European regulatory submission for this

indication is expected during second quarter 2009.

The product is marketed in Canada for the treatment of

neuropathic pain in patients with multiple sclerosis and as an

adjunctive analgesic treatment in adult patients with

advanced cancer who experience mild-to-moderate pain.

Nabiximols, a product based on extracts of the plant Cannabis

sativa containing tetrahydrocannabinol and cannabidiol, is

administered as an oral spray.

VGX 3400

VGX preclinical data

VGX reported on 18 February 2009 preclinical data for VGX

3400, an avian influenza DNA vaccine, delivered by

intramuscular or intradermal electroporation (using the

CELLECTRA device). The studies, conducted in macaques in

collaboration with the University of Pennsylvania (USA),

showed that after two vaccinations with VGX 3400, all

macaques in both the intramuscular and intradermal groups

developed hemagglutination inhibition (HAI) titers of

greater than 1:40 against a clade 1 H5N1 virus (sufficient for

protection). The vaccine also elicited HAI titers of greater

than 1:40 against unmatched clade 2 viruses (sub-types 2.1;

2.2; 2.3.4). The vaccine induced significant humoral immune

responses, as well as cellular immune responses to each

component antigen. After post-vaccination challenge with

the A/Vietnam/1203/04 strain, animals achieved significant

reductions in average viral load and disease symptoms

compared with non-vaccinated animals.

VGX 3400 combines three SynCon-based consensus vaccine

constructs targeting HA, NA, and M2e-NP antigens of

H5-influenza; the constructs are not matched to a specific

strain in either of the two main avian influenza families

(clade 1 and clade 2).

mifepristone

Corcept clinical data

Corcept reported on 23 February 2009 data for the main

secondary endpoints of a four-week randomized,

double-blind, controlled clinical trial to evaluate the ability

of mifepristone (CORLUX) to reduce body weight gain and




other metabolic effects related to risperidone (RISPERDAL)

therapy. In the trial, 75 healthy men with a body mass index

of 23 or less, were given risperidone plus placebo (n=30),

risperidone plus mifepristone (n=30) or mifepristone plus

placebo (n=15). Secondary endpoint results showed that

increases in waist circumference (a measure of abdominal

fat) were 2.03 cm and 3.57 cm in the risperidone plus

mifepristone and risperidone plus placebo groups,

respectively (p less than 0.05). Increases in fasting insulin

levels were 1.80 mU/L and 10.97 mU/L (p less than 0.05) and

increases in triglyceride levels were 3.13 mg/dL and 30.57

mg/dL (p less than 0.01) in the respective groups. Previously

announced primary endpoint data indicated mean increases

in body weight which were 5.1 lbs and 9.2 lbs in the

risperidone plus mifepristone and risperidone plus placebo

groups, respectively (p less than 0.0001).

Mifepristone, a GR-II receptor antagonist, is under phase III

evaluation as a therapy for psychotic depression and

Cushing’s syndrome.

PENNVAX-B & PENNVAX-GP

VGX preclinical data

VGX reported on 18 February 2009 data from preclinical

studies, conducted in collaboration with the University of

Pennsylvania (USA), to assess PENNVAX HIV DNA vaccines in

a simian immunodeficiency virus (SIV) challenge non-human

primate model. The magnitude, frequency, proliferative

capacity and polyfunctionality of elicited immune responses

were significantly enhanced when PENNVAX DNA vaccines

were delivered using the CELLECTRA electroporation device

compared with delivery using a recombinant adenovirus

serotype 5 (Ad5) vector.

