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Debiopharm Group - Company Profile

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Page 1: Debiopharm Group - Company Profile

we developfor patientsDebiopharm GroupTM

Company Profile – February 2017

Page 2: Debiopharm Group - Company Profile

COMPANY PROFILEAPRIL 2015

2 DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2017

Table of contents

INTRODUCTION 3

DEBIOPHARM GROUP 6

MARKETED PRODUCTS 17

DEBIOPHARM INTERNATIONAL SA 22

DEBIOPHARM RESEARCH & MANUFACTURING SA 26

DEBIOPHARM INVESTMENT SA 31

DEBIOPHARM INNOVATION FUND SA 35

GENEPOC INC 40

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3 DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2017

DEBIOPHARM GROUP™c/o Debiopharm International SAForum “après-demain’Chemin Messidor 5-7CP 5911 – 1002 LausanneSwitzerland

T + 41 (0) 21 321 01 11F + 41 (0) 21 321 01 [email protected] www.debiopharm.com

DEBIOPHARM INVESTMENT SAForum “après-demain’Chemin Messidor 5-7CP 5911 – 1002 LausanneSwitzerlandT + 41 (0) 21 331 29 30F + 41 (0) 21 331 29 [email protected]

DEBIOPHARM RESEARCH & MANUFACTURING SACampus “après-demain”Rue du Levant 1461920 MartignyT + 41 (0)27 721 79 00F + 41 (0)27 721 79 [email protected]

DEBIOPHARM INNOVATION FUND SACampus “après-demain”Rue du Levant 1461920 MartignyT + 41 (0) 21 321 01 11F + 41 (0) 21 321 01 [email protected]

GENEPOC INC.360 rue Franquet, porte 3G1P 4N3 - QuébecT 1 418 [email protected]

FOR ALL ENQUIRIESChristelle TurCommunication CoordinatorDebiopharm International SA

T + 41 (0) 21 321 01 11F + 41 (0) 21 321 01 [email protected]

FOR SWISS MEDIA AND LOCAL PRESS ONLYGiuseppe MelilloConsultant - Press & Public Relations Officer

M + 41 (0) 79 271 04 [email protected]

Contact Information

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4 DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2017

About us

MAIN THRUST

KEY POINTSDebiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in drug de-velopment, GMP manufacturing of proprietary drugs, diagnostics and investment management.Debiopharm Group™ is also referred to hereinafter as ‘Debiopharm’.

Debiopharm is focused on the development of inno-vative prescription drugs that target unmet medi-cal needs. Our main therapeutics areas are oncology, infectious diseases and orphan drugs. Debiopharm in-licenses, develops and/or co-develops promising biological and small molecule drug candidates having reached clinical development phases I or II as well as earlier stage candidates. Debiopharm is also open to purchasing assets in order to develop them.

It develops its products for global registration and access to the largest number of patients worldwide. The products are out-licensed to commercial partners for sales and marketing. Debiopharm is also active in the field of companion diagnostics with a view to

progressing in the area of translational medicine. Debiopharm independently funds the worldwide deve-lopment of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Debiopharm has completed the development of and has licensed out five products, namely, Eloxatin® (Elplat®, Dacotin®, Dacplat®), Decapeptyl® (Trelstar®, Pamorelin®) 1-month, 3-month and 6-month formu-lations, and Moapar® (Salvacyl®). More info pp. 19-21.

For more than 35 years, we have been passionate about what we do: drug development.

Year of foundation 1979

Headquarters Lausanne, Switzerland

Employees 420 employees. More than 70% are scientists (MDs, PhDs, phar-macists). Debiopharm’s employees come from 20 different coun-tries, with ca 57% of women and 43% of men. Debiopharm is supported by 400 external experts, who advise the operational companies in all relevant areas.

Ownership Debiopharm is privately-owned and financially independent. It has no intention of going public and it does not seek venture capital.

