AETAPI and Generics

Reaching goals together. In an atmosphere of trust and partnership.

AET | Corporation

AET | API

AET | Laboratories

AET | Worldwide presence

AET | Generics

AET | Partnerships

AET | Business development

AET | Contact

Chapter Page

Index

04

06

10

12

16

20

22

24

-

-

-

-

-

-

-

05

09

11

15

19

21

23

03

Mission

We shall set the benchmark for successful

independent generic medicine development. What we

do, we do right and the passion of our people shall be

our partner’s guarantee. We will at all times provide

solutions that exceed best industry practice whilst

focussing on commercial value. Patients around the

globe will benefit from access to good value medicine

that is developed and manufactured in supply chains

authorized by Health Authorities in the EU. We call

ourselves Tifis (shortened from “Tiefenbacher”) and we

take pride in doing our part to improve the health of

the world.

Vision

Change is our single constant helping us stay

ahead of global market developments. AET will

continue to transform to become the most recognized

brand for medicine development and medicine

provision to marketers throughout the world through

concentration on core competencies and expansion

of know how, service and science in every conceivable

area of generic research and development.

Founded 1963 in Hamburg by the Company’s

namesake Alfred E. Tiefenbacher, AET has

been growing successfully as the world’s first

exclusive API agency in the market for active

pharmaceuticals for 50 years.

Representing active pharmaceutical

ingredient (API) producers has provided

the foundation for AET’s growth into a

pharmaceutical company capable of

independently developing, registering and

supplying finished dosage form (FDF)

generic pharmaceuticals to marketing

organizations internationally. AET enjoys

an industry leading reputation for technical

excellence and service.

AET. Decades of experiencefor enduring relationships.

0504

Acquisition and marketing management

of API has been shaping the core business

for almost five decades. Through years of

effective collaboration with selected API

suppliers, AET has become one of the world’s

leading API agents.

Transparency, a long standing and profound

knowledge of the continuously changing API

market and its significance in healthcare, as well as

anticipation and flexibility when dealing with radical

changes in the industry have allowed AET to grow

continuously over the last 50 years.

Through relationships with leading principals,

suppliers and clients based on successful and trusting

collaboration, AET has the experience and ability

to exceed the needs of the pharmaceutical and API

industries.

AET and active pharmaceutical ingredients. A corporation growing through challenges.

0706

Acquisition and marketing management

of API has been shaping the core business

for almost five decades. Through years of

effective collaboration with selected API

suppliers, AET has become one of the world’s

leading API agents.

Transparency, a long standing and profound

knowledge of the continuously changing API

market and its significance in healthcare, as well as

anticipation and flexibility when dealing with radical

changes in the industry have allowed AET to grow

throughout the last 50 years.

Through relationships with leading principals,

suppliers and clients based on successful and trusting

collaboration, AET has the experience and ability

to exceed the needs of the pharmaceutical and API

industries.

AET and active pharmaceutical ingredients. A corporation growing through challenges.

07

AET_V7_RZ_240712.indd 7 30.08.12 11:21

AET is a pioneer in the international active

pharmaceutical ingredient market. The

trusting relationships that AET enjoys with its

suppliers and commissioners have been the

key to its success. RECORDATI S.p.A., as one

example among many, has been represented

successfully by AET for over 40 years. Today,

AET represents nearly 20 international

API manufacturers, AET’s ‘Principals’, the

word that has become a standard term

in the international API business since

its introduction to this use by Alfred E.

Tiefenbacher, along with so many of AET’s

innovative business practices.

Transparency in the relationship between the

manufacturer, the commissioner and AET is of

paramount importance in delivering value to AET’s

clients, and promotes trusting and open collaborations

that are best able to innovate and be efficient in

dealing with complex and challenging situations.

Nearly 50 years’ experience in procurement

management and superb information networks

have established AET as one of the most successful

API procurement companies globally. More than 50

carefully selected API manufacturers from around the

world provide AET’s clients with API.

AET as active ingredient representative. At the interface of production and innovation.

0908

The founding of AET Laboratories in

Hyderabad, India, in 2003 was a further

milestone on AET’s successful path to an

integrated and prolific working corporation.!

Since August 2006 the company operates

under the name AET Laboratories Pvt. Ltd.

At the Hyderabad site, highly motivated scientists and

technicians develop and document generics through

to validated approval and market launch.

The first EU marketing approval for AET was achieved

in October 2006. The extension of the R&D centre to

3,000 m2 was completed in August 2009. One year

later, in September 2010, the 50th development

project was initiated. FDA and ANVISA inspection

will be initiated in 2012/2013.

Key facts

+ State of the art R&D Lab for galenical & analytical

development.

+ Pilot plant for bio batches and small scale

manufacturing, sponsor of biostudies, and

compilation of dossiers for submission in Europe and

third countries in cooperation with AET, Germany

and Cyprus.