VGX is developing the PENNVAX HIV DNA vaccines PENNVAX-B

(targets Clade B) and PENNVAX-GP (targets Clades A, C and

D). The HIV Vaccine Trials Network (HVTN) is evaluating

PENNVAX-B as a prophylaxis for HIV infection; a phase I trial

of the vaccine (not using electroporation) in healthy

volunteers is under way. Researchers at the University of

Pennsylvania and Drexel University (USA) are conducting a

phase I trial of PENNVAX-B (not using electroporation) in the

treatment of HIV infection. Follow-up phase I trials of

PENNVAX-B using the CELLECTRA electroporation device are

planned. Preclinical studies of PENNVAX-GP, delivered using

CELLECTRA, are under way.

ondansetron

Stanford University clinical data (phase I) (drug

addiction)

Stanford University School of Medicine (USA) reported on 18

February 2009 data from its program to develop ondansetron

(ZOFRAN), a 5HT3 receptor antagonist, for the treatment of

opioid addiction. In a clinical trial in eight, healthy,

non-opioid-dependent subjects, a single, large dose of

morphine was given in one session. In another session (at

least one week later) ondansetron was given in combination

with morphine. Withdrawal symptoms were assessed using

questionnaires. Results indicated a significant reduction in

withdrawal signs when ondansetron was given before or

concurrently with morphine, compared with morphine

administration without ondansetron therapy. These data

reflect those of studies in mice in which ondansetron

demonstrated efficacy in treating morphine addiction

(reduction in jumping behavior and pain sensitivity).

Ondansetron is widely marketed by GlaxoSmithKline for the

prevention of chemotherapy-induced nausea and vomiting

and for post-operative nausea and vomiting.

AN 2728

Anacor clinical data (phase II) (psoriasis)

On 19 February 2009 Anacor reported results from a second

phase II trial of AN 2728, an oxaborole being developed for

the topical treatment of psoriasis. The randomized,

double-blind, placebo-controlled study involved 30 patients

who treated one of their psoriasis plaques with AN 2728 5%

ointment twice-daily; a matching psoriasis plaque on the

other side of the body was treated with vehicle ointment

alone. The trial met its objective of defining optimal duration

of treatment. AN 2728-treated plaques had a lower overall

target plaque severity score (OTPSS) in a significantly greater

proportion of patients compared with vehicle-treated

plaques; improvement was observed within two weeks of

therapy (p less than 0.001) and optimal responses were noted

at six to eight weeks (p less than 0.01). Individual signs of

psoriasis and OTPSS were significantly reduced. Complete

clearance of plaque was seen in 13% of treated plaques while

43% of plaques were clear or almost clear with a two-grade

improvement from baseline. AN 2728 ointment was well

tolerated and application site irritation was the most




common side effect. Anacor plans to begin a dose-ranging

phase IIb trial of AN 2728 during second half 2009.

AN 2728 is a boron-containing small molecule that inhibits

the phosphodiesterase IV enzyme, suppressing the release of

pro-inflammatory cytokines including TNF-alpha, IL-12 and

IL-23.

vaccine, NSCLC, Transgene

Transgene clinical data (phase II) (NSCLC)

Transgene reported on 17 February 2009 21-month median

follow-up data from a European phase IIb trial of its TG 4010

(MVA-MUC1-IL2) immunotherapy in 148 patients with

advanced nonsmall cell lung cancer (NSCLC). Half of the

patients received TG 4010 in combination with cisplatin and

gemcitabine; the remainder received chemotherapy alone.

Results confirmed a statistically significant greater median

survival in the TG 4010/cisplatin/gemcitabine group (17.1

months) compared with the chemotherapy alone group (11.3

months) in patients with normal activated natural killer cell

levels at baseline (approximately 75% of enrolled patients).

This patient sub-population was identified by Transgene’s

biomarker program, data from which provided evidence that

TG 4010 has a Th1-dependent pathway of activity in cancer

patients. The trial met its statistical primary endpoint of at

least a 40% six-month progression-free survival (PFS);

six-month PFS rate was 44% and 35% in the TG

4010/cisplatin/gemcitabine and chemotherapy alone

groups, respectively. Transgene expects to meet with the US

FDA and the EMEA second quarter 2009 regarding plans for a

phase III program in metastatic NSCLC.