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Vision & Mission

OUR VISION

We provide innovative, relevant and accessible therapies for tomorrow’s world, through evidence-based medicine

OUR MISSION

We transform promising molecules into innovative therapies, built on our vision, our scientific excellence and our financial independence

SCIENCE VALUES

FINANCE

WE DEVELOPFOR PATIENTS

CreativityEfficiencyPassion

CommitmentEthicsResponsibility

Innovative science at the core70% scientists

Life cycle management

Family-ownedFinancially independentStrong & stable revenue stream

CORPORATE IDENTITY

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COMPANY PROFILEAPRIL 2015

6 DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2017

Debiopharm Group

HISTORY 7

BUSINESS MODEL 8

PARTNERING OBJECTIVES 10

WHAT DEBIOPHARM IS LOOKING FOR 11

RESEARCH & EVALUATION PROCESS OF MOLECULES 12

PIPELINE & LATEST NEWS 13

DEVELOPMENT PROJECTS 14

ALLIANCES 15

MANAGEMENT 16

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HistoryIn 1979, convinced that many useful therapeutic products were abandoned before reaching their full potential, Dr Rolland-Yves Mauvernay founded the Swiss-based Debiopharm Group™. Thirty years later, he is still driven by the passion of developing innovative therapies for the treatment of serious medical conditions.

Having started with only two people, Dr Mauvernay (Founder & Co-President) now heads with his son Mr Thierry Mauvernay (Co-President & Delegate of the Board) a group of 350 employees with about 400 external consul-tants. Together, they are fully committed to today’s group activities and plan the future to ensure long-term continuity. The two words best describing the strength and energy of Debiopharm are collective intelligence.

AS DR MAUVERNAY SAYS:

Over the years, we have learnt to know when we should stop. Our failures have enabled us to move forward, to identify new paths and to reach for success; but the key of all our achieve-ments is the interconnection between our people and our motivation to develop for patients.

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Business ModelA bridge from discovery to market

SUMMARY

Debiopharm has more than 35 years expertise and dedicated multidisciplinary teams to achieve timely regulatory and market-driven pharmaceutical development programs. Debiopharm’s experience has been validated by the rapid development and out-licensing of the commercially successful products mentioned previously.

LICENSING-IN, DRUG DEVELOPMENT, LICENSING-OUT

Debiopharm has a unique business model. Dr Rolland-Yves Mauvernay decided to build a different company with drug development as its primary focus and passion.

CONCRETELY, DEBIOPHARM ’S CORE ACTIVITIES CONSIST IN:

• Licensing-in new molecules or purchasing clinical assets presenting potentially superior therapeutic pro-perties, following a robust search and evaluation process;

• Taking the in-licensed molecules through the entire development process, i.e. formulation, manufacturing, pre-clinical, clinical and registration;

• Selecting the best commercialization partners to give access to the largest number of patients worldwide.

DRUG DEVELOPMENT

FROM ORIGINATOR TO THE PATIENT THROUGH OUR PARTNERS

DEBIOPHARM GROUP

DRUG PROJECT MARKET

INVE

STM

ENT

INVE

STM

ENT

$ $

2-3 YEARS 10-12 YEARS PRODUCT LIFE

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PRECLINICAL OUR ADDED VALUE

INTERNAL EXPERTISE

VALUABLE DRUG

RESEARCH & EVALUATIONINTELLECTUAL PROPERTYPRECLINICAL DEVELOPMENTMANUFACTURING SCALE-UP

CLINICAL DEVELOPMENTGLOBAL REGULATORYALLIANCE MGTOUTSOURCING MGT

From a molecule Drug DevelopmentExpertise

To the patient

EXTERNALEXPERTS

OUTSOURCINGPARTNERS

DEBIOPHARM DRUG DEVELOPMENT ENGINE

COMPENSATION TO INNOVATORS AND ROYALTIESDebiopharm compensates the innovators of the molecules it licenses in. Once a product is marketed, Debiopharm receives royalties on the product sales that it shares downstream with the inventors. The company has designed creative schemes to make sure that its licensors have a recurrent revenue stream.

BEYOND DRUG DEVELOPMENT Whilst drug development remains its core business, the Group has developed extensive expertise in additional areas, such as applied research (peptides, re-design of molecules), drug delivery, lifecycle management, industrial manufacturing (using proprietary technologies) and companion diagnostics (as a tool to enhance personalized medicine).

FINANCIAL INDEPENDENCE AND STRENGTHDebiopharm is not pressured by outside investors, especially since the Group started generating a robust reve-nue stream from its marketed products. Debiopharm is absolutely free to invest all its creativity and energy into developing the most promising drugs that it decides to in-license. All of those factors have shaped Debiopharm’s very strong identity as a financially independent, fully dedicated and outstanding drug development company.