+ GMP Pilot Plant audited and approved in 2006 and

2009 by the German Health Authority

+ Scheduled inspections by ANVISA and the FDA for

2012/2013.

AET Labs. Research and development.Integrated solutions for the generics market.

1110

AET’s global footprint.

AET has a history of excellence in service and

collaboration. Today AET is a fully fledged

pharmaceutical company with a portfolio of over 100

generic products developed in its own laboratories

and with partners that are licensed out to market

leaders globally. AET is active in developing diverse

pharmaceutical technologies and products.

Clients benefit from the true expertise of AET in first

to launch generic and OTC marketing authorisations,

bulk or finished packed product supply from robust

and cost effective supply chains, CTD dossiers for

submission in territories outside the EU/EEA, expert

project management and support (Quality Audit, IP

Case Management & Regulatory Affairs).

AET and Aegis Cyprus. Small-scale

production and expansion of AET’s

service portfolio.

In autumn 2009 AET entered into a strategic

partnership with Aegis in Cyprus. With this step

AET secured a trusted partner for pharmaceutical

manufacturing, packing and analytics in southern

Europe. Additionally Aegis gives regulatory support

for early emerging markets by obtaining Certificates of

Pharmaceutical Products (CPP) in Cyprus.

Our internationally active customers use such CPPs

to register “fast track” in targeted markets of Africa,

South East Asia, Latin America and elsewhere. Further

to this, Aegis now also serves as co-marketing partner

for our clients. Given the existing, registered and

ready-to-distribute brand in developing countries, our

customers can enter into these markets or expand the

existing product portfolio even faster than before.

Key facts

+ Capacity for manufacturing of solid dosage forms

+ Flexible for short-term supply requirements

+ Primary and secondary packaging with short change

over times

+ Extensive and enlarged EU batch control and EU

release capabilities

+ Large, growing product portfolio ready-to-use for

co-marketing purposes in Africa, S-E-Asia and other

developing regions

AET Worldwide.Local expertise supported by global resources.

1312

AET Malta. Early

market entry support.

Using the exceptional situation of the Republic of Malta

in terms of intellectual property, AET Malta materialises

the possibility to act and serve freely for timely

launches for non-protected markets. The perfect

pharmaceutical infrastructure, the logistic benefits

in terms of sea and air travel and the participation of

Malta as member state of the EU more than justified

the incorporation of AET Malta in 2010.

AET China. Representative office in Beijing.

AET has recently established local representation

in Beijing to facilitate collaboration with API

manufacturers, development partners and customers

in the market, and to provide local capabilities in

sourcing, regulatory support and market intelligence.

This builds on AET’s excellent network in one of the

world’s leading developing markets.

AET Brazil. Supporting Brazil’s leading

pharmaceutical companies.

Taking into consideration the promising development

and the high potential of Brazil as a pharmaceutical

market, AET since one year has established being

present with AET staff in Sao Paulo. Our licensing

managers are located in M. Cassab’s offices and with

this cooperation are taken by the helping hand of our

local partner. This way we can provide comprehensive

development, registration and supply services to those

Brazilian companies, we do not serve already from

our head office in Germany. Furthermore we expand

into the most promising countries like Argentina

and Venezuela from Sao Paulo, making use of the

high standards of ANVISA that are widely accepted

throughout Latin America.

AET. USA. Establishing a presence

in a dynamic generics market.

AET has established local representation via Byron

Chemicals Ltd. to serve the local US companies. Our

key accounts however are maintained via our global

partnering approach from Germany. The US as one

of the most established generic markets still gives us

enough room to establish ourselves as high quality

provider of globally set up generic developments.

Establishing a global footprint. Through local support.

1514

AET is an active collaborator in all fields of

pharmaceutical innovation, from generic

drugs through biosimilars to novel product

development. Successful and profitable

collaborations with companies from local

distributors through to big pharma are

supported by a flexible and innovative

approach to licensing and partnering.

The level of both experience and innovation

has led to AET being partner of choice for

many of the world’s leading pharmaceutical

companies.

AET and fi nished dosage forms. Active collaboration for pharmaceutical innovation.

Building on its success as an agent for renowned API

producers, AET expanded into the rapidly developing

market for generics in the 1990s. Today, with its far-

reaching expertise, AET counts among the leading

European corporations in the backwardly integrated

generics development sector.

At AET Labs, and with selected international partners,

AET develops tailor-made products – beginning with

development via documentation and registration

through to production, packaging and just-in-time

delivery.

The commissioners also profit from the knowledge and

experience of AET in sustained marketing of a generic.

Directly after the successful launch of a product,

AET marketing experts examine its future chances

and growth potential in the regional markets. From this

they develop applicable strategies for the entire supply

chain, in order to sustainably secure the life cycle of

the product.