TG 4010 comprises a recombinant vaccinia virus (based on

the Modified Virus Ankara (MVA)) that incorporates genes

encoding the MUC-1 tumor-associated antigen and

interleukin-2 (IL-2).

Genz 112638

Genzyme clinical data (phase II) (Gaucher's

disease)

Genzyme reported on 20 February 2009 further data from an

international phase II trial to assess the efficacy, safety and

pharmacokinetics of Genz 112638 (a glucosylceramide

analogue) oral capsules in the treatment of type I Gaucher’s

disease. The composite primary efficacy endpoint of a

clinically meaningful response in at least two of three

endpoints (improvements in spleen size, hemoglobin and

platelet levels) after 52 weeks of the trial period, was met.

Twenty-two (of 26 enrolled) patients completed at least 52

weeks of Genz 112638 therapy. At 12 months there were

mean decreases from baseline of 39% and 17% in spleen and

liver volumes, respectively. Mean increases in blood

hemoglobin levels and platelet counts were 1.62 g/dL and

40% from baseline, respectively. In the 20 patients treated

with chitotriosidase, levels of this enzyme were reduced by a

median of 51% from baseline. These data were comparable to

those observed following one year of imiglucerase

(CEREZYME) treatment. Genz 112638 demonstrated good

tolerability and a favorable safety profile. Of the adverse

events, 91% were unrelated to Genz 112638 therapy.

Drug-related adverse events were mild and transient; they

were experienced by a small number of patients early in

treatment and did not need medical intervention. Related

adverse events in the trial included infrequent abdominal

discomfort and diarrhea, and transient palpitations and

headache. A potential link between asymptomatic

non-sustained ventricular tachycardia and sub-quantifiable

levels of Genz 112638 was thought unlikely by investigators.

After the trial had completed, all 20 eligible patients

remained on Genz 112638 therapy; over 50% of patients have

completed more than two years of treatment. Patient

treatment is ongoing; longer-term efficacy data are being

collected. A phase III trial in untreated patients with type I

Gaucher’s disease and a phase III maintenance trial in which

patients who have achieved their therapeutic goals with

imiglucerase, are expected to start mid 2009.

NPL 2008

Neuropharm clinical data (phase III) (autism)

On 18 February 2009 Neuropharm reported preliminary

results from a US phase III trial (designated SOFIA) of NPL

2008 in 158 patients (aged five to 17 years) with autistic

disorder. Data showed that the CYBOCS-PDD measure of

repetitive behaviors was reduced after 14 weeks of treatment

with either NPL 2008 or placebo. However, the study did not

achieve its primary endpoint of a statistically significant

difference between the two groups. NPL 2008 was generally

well tolerated, and no serious adverse events were observed.

Full analysis of the primary and secondary data from the trial

is ongoing.




NPL 2008, a formulation of the selective serotonin reuptake

inhibitor fluoxetine delivered through Catalent’s ZYDIS

tablet, is being developed for the potential treatment of

children and adolescents with autism. A rolling NDA for NPL

2008 was submitted to the US FDA in September 2008.

rosuvastatin

AstraZeneca clinical data (phase III)

(cardiovascular disease)

AstraZeneca reported on 19 February 2009 further results

from its phase III JUPITER (Justification for the Use of

statins in Primary prevention: an Intervention Trial

Evaluating Rosuvastatin) trial of rosuvastatin (CRESTOR).

Benefits in higher risk patients, including those older than

70, cigarette smokers, hypertensives, those with an elevated

Framingham risk score and those with a hsCRP

(high-sensitivity C-reactive protein level) at or above 5

mg/dL at baseline, were demonstrated. No increase in the

risk of hemorrhagic stroke was observed, and rosuvastatin

was well tolerated. Initial results, reported in November

2008, showed that treatment with 20 mg of the agent

reduced major cardiovascular events (the combined risk of

myocardial infarction, stroke, arterial revascularization,

hospitalization for unstable angina or death from CV causes)

by 44% compared with placebo (p less than 0.001) in subjects

with elevated hsCRP but low to normal cholesterol levels. The

combined risk of heart attack, stroke or CV death was reduced

by 47% (p less than 0.001), the risk of heart attack by 54% (p

less than 0.001), the risk of stroke by 48% (p=0.002), and

total mortality was reduced by 20% (p=0.02).