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Partnering ObjectivesDebiopharm forms partnerships all over the world with academic institutions, laboratories, as well as biotechno-logy and pharmaceutical companies with compounds showing a superior therapeutic potential.

Debiopharm may decide to in-license those compounds and develop them for global registration. Debiopharm finances their entire development up to registration, so as to be in a position to license them out to the most suitable sales and marketing pharmaceutical partners.

Debiopharm contemplates long-term partnerships that cover all the development time (8-15 years), as well as sales and marketing years. To maintain a successful cooperation during all these years, Debiopharm aims at buil-ding trust with these following elements:

Debiopharm in-licenses promi-sing projects and looks to grow them by adding value through its key expertise. When the product is out-licensed, Debio-pharm shares the success with the originator.

Debiopharm is also interested in buying outstanding assets and platforms.

LABORATORY PHARMADRUG DEVELOPMENT

DEBIOPHARM R&M

Out-licensing

Royalties

In-licensing

Royalties

ORIGINATOR

SUBLICENCEEDRUG DEVELOPMENT

Out-licensing

Asset Purchase

Royalties

LABORATORY PHARMADRUG DEVELOPMENT

DEBIOPHARM R&M

Out-licensing

Royalties

In-licensing

Royalties

ORIGINATOR

SUBLICENCEEDRUG DEVELOPMENT

Out-licensing

Asset Purchase

Royalties

IN-LICENSING COLLABORATION MODEL

ASSET PURCHASE MODEL

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What Debiopharm is looking forDebiopharm’s main, but not exclusive, therapeutic areas of interest are oncology, infectious diseases, and immunology.

Debiopharm is interested in evaluating first-in-class or best-in-class drug development candidates in these the-rapeutic areas, especially candidates that have shown promising results in animal models. The Group could also consider earlier stage candidates.

We look at small molecules and biologics.

$

MAIN THERAPEUTIC AREAS:Oncology

Infectious DiseasesImmunology

DEVELOPMENT STAGES:Early & Late Preclinical

Clinical (Phases I, II)

MOLECULES: NCEsNBEs

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Research & Evaluation Process of MoleculesDebiopharm has a robust, rigorous and systematic, but open-minded evaluation and due diligence process. Chosen projects are allocated realistic resources for development.

Its Search and Evaluation staff analyzes ca 1000 new opportunities per year, leading to between 4 and 8 due diligences. This process culminates in 1 to 3 in-licensing deals per year.

Debiopharm has an experienced scouting team and therapeutic area evaluators. They travel travel across the world and attend various partnering conferences in search of new molecules that could fit with the strategy and could potentially lead to new opportunities.

PROSPECTION

Screening

Scoutingteam

EvaluationTeam

BusinessTeam

Advanced Evaluation Term SheetEarly Evaluation Due Diligence Acquisition/Licensing

EVALUATION NEGOTIATION

Mentors

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Pipeline & Latest News

Our pipeline is frequently updated. To read the very last version, please visit: www.debiopharm.com/our-business/pipeline.html

LATEST NEWS

Our latest news are displayed our web site. Please visit: www.debiopharm.com/medias/press-release.htmlFollow us on Twitter, LinkedIn & Facebook

Innovative Projects in Development Discovery Preclinical Phase I Phase II Phase III

Orphan Drug Designation Fast Track Qualified Infectious Disease Product

Debio 1450, ABSSSI, FabI inhibitorDebio 1143, Head & Neck cancer, SMAC mimeticDebio 1143, Ovarian Cancer, SMAC mimeticDebio 1450, Bone & joint infections Fabl inhibitorDebio 1347, Oncology, FGFR1, 2, 3 inhibitorDebio 1143*, NSCLC, SMAC mimeticDebio 025, Musc. Dystrophy, Cyclophilin inhibitorDebio 1453, N. gonorrhoeae, H. pylori, FabI inhibitorDebio 1454, Enteric species, FabI inhibitor

ODD FT QIDP

ODD

QIDP/FT

QIDP/FT

*in combination with avelumab

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Development ProjectsDEBIO 025 is the first in a new class of drugs called cy-clophilin inhibitors, which could be used in many indi-cations. Debio-025 was initially developped in hepatitis C where it demonstrated safety and efficacy in a large number of patients. Debio 025 has the potential for de-velopment in other viral diseases such as hepatitis B, as well non-viral diseases including muscular dystro-phies and Debiopharm is actively investigating develo-ping the molecule in these indications.

