fully funded drug development & innovation

WE TRANSFORM YOUR MOLECULE INTO A REGISTERED DRUG

D E B I O P H A R M G R O U P ™

Debiopharm Group™ (Debiopharm) is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs targeting unmet medical needs. The group in-licenses, develops and/or co-develops promising biological and small molecule drug candidates having reached clinical development phases I, II or III. Debiopharm is also prepared to consider earlier stage candidates. At the end of the development process, the products are out-licensed to pharmaceutical partners for sales and marketing. Besides drug development, Debiopharm is active in the field of diagnostics and personalised medicine. Debiopharm independently funds the worldwide development of all of its products.

HOW DOES DEBIOPHARM HELP ITS PARTNERS ?Expertise _Since its creation in 1979, Debiopharm has accumulated a very comprehensive expertise in the management of pharmaceutical projects with partners. The internal expertise of Debiopharm covers all relevant areas, such as CMC, business intelligence, law/IP, production or regulatory affairs, to mention but a few ;

Quality work _Debiopharm typically looks at 1’000 new opportunities per year. The search and evaluation process is robust and leads to an average of 3 to 5 new partnerships per year ;

Commitment _Once Debiopharm decides to proceed with a project, it engages its fully dedicated professionals and international experts: a group of competent people is built around the project; and the common goal of all those involved is to bring the molecule as quickly as possible to market, in most cases with the support of Scientific Advisory Boards ;

Stability _Thanks to the family structure of Debiopharm, the top management is stable and predictable, which enhances continuity ;

Financial independence, but no complacency _ As privately held company, Debiopharm is not subjected to the same rules and practices as publicly quoted companies. The group nevertheless follows some of the key processes applying to listed companies. It is for instance maintaining an audit committee and a strategic committee ; Accomplishments _Debiopharm has developed many molecules (such as Debio 025, which was licensed out in 2010) and has brought five products to the market. In developing such molecules, the group has conducted over 70 clinical trials in 20 countries worldwide. These trials have been performed in several therapeutic areas such as oncology, infectious diseases, neurology, endocrinology, gastroenterology or pulmonary diseases.

DEBIOPHARM AND ITS LEGAL ENVIRONMENTDebiopharm is committed to working according to state-of-the-art methods and in strict compliance with applicable regulations. Quality is actively fostered by the Debiopharm shareholders as well as by every employee of every company of the group.

THE FUTUREThe key challenges to the pharmaceutical industry are to use scarce financial resources in the most efficient way and to ensure quality, access and sustainability all over the world. Against this background, Debiopharm wants (a) to develop cost-effective drugs, (b) to develop its diagnostic arm, (c) to redesign molecules, and (d) to enhance patient access in emerging economies.

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D E B I O P H A R M G R O U P ™

B U S I N E S S S T R A T E G Y & M O D E L

C A P A B I L I T I E S

P A R T N E R I N G

W I T H D E B I O P H A R M G R O U P ™

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T H E P A T I E N T I S P R E S I D E N T

Welcome to Debiopharm Group™, where the patient is President ! Through successful partnerships we have built a truly leading global biopharmaceutical development group. Our professionals provide the passion and inspiration to bring important new medicines to market. Our marketed products provide us with the financial resources to maintain a robust pipeline of promising drug candidates; and our partners’ new discoveries fuel our pipeline with innovative small molecules, biologics and siRNAs.

Since 1979, our drug development experience, project management expertise and financial strength have enabled us to take full entrepreneurial responsibility for product development through to regulatory approval. Because of our unique size and private status, we are able to pursue a wide variety of projects and establish partnerships where our interests are closely shared.

We have now built a team of well over 300 dedicated professionals and a vast international network of external experts that can support all the development work pertaining to the projects for the time being in our pipeline. Our team’s objective is to bring innovative drugs to the market rapidly, through a focused and multidisciplinary approach, capitalising on the experience, creativity and intelligence of our staff and network. We strongly believe that success comes not only from our technical expertise, but also from the creativity, passion and tenacity of our team.

Social and corporate responsibility is part of our ethical standards. To contribute to the health of our planet, we continually review and improve our efforts to reduce the burden on our environment. It is our wish that we build our scientific and business decisions on actions geared towards sustainable development, including social, environmental and economic issues.

We are looking to be your partner of choice, taking on full financial and managerial responsibility for your entire project, while sharing in the success together.

Thierry B. Mauvernay Dr Rolland-Yves MauvernayExecutive Vice President President & Founder

A Unique Business Model for Success :

in-license, add value through innovative R&D strategy and implementation,

out-license and maximise commercialisation potential

B U S I N E S S S T R A T E G Y & M O D E L

We are a highly focused drug development organisation, successfully bring ing novel bio-pharmaceuticals to market.

Our business strategy is to partner through the in-licensing of therapeutic products from bio-technology, pharmaceutical and academic organisations worldwide. We develop or co-develop the products while paving the way to global registration and we carefully select optimal marketing partners to maximise commercialisation.