Rosuvastatin is available in numerous markets worldwide as a

treatment for hyperlipidemia. AstraZeneca expects to file a

regulatory submission including data from the phase III

JUPITER trial during first half 2009.

UDB

MAP Pharmaceuticals clinical data (phase III)

(asthma)

On 23 February 2009 MAP Pharmaceuticals reported results

from its randomized, double-blind, placebo-controlled phase

III trial of unit dose budesonide (UDB). During the trial, 360

asthmatic children were randomized to receive UDB 0.25 mg,

UDB 0.135 mg or placebo bid for 12 weeks. The co-primary

endpoints (asthma control as assessed by changes from

baseline in nightime and daytime composite symptom

scores) were not achieved for either of the tested doses when

compared with placebo. Drug-related serious adverse events

were not identified in an initial data review. A 52-week safety

trial, evaluating the long-term effects of the two doses, is

ongoing. MAP Pharmaceuticals, together with partner

AstraZeneca, will conduct additional analyses of the data to

evaluate how to progress the program.

UDB, a nebulized formulation of budesonide that utilizes

Elan’s NanoCrystal technology, is being developed as a

potential treatment for pediatric asthma.

ALKS 27

Alkermes begins phase IIa trial

On 18 February 2009 Alkermes announced that it has begun a

randomized, double-blind, crossover, placebo-controlled

phase IIa trial of ALKS 27 in approximately 24 patients with

chronic obstructive pulmonary disease (COPD). Patients will

be given single administrations of three doses of ALKS 27 and

placebo, each separated by a washout period. Efficacy will be

measured using FEV1 (improvement in pulmonary function).

Following the randomized, double-blind, placebo-controlled

portion of the study, all patients will receive ALKS 27 in

combination with formoterol inhalation powder to evaluate

the safety, tolerability and effects of the combination.

Top-line results from this study are expected during second

half 2009.

Alkermes’ ALKS 27 (developed with partner Indevus) is an

inhaled formulation of trospium chloride, a muscarinic

receptor antagonist that relaxes smooth muscle tissue, and is

delivered using Alkermes’ proprietary AIR pulmonary delivery

system.

ChimeriVax-Dengue

Sanofi Pasteur initiates phase IIb trial in Thailand

On 18 February 2009 Sanofi Pasteur announced the initiation

of a phase IIb trial of its recombinant dengue vaccine,

ChimeriVax-Dengue, in Thailand. The study will assess the

efficacy of the vaccine in the prevention of dengue fever in

children. The ChimeriVax-Dengue vaccine was developed

using the ChimeriVax technology licensed from St Louis

University (USA) and is directed against all four serotypes of




dengue virus. A phase IIa trial of the vaccine was initiated in

2005 in the USA.

riociguat

Bayer Schering receives UK ethical approval for two

phase III trials

Bayer Schering announced on 18 February 2009 that it has

been granted ethical approval to begin two UK phase III trials

of riociguat in patients with chronic thromboembolic

pulmonary hypertension (CTEPH) and pulmonary arterial

hypertension (PAH). The double-blind, randomized,

placebo-controlled CHEST-1 study will enroll 270 CTEPH

patients. Efficacy will be measured as change from baseline in

patients’ exercise capacity using the six-minute walking

distance test. Following 16 weeks of therapy, patients may

elect to enter into an open-label extension study (CHEST-2)

to evaluate long-term safety and efficacy. The second phase

III trial, PATENT-1, will be a randomized, double-blind,

placebo-controlled study in 460 PAH patients who are either

treatment-naive or are receiving an endothelin receptor

antagonist or prostacyclin analogue. The primary endpoint

will be the same as the CHEST-1 trial, and patients may elect

to enter into an open-label extension study (PATENT-2) at

the end of the PATENT-1 study. Initial results from both

studies are expected in 2011.