DEBIO 1454 is a FabI inhibitor targeting a combination of enteric bacteria species, Enterobacter Spp., Klebsiel-la pneumoniae and E.coli, developed in collaboration with Nobelex. This compound belongs to a family of narrow-spectrum antiobiotics that combines a very potent activity on pathogens of interest while reducing the selective pressure on other bacterial strains and sparing the microbiome.

DEBIO 1450 is a new antibiotic benefiting from both oral and IV formulations. It is a highly potent, staphy-lococcus-selective antibiotic with a low propensity to emergence of resistance. This first-in-class FabI inhi-bitor retains its activity on staphylococci resistant to antibiotics currently in clinical use including beta lac-tams, vancomycin, daptomycin or linezolid. Debio 1450 completed a Phase II study in ABSSSI in October 2016 and is perfectly suited to tackle several additional hard-to-treat infections caused by staphylococci.

DEBIO 1143 is an oral chemo-radiosensitizer that will improve cancer patient treatment outcomes. It is a small molecule that neutralizes major inhibitors of apoptosis by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC). Evasion of apoptosis is a hallmark of cancer and a common mechanism of resistance to current treatements through deregulated expression of the family of inhibitor of apoptosis proteins (IAPs). Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian, NSCLC and Breast cancer.

DEBIO 1347 is an orally available small molecule tar-geting FGFR 1, 2, 3 signaling pathways. Debio 1347 is currently in phase I for the treatment of advanced solid tumors. It already showed anti-cancer efficacy in se-veral in vivo preclinical animal models. Debio 1347 is expected to become a tailored treatment which will be developed with a companion diagnostic.

DEBIO 1453 is a FabI inhibitor specifically targeting N. gonorrhoeae developed in collaboration with Nobelex. This compound belongs to a family of narrow-spec-trum antiobiotics that combines a very potent activity on pathogens of interest while reducing the selective pressure on other bacterial strains and sparing the mi-crobiome.

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Alliances

At Debiopharm, we rely on dedicated alliance managers to look after our partners.

COMPANY DESCRIPTION

Aché Laboratórios Farmacêuticos SA Commercial partner for Triptorelin in Brazil (Neo Decapeptyl®)

Allergan Commercial partner for Triptorelin in North America (Trelstar®)

Arbor Pharmaceuticals, LLC Commercial partner for Triptorelin in the US for CPP

Ascenta Health Ltd. Collaboration on development of Debio 1143

Chugai Pharmaceuticals CO., Ltd. Collaboration on development of Debio 1347

Dr. Reddy’s Laboratories Commercial partner for Triptorelin in India (Pamorelin®) and Oxaliplatin (Dacotin®)

Ferring Pharmaceuticals Center SA Commercial partner for Triptorelin in Israel (Decapeptyl®)

Ipsen Commercial partner for Triptorelin in more than 60 countries (Decapeptyl® and Pamorelin®)

Nagoya City University Eloxatin licensed in 1989

Orient EuroPharma Co., Ltd. Commercial partner for Triptorelin in Singapore (Pamorelin®)

Pfizer AG Commercial partner for Oxaliplatin in Argentina (Dacplat®)

Sanofi Commercial partner for Oxaliplatin (Eloxatin®) in most of the world, including America, Europe, CIS and Asia

Solid Biosciences, LLC Collaboration on Debio 025

Tecnofarma SA Commercial partner for Triptorelin in Latin America, except Brazil (Decapeptyl®)

Tulane University Licensing agreement for Triptorelin in 1982

United Laboratories Inc. Commercial partner for Triptorelin in the Philippines (Pamorelin®)

Vifor Pharma SA Commercial partner for Triptorelin in Switzerland (Pamorelin®)

Yakult Honsha Co., Ltd. Commercial partner for Oxaliplatin in Japan (Elplat ®)

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ROLLAND-YVES MAUVERNAYCo-President & Founder, Debiopharm Group™