Pharma

market

from molecule v a l u e a d d e d to drug approval

discovery DEBIOPHARM GROUP™

fully funded drug development

& innovation

Academic institutionsBiotechStart upPharma

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The worldwide healthcare environment is changing. The key trends are twofold : first, an increasing demand for reasons such as demographics, the frequency of chronic conditions, technological advances and improved access to healthcare in emerging countries, and second, financial constraints. Given these constraints, one needs to develop strategies enabling a more efficient use of scarce financial resources. One of these strategies consists in reducing the percentage (currently ca 50%) of drugs not acting according to expectations.

Against this background, Debiopharm Group™ is building its future on the following four pillars :

:: development of molecules, as described above ;

:: redesign of molecules, with a view to enhancing their safety and/or efficacy profile ;

:: companion diagnostics, in order to progress in the area of personalised medicine ; and

:: emerging economies, to improve patient access to innovative medicines.

Debiopharm Group™ adapts to a changing

healthcare environment

Enhancing the development process

of biopharmaceuticals

We bring together over 30 years of expertise and dedicated multidisciplinary teams to achieve timely regulatory- and market-driven pharmaceutical development programmes. Our experience has been validated by the rapid development and out-licensing of five commercially successful products that are top performers in their specific therapeutic areas : Eloxatin®/Elplat®, three formulations (1-month, 3-month and 6-month) of Decapeptyl®/Trelstar®/Pamorelin® as well as Moapar®/Salvacyl® 3-month.

By maximising the commercial potential of all our partnered therapeutic products, we are not only able to share in the success with our partners, but also to reinvest the commercial proceeds into the development of a new generation of products and partnerships.

In addition to our strengths in clinical drug development, we have a great deal of expertise in :

:: planning product life cycles through proprietary drug delivery and formulation technologies already during development ;

:: continued investment and focus on ongoing innovations ;

:: expansion and protection of intellectual property rights.

Preclinical and Clinical Expertise

The professionals working for Debiopharm Group™ have a broad clinical and medical expertise that encompasses the whole spectrum of drug discovery and (co)development including proof of principle studies, Phase l and Phase ll studies, Phase lll pivotal trials, compassionate drug use and Phase lV programmes. Our clinical experience is extensive and diverse, covering therapeutic areas such as oncology, infectious diseases, neurodegenerative disorders, metabolic diseases and immune-mediated diseases.

Over 70 clinical trials have been managed and performed by Debiopharm Group™ in 20 countries worldwide.

Global Regulatory and Registration Know-How

The foundation behind commercial success is a well planned international product regulatory and registration strategy. With Europe and the US now representing over 70% of the world pharmaceutical market and the dynamic emerging economies (Brasil, Russia, India and China, to mention but a few), a truly global strategy must be designed. Our team understands the fundamental procedures, issues and initiatives that will have an impact on regulatory success in all major markets. From the start, we focus on the integration of all project leaders, outside advisors and experts to ensure that manufacturing, preclinical and clinical studies comply with all relevant regulations in e.g. the EU, the US and Japan.

C A P A B I L I T I E S

Pharmaceutical Development and Strong Manufacturing Capabilities

Pharmaceutical development involves active pharmaceutical ingredients (API) and formulated drug products for preclinical studies, clinical Phases I to III and commercial scale. Our know- how covers API and drug product manufacturing, analytical method development and validation, quality control as well as packaging and supply chain. We have extensive experience in managing these activities on an internal as well as contract-out basis and we have built an international network of partners that we work with.

From producing consistent small batches for feasibility studies, through clinical trial supplies and onto commercial scale manufacturing, we have extensive experience with both small molecule pharmaceuticals and biologics. Throughout the entire chain, we develop, conduct and control production processes to ensure that our products conform to specifications and respect international cGLP and cGMP guidelines. Our production facility in Switzerland has undergone US FDA and Swissmedic inspections.

Innovative Drug Delivery and Formulation

We are considered to have world renowned capabilities in maximising sustained release drug formulations through the application of our advanced drug delivery systems (ADDS) which are based on polylactic-co-glycolic acid (PLGA). Our scientists also have expertise in solubility improvement, nanosystems, innovative formulations (e.g. for vectorisation of cytotoxic drugs) and pegylation technologies to link complex peptides and proteins with other molecules for targeted drug delivery and controlled release.

These technologies have demonstrated in multiple commercial products that they can strengthen the competitive advantage of new chemical entities and biologics by extending the life cycle of important drugs and creating new industrial property opportunities.

Due Diligence / contract

Active Pharmaceutical Ingredient

Drug Product

Pharmacology

Toxicology

Drug Metabolism & PK

GO to Phase I/II

Clinical Phase I/II

Clinical Metabolism & PK

Biomarkers Development

Go to Phase III

Clinical Phase III

Regulatory (IND & NDA)

Approval

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Example of an R&D strategic plan for a development candidate with preclinical proof of concept, according to the desired Target Product Profile

T I M E

What We Can Offer

Our unique size, financial resources and business

model allow us to independently fund and

manage each in-licensed product for success.