Riociguat is an oral stimulator of soluble guanylate cyclase.

MAb, VAP-1, BioTie Therapies

BioTie Therapies initiates rheumatoid arthritis trial

On 17 February 2009 BioTie Therapies announced the

initiation of a phase I trial of BTT 1023, its fully human

monoclonal antibody against VAP-1, in patients with

rheumatoid arthritis. The trial, which will be conducted in the

EU, will evaluate the safety and tolerability of the antibody in

up to 36 patients. Results are expected first half 2010. A

phase I trial in psoriasis patients is expected to initiate

during first quarter 2009.

Roche paid BioTie Therapies an option initiation fee of EUR5

million for an exclusive option right to an exclusive,

worldwide license agreement for the VAP-1 monoclonal

antibody, excluding Japan, Taiwan, Singapore, New Zealand

and Australia. This option will end upon the completion of

phase I, but may be extended by Roche to later development

points upon payment of additional fees.

Q 8003IR

QRxPharma initiates comparative US trial

QRxPharma announced on 19 February 2009 the initiation of

a clinical trial comparing the analgesic efficacy of Q 8003IR

(MoxDuoIR) with oxycodone plus acetaminophen (PERCOCET)

and iv morphine (patient controlled analgesia) in patients

with moderate-to-severe pain following total knee

replacement surgery. The trial is expected to enroll 45

patients at three sites in the USA. Patients will receive

treatment every 4 to 6 h for 48 h. Results from the trial will be

used to establish the optimal dose regimen for Q 8003IR, to

select an appropriate control group and in the design of a

pivotal phase III trial.

Q 8003IR is an immediate-release oral formulation of

morphine and oxycodone. A phase III trial of the product in

patients with moderate-to-severe pain after bunionectomy

was initiated in the USA in November 2007.

IPI 940

Infinity selects clinical development candidate

On 9 February 2009 Infinity reported that it has selected IPI

940, a fatty acid amide hydrolase (FAAH) inhibitor, as a

clinical development candidate for the potential treatment

of neuropathic pain.

vaccine, cat allergy, Alk-Abello

Alk-Abello evaluating cat allergen

Alk-Abello is developing an oral tablet formulation of a

recombinant cat allergen, as a vaccine against cat allergy.

Alk-Abello announced on 23 February 2009 that it has signed

an agreement with Novozymes under which the latter will

provide know-how and develop a microbial production

process to manufacture the allergen. Alk-Abello is

responsible for preclinical and clinical evaluation, and

commercialization of the vaccine.




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Company Focus

Focus on Gene Signal

International

Founded in 2000, Gene Signal International (Lausanne,

Switzerland) is a biotechnology company specialized in the

discovery, development, and commercialization of

oligonucleotides, proteins and monoclonal antibodies for the

treatment of a range of conditions where angiogenesis plays

a determinant role. The company uses a patented gene

discovery platform GENE-MAAP (GENE Signal Multiple

Angiogeneis, Angiostatic Platform) which allows the

identification of genes involved in the angiogenic and

angiostatic process. Gene Signal International’s most

advanced compound, GS 101, has entered phase III trials for

the management of neovascularisation associated corneal

graft rejection.

GS 102

Gene Signal International partnering opportunity,

Worldwide

Gene Signal International informed R&D Focus that it is

developing the antisense oligonucleotide GS 102 as a

potential topical therapy for diabetic retinopathy. The agent

was discovered using Gene Signal’s proprietary scientific

platform GENE-MAAP (GENE Signal Multiple Angiogenesis,

Angioplastic Platform). Preclinical studies are ongoing in

Switzerland. The agent is available for partnering worldwide.


available, contact:

Eric Viaud

CEO

Gene Signal International SA

Parc Scientifique EPFL

A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65


GS 101


Worldwide

On 20 February 2009 Gene Signal International informed R&D

Focus that GS 101 is available for partnering in the USA and

Japan for Orphan indications, and worldwide for non-Orphan

indications. GS 101, a topical antisense oligonucleotide

targeting the gene IRS-1, is being developed for the

treatment of various issues related to neovascularisation. GS

101, which was discovered using Gene Signal International’s

proprietary scientific platform GENE-MAAP (GENE Signal

Multiple Angiogenesis, Angioplastic Platform), reduces

corneal neovascularisation. The agent acts via inhibition of

IRS-1 and the modulation of selective transcriptional

activities related to VEGF and IL-1beta expression, while

avoiding complete VEGF suppression. In November 2008 Gene

Signal International initiated a phase III trial of GS 101 in

Germany, Switzerland and France for the prevention of

corneal graft reject ion assoc iated with corneal

neovascularisation. Phase I trials of GS 101 have been

conducted for the treatment of neovascular glaucoma,

retinopathy of prematur ity, age-related macular

degeneration (AMD) as well as in dermatology, for the

treatment of psoriasis and rosacea. The European

Commission has granted GS 101 Orphan designation for the

treatment of neovascular glaucoma, retinopathy of

prematurity and for the prevention of corneal graft rejection.

Gene Signal International plans to initiate phase II trials of

GS 101 in other ophthalmology indications (inhibition of

neovascularization in retina), such as diabetic retinopathy,

in second quarter 2009 in Switzerland, Germany, France and

Spain; a phase II trial of GS 101 for the treatment of psoriasis

and rosacea is planned for second quarter 2009 in Germany

and India.


available, contact:

Eric Viaud

CEO



A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65





GS 156


Worldwide

Gene Signal International is developing the peptide GS 156

for potential use as a wound healing agent. Preclinical

studies are ongoing in Switzerland. GS 156 is available for

partnering worldwide.


available, contact:

Eric Viaud

CEO



A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65


GS 168


Worldwide

Gene Signal International is conducting proof-of-concept

preclinical investigations of the protein GS 168 for the

potential treatment of renal cancer. GS 168 is available for

partnering worldwide.


available, contact:

Eric Viaud

CEO



A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65


GS 497c


Worldwide

Gene Signal International is developing the protein GS 497c

for the potential treatment of lung cancer. Proof-of-concept

preclinical studies are ongoing in Switzerland. GS 497c is

available for partnering worldwide.


available, contact:

Eric Viaud

CEO



A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65


GS 326


Worldwide

Proof-of-concept preclinical studies of GS 326 have been

initiated. The agent is being developed by Gene Signal

International for the potential treatment of pancreatic

cancer. The agent is available for partnering worldwide.


available, contact:

Eric Viaud

CEO



A 1015 Lausanne

Switzerland

Tel: +41 21 804 61 64

Fax: +41 21 804 61 65





NEWLY REPORTED DRUGS IN R&D FOCUS

Company Product Therapeutic Class Indication Phase

Alk-Abello vaccine, cat allergy, Alk-Abello J7C; V1A allergy Discovery

DepoMeddrug delivery system, levodopa + carbidopa,

DepoMedV7A; N4A Parkinson disease Phase I

Gene Signal

InternationalGS 102 S1X diabetic retinopathy Preclinical

Gene Signal

InternationalGS 101 S1P; D5A; S1E; S1X psoriasis; AMD; glaucoma; retinopathy Phase III

Gene Signal

InternationalGS 156 D3A9 wound Preclinical

Gene Signal

InternationalGS 168 L1X9 renal cancer Preclinical

Gene Signal

InternationalGS 326 L1X9 pancreatic cancer Preclinical

Gene Signal

InternationalGS 497c L1X9 lung cancer Preclinical

German Cancer

Research Center

fusion polypeptides, German Cancer Research

CenterL1X9 cancer Discovery

German Cancer

Research Center

NS1 protein/VP1 capsid protein, German Cancer

Research CenterL1X9 glioblastoma Preclinical

GTx GTx 758 L2B9 prostate cancer Phase I

HUYAdrug discovery, HUYA/Beijing Institute of Materia

MedicaV3X all other therapeutics Discovery

Lilly ion channel modulators, NeuroSearch/Lilly N7X neurological Discovery

Nostrum caerulomycin A L4A transplant rejection; inflammation Preclinical

Novartis aliskiren + amlodipine + hydrochlorothiazide C8A; C3A3; C9X hypertension Phase III