THIERRY MAUVERNAYCo-President & Delegate of the Board, Debiopharm Group™

Management of Debiopharm Group

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17 DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2017

Marketed Products

WHAT WE DO: CRITICAL ACHIEVEMENTS 18

ELOXATIN®, ELPLAT®, DACOTIN®, DACPLAT® (OXALIPLATIN) 19

DECAPEPTYL®, TRELSTAR®, PAMORELIN®, 20 NEO DECAPEPTYL® (TRIPTORELIN)

SALVACYL®, MOAPAR® (TRIPTORELIN) 21

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What we do: Critical Achievements

Compounds

Successful marketed products

OxaliplatinTriptorelin

Eloxatin®: Gold standard & blockbuster

Decapeptyl® : 3 sustained-release formulations (1, 3, 6 months)

Salvacyl®

2

5

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A major advance in the history of cancer treatment

Eloxatin®, Elplat®, Dacotin®, Dacplat® is an anti-cancer drug belonging to the class of platinum-based compounds. Its active substance oxa-liplatin is a diaminocyclohexane (DACH) platin that was licensed in at phase I from Nagoya University in 1989.

Debiopharm added value to the molecule by developing it and working in particular on its efficacy-safety ratio. Debiopharm first submitted the Eloxatin® file in France for registration.

Triptorelin was discovered by Profes-sor Andrew Schally, who received the Nobel Prize in 1977 for his discovery.

It is a worldwide gold standard treatment in metastatic colorectal cancer.

1996 First approval of the lyophilised for-mulation obtained in Europein 1996 within seven years of in-licensing

2002 Record 46-day Food and Drug Admi-nistration (FDA) approval in 2002 in the United States

2005 Approval in Japan in 2005 (Elplat®)

Approval of the aqueous formulation in 2005 in the US

2006 Approval of the aqueous formulation in 2004 in France, in 2005-2006 in most other European countries

2009 Approval of the aqueous formulation in Japan in 2009

2015 Gastric cancer approval in Japan in 2015

ELOXATIN®, ELPLAT®, DACOTIN®, DACPLAT® (OXALIPLATIN)

IN SHORT

ACHIEVEMENTS

DEBIOPHARM VALUE ADDED

Identification of the first clinical indication (mCRC)

Optimization of the efficacy-safety profile

Clinical development leading to the first file sub-mission registration in France

CMC Continuous life cycle management (ie: solu-tion formulation)

15 patent families covering process, combination, formulation and use

x2

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1986 European approval was obtained in 1986 within 4 years of in-licensing.

1986 Three formulations available, which provides several options to the health practitioners.

Triptorelin is a gonadotropin releasing hormone (GnRH) agonist

Decapeptyl® is a gonadotropin-releasing hormone (GnRH) agonist analogue that was licensed-in at late preclinical stage from Tulane University in 1982. Debiopharm added value to the molecule by developing the 1-, 3- and 6-months sustained release formulations commercialized by its partners in Europe and the US.

Decapeptyl® was the first sustained release formulation of a GnRH agonist to be approved in the world.

DECAPEPTYL®, TRELSTAR®, PAMORELIN®, NEO DECAPEPTYL® (TRIPTORELIN)

GnRH discovered by Professor Andrew Schally (1971 - Tulane University), who received the Nobel Prize in 1977 for his discovery. The first synthesis of GnRH agonist Triptorelin by Professor Andrew Schally was in 1973.

Triptorelin is number one product of Ipsen in 2014.

Development and registration of the triptorelin 1-, 3- and 6-month sustained release formula-tions in Europe, in North America and the rest of the world.

Continuous life cycle management (new formula-tions, route of administration, indications).

First worldwide registered sustained release formulation of a gonadotropin releasing hormone (GnRH) agonist in 1986.

IN SHORT

ACHIEVEMENTS

DEBIOPHARM VALUE ADDED

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SALVACYL®, MOAPAR® (TRIPTORELIN)Moapar® 11.25mg is the first 3 months injectable formulation, prescribed for a reversible reduction of serum testosterone to the level of castration in adult men suffering from sexual deviations. Developed by Debiopharm, Moapar® contains a gonadotropin releasing hormone (GnRH) agonist analogue.