1716

AET shares its extensive expertise with

world leading formulation and API synthesis

companies to co-develop generic drugs for

international markets. AET is involved in all

aspects of the development progress from

chemical, galenical and IP aspects, through

to identifying the key regulatory influences

and targets, to ensure that both partners

obtain the most value from the collaboration.

Partners enjoy expert IP advice on the formulation

and submission routes for a product: AET has

frequently been first to market based on IP strategy in

submission.

AET has in-depth experience in the development

and registration of dossiers in all indication areas and

with complex delivery technologies. We have many

years of experience gaining marketing authorisations

worldwide with a large, multilingual and highly qualified

team.

Key facts

+ Professional project setup

+ Transparent project management

+ Pharmaceutical development expertise

+ Regulatory affairs expertise and support to receive

timely marketing authorisations

+ Intellectual property advice and guidance

+ Technical support and quality

+ Innovative licensing approaches

+ Just-in-time launch management

+ Cost and efficiency driven supply chain

management

AET and co-development partnerships.Development, registration and commercial supply in one.

1918

AET shares its extensive expertise with

world leading formulation and API synthesis

companies to co-develop generic drugs for

international markets. AET is involved in all

aspects of the development progress from

chemical, galenical and IP aspects, through

to identifying the key regulatory influences

and targets, to ensure that partners obtain

the most value from the collaboration.

Partners enjoy expert IP advice on the formulation

and submission routes for a product: AET has

frequently been first to market based on IP strategy in

submission.

AET has in-depth experience in the development

and registration of dossiers in all indication areas and

with complex delivery technologies. We have many

years of experience gaining marketing authorisations

worldwide with a large, multilingual and highly qualified

team.

Key facts

+ Professional project setup

+ Transparent project management

+ Pharmaceutical development expertise

+ Regulatory affairs expertise and support to receive

timely marketing authorisations

+ Intellectual property advice and guidance

+ Technical support and quality

+ Innovative licensing approaches

+ Just-in-time launch management

+ Cost and efficiency driven supply chain

management

AET and co-development partnerships.Development, registration and commercial supply in one.

19

AET_V7_RZ_240712.indd 19 30.08.12 11:21

Innovative licensing and collaboration are

at the centre of the AET business, enabling

companies to build their drug portfolios in

partnership with the leading independent

specialist.

AET works hand in hand with clients to identify client

product opportunities, creating targeted strategies to

ensure long-term growth in local and global markets.

Clients reach agreement with AET on contracts

that support a profitable, secure and flexible

framework for the client, taking into consideration

all requirements.

AET offers a comprehensive service from development

through registration to supply and maintenance,

delivering internationally, allowing clients to focus on

successful own brand marketing.

Reasons to partner with AET:

+ Extensive pipeline – planned submissions for more

than 40 molecules worldwide in 2012

+ Portfolio building for long term growth in global markets

+ Consideration of local markets needs: stability zone IV

studies, inspected supply chains, local BE-studies

+ Full assortment available as registered or about-to-

be-registered product in local markets –

no restriction to indications or forms

+ Provision of branding –registered and approved

brand names packed in locally adapted secondary

packaging for growth markets

+ High value justification in emerging markets due

to extensive documentation, exceeding local

requirements but setting standards hard to

copy for local suppliers

+ Local conditions – highly automated and EU

approved processes provide the basis for being

internationally competitive in basically every

market setup

+ Fast market access with granted and available MAs

in all 27 EU member states

+ More than 1000 MAs to come until 2012 or already

available in 27 EU countries

AET and business development. Comprehensive services for successful market entrance.

2120

AET offers its clients tailored support

throughout the complete life cycle of a

product to secure a punctual launch of a

competitive product at excellent quality. This

enables our customers to keep costs and

risks at a minimum while at the same time

relying on AET’s professional project setup.

Common Technologies

+ Tablets (immediate and

modified release,

chewable, ODT)

+ Capsules (hard, soft gel)

+ Solutions

+ Injectables (lyophilised and solutions)

+ Ophthalmics

+ Oral dissolving films (ODF)

+ Patches

+ Semisolids

+ Inhaled therapies

Areas of special interest

+ Cytotoxic drugs

+ Hormones

+ Herbal drugs

+ OTC drugs

+ Controlled drugs

+ High potent drugs

+ New combination products

+ New delivery systems

+ Inhaler technologies

+ Modified release injectable products

+ Biosimilars

AET and generics. At the service of international healthcare systems.

Printed: September 2012

2322

ALFRED E. TIEFENBACHER (GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Phone +49 (0) 40 - 44 18 09 - 0

Fax +49 (0) 40 - 44 18 09 - 26

Mail info@aet.eu

Web www.aet.eu