Shire HGT 2610 V3X enzyme deficiency Preclinical

See IMS LifeCycle, R

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NEWLY REPORTED DRUGS IN R&D FOCUS

Company Product Therapeutic Class Indication Phase

Stockbridge

Pharmaceuticalscancer therapy, Stockbridge Pharmaceuticals L1X9 cancer Preclinical

VGX vaccine, gene-based, HIV Clade B, VGX J7A9 HIV infection Phase I

VGX vaccine, gene-based, HIV Clades A, C and D, VGX J7A9 HIV infection Preclinical

26


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PRODUCT PHASE CHANGES REPORTED IN R&D FOCUS

Company Product Therapeutic Class* Indication New PhaseRegion of Phase

ChangeHighest Phase

AVEO AV 951 L1X4 breast cancer Phase II USA; Europe Phase II

Bialeslicarbazepine

acetateN3A epilepsy Recommended EU Pre-registration

Cubist CB 182804 J1X9 bacterial infection Phase I USA Phase I

DepoMed DM 1992 V7A; N4A Parkinson disease Phase I Russia Phase I

Enanta ABT 450 J5B1 hepatitis C Phase I USA Phase I

Endocyte EC 145 L1X9 ovarian cancer Phase IIUSA; Europe;

CanadaPhase II

Ferring degarelix L2B9 prostate cancer Registered EU Registered

Fresenius catumaxomab L1X3 cancer Recommended EU Pre-registration

GeoVaxvaccine, gene-based,

HIV infection, GeoVaxJ5C9 HIV infection Phase II USA; Peru Phase II

GlaxoSmithKline albiglutide A10S diabetes Phase III USA Phase III

GTx GTx 758 L2B9 prostate cancer Phase I USA Phase I

Lilly prasugrel B1C2 acute coronary syndrome Registered EU Registered

Lux Biosciences LX 214 S1X; V7A eye disease Phase I USA Phase I

Merck & Co

nicotinic acid

receptor agonist,

Merck & Co/Arena

C10A9 atherosclerosis Phase II USA Phase II

Nektar NKTR 105 L1C solid tumor Phase I USA Phase I


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PRODUCT PHASE CHANGES REPORTED IN R&D FOCUS

Company Product Therapeutic Class* Indication New PhaseRegion of Phase

ChangeHighest Phase

Novartisaliskiren + amlodipine

+ hydrochlorothiazideC8A; C3A3; C9X hypertension Phase III

USA; Belgium;

Slovak

Republic;

Egypt;

Germany;

Poland; Spain;

Turkey

Phase III

ProStrakan

drug delivery system,

sublingual fentanyl

citrate, Orexo

N2A; V7A pain Marketed UK; Germany Marketed

Sanofi Pasteur

vaccine, Clostridium

difficile, Sanofi

Pasteur

J7A9 bacterial infection Phase II UK Phase II

Seattle Genetics SGN 35 L1X3 Hodgkin lymphoma Phase IIUSA; Canada;

EuropePhase II

Shire lanthanum carbonate V3G hyperphosphatemia Registered Japan Marketed

Takeda KAPIDEX A2B2; V7A GERD Marketed USA Marketed

ThromboGenics TB 402 B1X thrombosis Phase II Europe Phase II

Vion laromustine L1A AML Pre-registration USA Pre-registration

Wyeth bazedoxifene G3J osteoporosis Recommended EU Pre-registration

* A change in phase may not apply to all therapeutic classes and indications

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