ACHIEVEMENTS

2006 The paraphilia indication was approved in 2006.

2009 The product is licensed in ten European countries, including France, Germany, the United Kingdom, Sweden, Norway, Den-mark, Belgium, the Netherlands, Finland and Switzerland. The product was launched in 2009 in Germany and Belgium and since then in several EU countries.

FACTS ABOUT SALVACYL®, MOAPAR®

• Indication: treatment of severe cases of paraphilia, in combination with psychotherapy

• Licensed to Ipsen

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Debiopharm International SAINTRODUCTION 23

MANAGEMENT 24

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Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses, develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients world-wide.

ESPACE ‘APRÈS-DEMAIN’ - EPFLDebiopharm International SA also has a team based on the EPFL campus (Ecole polytechnique fédérale de Lausanne). Our Espace ‘après-demain’ is part of our Translational Medicine Department. The main activities on the campus are :

• Translational Laboratory supporting Drug Discovery and Advanced Pro-ducts

• Preliminary DMPK characterization (ADME and bioanalytics)

• Applied Bioresearch supporting biomarker and drug activity assessment

Debiopharm International SA

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BERTRAND DUCREYChief Executive Officer, Debiopharm International S.A.

CHRISTINE DEUSCHELVice President, Portfolio & Project Management, Debiopharm International S.A.

NIGEL MCCRACKENVice President, Translational Medicine, Debiopharm International S.A.

JEFFERY S. VICKVice President,Business Development & Licensing, Debiopharm International S.A.

MANUELA PERRAUDINDirector, Human Resources, Debiopharm International S.A.

Management of Debiopharm International SA

PEGGY LIPPDirector, Regulatory Affairs, Business Intelligence &Market Access,Debiopharm International S.A.

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MANAGEMENT OF DEBIOPHARM INTERNATIONAL SA

VANESSA CURRATDirector, Legal Affairs, Debiopharm International S.A

CHRIS FREITAGVice-President, Clinical Research & Development, Debiopharm International S.A.

ALEXANDRE MARETDirector Finance and Administration, Debiopharm International S.A.

HOUSSAM IBRAHIMVice President,Pharmaceutical Development, Debiopharm International S.A.

THANH LIEM VUDirector Quality Management & Documentation, Debiopharm International S.A.

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Debiopharm Research & Manufacturing SA

INTRODUCTION 27

SCIENCE & TECHNOLOGY 28

MANAGEMENT 29

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Debiopharm Research & Manufacturing SA is a pharmaceutical research, development and production faci-lity, inspected and registered with the main regulatory authorities. Debiopharm Research & Manufacturing’s activities at a glance:

• Chemical Synthesis

• Drugability & Fingerprinting

• Formulation Development

• GMP Manufacturing (FDA, ANVISA, Swissmedic)

Debiopharm Research & Manufacturing SA

• Development & manufacturing of innovative pharmaceutical products

• Use of cutting-edge technologies

• Environmental-friendly manufacturing

Competencies in R&D and production of poorly soluble pharmaceutical API

Expertise in sustained release formulations• Infrastructure• 1000m2 cleanroom• 20’000m2 available land

5 buildings

Our central location in Europe

Low human resources turnover

OUR MISSION

OUR VISION & GOALS

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Science & Technology

PLGA PROPRIETARY TECHNOLOGY

Debiopharm Research & Manufacturing is a recognized world leader in polylactic-co-glycolic acid (PLGA)-based injectable, sustained-release technology, which achieved prominence in 1986 with the launch of the drug Decapeptyl®, a novel injectable controlled-release formulation of triptorelin - a gonadotropin-releasing hormone GnRH agonist analogue. This mode of administration developed by the company relies on the active substance being «wrapped» in a PLGA polymer to allow gradual dissolution and distribution of the active substance in the patient’s body.

Using this technology, formulations achieved can have an adjustable release profile of the active principle in the patient from 1 week to 6 months. Debio® PLGA is suitable for the formulation of low molecular weight drugs and peptides.

Products developed with the Debio® PLGA proprietary technology and that have been approved and are successful on the market in Europe and the U.S. include Decapeptyl®, Trelstar®, Pamorelin® Depot (1-month), Decapeptyl®, Trelstar®, Pamorelin® LA (3-month) and Decapeptyl®, Trelstar®, Pamorelin® LA (6-month).