Our strategies and tactics aim at offering to

our partners :

:: development and co-development skills

and expertise,

:: maximum return on investment,

:: product sustainability and viability,

:: global commercial success.

P A R T N E R I N G W I T H D E B I O P H A R M G R O U P ™

For biotechnology and pharmaceutical partners,

for academic and research organisations, we offer

flexible deal terms to :

:: monetise the value of their important

discoveries and projects through licensing

fees, milestone payments and royalties

on downstream profits ;

:: fully fund products that lack resources for

their development ;

:: leverage core products into global markets ;

:: tap into the wealth of Debiopharm

Group™ ’s development expertise.

In addition, we validate the technology of our

biotechnology and pharmaceutical partners to

further attract commercial partners. We

furthermore finance early-stage projects

through equity participation. We can also

mitigate the risk and help our partners relieve

their human and financial resources.

Specifically for academic and research

organisations, our commercially orientated

development is an advantage.

Key therapeutic areas :

• oncology• infectious diseases• metabolic diseases• immune-mediated diseases• neurodegenerative disorders

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What We Are Looking For

Our main therapeutic areas are oncology and

infectious diseases, but we are also interested

in selective indications in e.g. the following

therapeutic areas : metabolic diseases, immune-

mediated diseases and neurodegenerative

disorders.

We also have competence in orphan and niche

indications within our therapeutic areas. Products

can include small molecules, exciting biologics

such as proteins (e.g. monoclonal antibodies) or

peptides, and siRNAs.

The products that we develop should have the

best possible safety and efficacy profiles ; and

they should feature positive and promising

in vivo results.

Our evaluation teams are interested in

investigating any drug development candidate

in the therapeutic areas listed above, especially

those that have shown promising results in an

animal model, although we are prepared to

consider earlier stage candidates. We are also

interested in licensing-in development products

that can benefit from our formulation and drug

delivery capabilities.

We have both a stringent and aggressive

evaluation process, with the objective of in-

licensing up to ten new products in three years.

What We Aim At

We aim to have and maintain ten products in

clinical development in our portfolio, of which a

maximum of 50% are biologics and 50% oncology

products.

Since 1979, Debiopharm Group™ has created and

maintained a promising product pipeline. These

products and product candidates have come from

all corners of the world, encompassing different

development phases. Our entire pipeline is made

up of products in most of the above listed

therapeutic areas.

o u r P i P e l i n e

Preclinical

Phase I

Phase II

Phase III

Submitted

Debiopharm Group’s projects cover all types of molecules such as:

proteins (e.g. monoclonal anti-bodies), peptides, small molecules or siRNAs.

For current pipeline please visit www.debiopharm.com

Debio 025 (licenced to Novartis worldwide except Japan), HCV Cyclophilin inhibitor

Debio 025, HCV Cyclophilin inhibitor, Japan

Debio 0932, Oncology Hsp90 inhibitor

Debio 1036, Autoimmune diseases undisclosed target

Debio 0617, Oncology undisclosed target

Debio 0721, Undisclosed target

Debio 0930, Metabolic diseases AMPK activator

Debio 0929, Oncology undisclosed target

Debio 0826, Oncology undisclosed target

Debio 1141, Urothelial carcinoma siRNA

Debio 1142, Oncology undisclosed target

Current pipeline

www.debiopharm.com

The product is key to our success and our partners’ success.

The Debiopharm Group™ network :a wide variety of partners all over the world

NovartisPfizerSanofi-Aventis

AchéDr Reddy’s LaboratoriesIpsenMephaTecnofarmaWatson PharmaceuticalsYakult

BiocartisDiagnoplexEclosionNeoVacsTcLand ExpressionTcL Pharma

AurigeneCurisKirinMercury TherapeuticsMSM Protein TechnologiesTcLand

EPFL (Ecole polytechnique fédérale, Lausanne)Nagoya City UniversityTulane UniversityYale University

Pharmaceutical companiesand star t-ups

Academic institutions

Licensing-in Licensing-outDebiopharm has invested in following companies

O U R N E T W O R K

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©Debiopharm Group™_2011

fully funded drug development & innovation

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www.debiopharm.comFor more information on Debiopharm Group™, please visit www.debiopharm.com

DEBIOPHARM S.A. ,

DEBIOINNOVATION S.A. and

DEBIOMANAGEMENT S.A.

Forum “après-demain”

Chemin Messidor 5-7, CP 5911

1002 Lausanne

Switzerland

Tel. +41 (0) 21 321 01 11

Fax +41 (0) 21 321 01 69

DEBIO RECHERCHE PHARMACEUTIQUE S.A.

Route du Levant 146, CP 368

1920 Martigny

Switzerland

Tel. +41 (0) 27 721 79 00

Fax +41 (0) 27 721 79 01