Another major achievement of Debiopharm in the drug formulation area has been the invention of a new liquid formulation of Eloxatin®, Elplat® (containing oxaliplatin as active ingredient), which does not require reconstitu-tion prior to dilution and administration, is therefore ready to use and of greater convenience.

Other advanced drug delivery technologies are currently in development at Debiopharm.

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CÉDRIC SAGERChief Executive Officer, Debiopharm Research & Manufacturing S.A.

YVES GALYLogistics & Strategic Planning Director, Debiopharm Research & Manufacturing S.A.

ANNE MARGUERETTAZRegulatory, Optimization and Industrialization Director, Debiopharm Research &Manufacturing S.A.

VINCENT GRIFFOULTechnical Services & Process Improvement Director, Debiopharm Research & Manufacturing S.A.

MARIE-ANNE BARDETProject Management & Scientific Director, Debiopharm Research & Manufacturing S.A.

PATRICK GARROUSTEPharmaceutical Development Director, Debiopharm Research & Manufacturing S.A.

Management of Debiopharm Research & Manufacturing SA

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MANAGEMENT OF DEBIOPHARM RESEARCH & MANUFACTURING SA

OLIVIER IMBODENAdministration & HR Director, Debiopharm Research & Manufacturing S.A.

THANH LIEM VUQuality Assurance Director, Debiopharm Research & Manufacturing S.A.

MARCO SALVAGNIDirector of Operations, Debiopharm Research &Manufacturing S.A.

MORENO CENTELLEGHETechnical Service Director, Debiopharm Research & Manufacturing S.A.

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Debiopharm Investment SA

INTRODUCTION 32

EXISTING COMPANIES PORFOLIO 32

MANAGEMENT 34

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FINANCIAL DEPARTMENT

• Cash management

• Currency hedging

• Global balanced portfolio management

• Risk management

REAL ESTATE DEPARTMENT

• Investing in residential and/or commercial real estates, property and facility mana-gement.

• Dedicated to buy, build and develop new estates in har-mony with our values

PRIVATE EQUITY

Investment Diversification

• Equity investment in small and medium companies

• Commitment in Funds

The main objectives are the preservation of the Group’s capital as well as the generation of regular financial incomes for Debiopharm’s companies.

DEBIOPHARM INVESTMENT’S ACTIVITIES

The company is divided into three departments.

Debiopharm Investment SA

DESCRIPTIONCOMPANY

76MW wind farm in Southern Sweden - one of the best areas for onshore wind in Europe.

ACTIVE INVESTMENTS

Global leading provider of innovative business software solutions based on Microsoft (MS) SharePoint technologies.

Spinoff of the Empa and the ETH Zurich.Development of intelligent bed systems for the treatment and prevention of pressure ulcers.

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DESCRIPTIONCOMPANY

CoorpAcademy develops and produces MOOCs (Massive Open Online Courses) solutions for corporate clients.

One of the main solar operators in France with an installed capacity of about 70 MW.

One of the Top 5 International Bilingual School (French-English) in Western Switzerland with 600+ students aged 3 to 18 representing 45 nationalities. The school is accredited by the Council of International Schools and offers the International Baccalaureate programs.

Advanced online authentication solution based on face recognition.KeyLemon

aloe energy

REALIZED INVESTMENTS

COMPANY DESCRIPTION

Offer its clients access to the highest number of resorts with a single card.

Portfolio of renowned Parisian « Grandes Brasseries » (Le Procope, La Lor-raine, Le Grand Café Capucines, Au Pied de Cochon, Flora Danica et Copen-hague Champs-Élysées).

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ALEXANDRA LE COZ SANCHEZDirector, Private Equity Department, Debiopharm Investment S.A.

SOPHIE GENECANDDirector, Real Estate Department, Debiopharm Investment S.A.

VALÉRIE CALVAYRACCEO, Debiopharm Investment S.A.

SAMUEL MOULINChief Investment Officer, Financial department, Debiopharm Investment S.A.

Management of Debiopharm Investment SA

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Debiopharm Innovation Fund SA

INTRODUCTION 36

PORTFOLIO 37

MANAGEMENT 38

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Debiopharm Innovation Fund is the strategic investment fund of the Debiopharm Group. We invest in young innovative companies in the following areas:

• Smart data (pilot or early commercial stage)

• Therapeutics ( discovery and early development)

• Diagnostics (development stage)

with a focus on technologies related to Debiopharm Group’s therapeutic areas of interest, oncology and infectious disease.

Debiopharm Innovation Fund SA

Debiopharm Innovation Fund’s objective is to make strategic investments in innovative companies with techno-logies and business models that change the way we develop drugs and treat patients.

We bring value to our portfolio companies through our knowledge in medicine, pharmaceutical development, regulatory/reimbursement aspects, management and expertise in bringing products to market. We drive our portfolio investments to successful exits.

OUR MISSION

OUR OBJECTIVEMake new investments in companies developing innovative therapeutics, diagnostics, and smart data solutions with a spirit of partnership. Our goals are:

• Long term value creation

• Minority participation

• Advising and helping with technical and business operations

• Active in the Board of Directors

• Exit strategy linked to the product progress

OUR INVESTMENT CRITERIA OUR ACHIEVEMENTS• Experienced management team

• Innovative technology

• Fit with Debiopharm Group’s interests

• Strong execution plan

• Over USD 95 million invested since 2008

• Cumulative equity raised by all companies: USD 500 million

• Debiopharm Diagnostics led 10 out of the 14 last investment rounds

• Progress to date: 4 companies with commercial products, one M&A and one IPO.

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DESCRIPTIONCOMPANY STAGE

Signatures to guide cancer treatment. Prognostic tests for cancer severity and recurrence

Point of care turn-key Dx platforms. Instruments and cartridges for simple and rapid molecular diagnostics

On the market since 2004 (Europe) and 2008 (USA)

Idylla platform and first test launched in Sept. 2014. Successful IPO on Euronext in April 2015

DEBIOPHARM INNOVATION FUND’S PORTFOLIO

Life science platform. It helps translate breakthrough science into drugs by providing an incubator and resources for young biotechs

Immunomodulation in autoimmunity and transplantation

Potential life-saving detection of sepsisHost response signature for early identification of sepsis

2 clinical stage programs, several preclinical programs

Late-stage development phase

Blood-based Colorectal Cancer screeningSignature for colorectal cancer used to determine the need for coloscopy

Market entry through collaboration with Novigenix in 2014

4 portfolio companies, three in cli-nical stage, one IPO. One merger with a public company.

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Focused on active immunotherapy for autoimmune and inflammatory diseasesInitial public offering (IPO) in 2010

New solutions for MDx pretreatmentSample preparation technologies for molecular diagnostics

Current vaccine development efforts are in Crohn’s disease, rheumatoid arthritis and lupus. In Phase IIb/III

Development phase of magnetic bead handling technology

DESCRIPTIONCOMPANY STAGE

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THIERRY MAUVERNAYCo-President & Delegate of the Board Debiopharm Group™

TOM GIBBSDirectorDebiopharm Innovation Fund S.A.

TANJA DOWEHead ofDebiopharm Innovation Fund S.A.

Management of Debiopharm Innovation Fund SA

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GenePOC Inc.

INTRODUCTION 41

MANAGEMENT 42

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POINT OF CARE MDX PLATFORM FOR INFECTIOUS DISEASEGenePOC Inc. develops affordable, rapid molecular tests to identify infectious agents in point-of-care settings. Its mission is to empower healthcare professionals and patients with affordable, simple, and rapid Point of Care (POC) molecular diagnostic tests for infectious diseases.

GenePOC Inc.

• Automated POC system

• Results in less than 1 hour

• Up to 8 different samples tested simultaneously

• Up to 12 targets per sample

• Cost-effective instrument and disposables

TECHNICAL BUSINESS

• Founded in 2007 by Prof. Michel G. Berge-ron of the Centre de Recherche en Infectio-logie (University of Laval, Québec)

• First investment of Debiopharm Diagnos-tics in January 2015, entered Debiopharm Group when a majority stake was taken in July 2016

• Market entry Fall 2016

• Infectious disease test menu, initial focus on hospital acquired infections

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PATRICE ALLIBERTChief Executive Officer,GenePOC Inc.

Management of GenePOC Inc.