Debiopharm Group Corporate Profile

we develop
for patients
Debiopharm GroupTM
Company Profile – February 2016
COMPANY PROFILE
APRIL 2015
Table of contents
INTRODUCTION3
DEBIOPHARM GROUP
6
MARKETED PRODUCTS
18
DEBIOPHARM INTERNATIONAL SA
23
DEBIOPHARM RESEARCH & MANUFACTURING SA 27
DEBIOPHARM INVESTMENT SA
33
DEBIOPHARM DIAGNOSTICS SA
37
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Contact Information
DEBIOPHARM GROUP™
c/o Debiopharm International SA
Forum “après-demain’
Chemin Messidor 5-7
CP 5911 – 1002 Lausanne
Switzerland
T + 41 (0) 21 321 01 11
F + 41 (0) 21 321 01 69
[email protected]
www.debiopharm.com
DEBIOPHARM INVESTMENT SA
Forum “après-demain’
Chemin Messidor 5-7
CP 5911 – 1002 Lausanne
Switzerland
T + 41 (0) 21 331 29 30
F + 41 (0) 21 331 29 31
[email protected]
FOR ALL ENQUIRIES
Christelle Tur
Communication Coordinator
Debiopharm International SA
T + 41 (0) 21 321 01 11
F + 41 (0) 21 321 01 69
[email protected]
FOR SWISS MEDIA AND LOCAL PRESS ONLY
Giuseppe Melillo
Consultant - Press & Public Relations Officer
M + 41 (0) 79 271 04 95
[email protected]
DEBIOPHARM
RESEARCH & MANUFACTURING SA
Campus “après-demain”
Rue du Levant 146
1920 Martigny
T + 41 (0)27 721 79 00
F + 41 (0)27 721 79 01
[email protected]
DEBIOPHARM DIAGNOSTICS SA
CP 187 – 1752 Villars-sur-Glâne
[email protected]
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
About us
For more than 35 years, we have been passionate about what we do:
drug development.
KEY POINTS
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of four companies active in drug
development, GMP manufacturing of proprietary drugs, diagnostics and investment management.
Debiopharm Group™ is also referred to hereinafter as ‘Debiopharm’.
Year of foundation
1979
Headquarters
Lausanne, Switzerland
Employees
350 employees. More than 70% are scientists (MDs, PhDs, pharmacists). Debiopharm’s employees come from 20 different countries, 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.
MAIN THRUST
Debiopharm is focused on the development of innovative prescription drugs that target unmet medical needs. Our main therapeutics areas are oncology,
infectious diseases and immunology. 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
4
DEBIOPHARM GROUP - COMPANY PROFILE progressing in the area of translational medicine.
Debiopharm independently funds the worldwide development 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 formulations, and Moapar® (Salvacyl®). More info pp. 19-21.
FEBRUARY 2016
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
CORPORATE IDENTITY
VALUES
SCIENCE
Creativity
Efficiency
Passion
Innovative science at the core
70% scientists
Life cycle management
WE DEVELOP
FOR PATIENTS
FINANCE
Family-owned
Financially independent
Strong & stable revenue stream
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Commitment
Ethics
Responsibility
COMPANY PROFILE
APRIL 2015
Debiopharm Group
HISTORY7
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
ALLIANCES16
MANAGEMENT 17
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
History
In 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 two people, himself and his secretary, Dr Mauvernay today heads a group of well over 350
employees. Dr Mauvernay projects himself into the future and wants to contribute to building the ‘après-demain’
(the ‘day after tomorrow’) of medicine. His convictions remain unchanged, he values family and humbleness.
AS HE SAYS:
The two words best describing the strength and energy of Debiopharm are collective intelligence.
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 achievements is the interconnection between our people and our
motivation to develop for patients.
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Business Model
A 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 properties, 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.
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
DEBIOPHARM DRUG DEVELOPMENT ENGINE
RESEARCH & EVALUATION
CLINICAL DEVELOPMENT
INTELLECTUAL PROPERTY
GLOBAL REGULATORY
PRECLINICAL DEVELOPMENT
ALLIANCE MGT
MANUFACTURING SCALE-UP
OUTSOURCING MGT
INTERNAL EXPERTISE
OUTSOURCING
PARTNERS
EXTERNAL
EXPERTS
PRECLINICAL
OUR ADDED VALUE
VALUABLE DRUG
From a molecule
Drug Development
Expertise
To the patient
COMPENSATION TO INNOVATORS AND ROYALTIES
Debiopharm 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 STRENGTH
Debiopharm is not pressured by outside investors, especially since the Group started generating a robust revenue 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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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Partnering Objectives
Debiopharm forms partnerships all over the world with academic institutions, laboratories, as well as biotechnology 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 building trust with these following elements:
IN-LICENSING
COLLABORATION
MODEL
Debiopharm in-licenses promising projects and looks to grow
them by adding value through
its key expertise. When the
product is out-licensed, Debiopharm shares the success with
the originator.
Royalties
Royalties
Royalties
Royalties
DRUG DEVELOPMENT
DEBIOPHARM R&M
LABORATORY
PHARMA
DRUG DEVELOPMENT
DEBIOPHARM R&M
LABORATORY
PHARMA
In-licensing
Out-licensing
In-licensing
Out-licensing
ASSET PURCHASE
MODEL
Royalties
Royalties
Debiopharm is also interested in
buying outstanding assets and
platforms.
DRUG DEVELOPMENT
DRUG DEVELOPMENT
ORIGINATOR
Asset Purchase
ORIGINATOR
Asset Purchase
Out-licensing
Out-licensing
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
SUBLICENCEE
SUBLICENCEE
What Debiopharm is looking for
Debiopharm’s main, but not exclusive, therapeutic areas of interest are oncology, infectious diseases,
and immunology.
MAIN THERAPEUTIC AREAS:
Oncology
Infectious Diseases
Immunology
DEVELOPMENT STAGES:
Early & Late Preclinical
Clinical (Phases I, II, III)
$
MOLECULES:
NCEs
NBEs
Debiopharm is interested in evaluating first-in-class or best-in-class drug development candidates in these therapeutic 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.
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Research & Evaluation Process of Molecules
Debiopharm 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.
PROSPECTION
Screening
Scouting
team
Early Evaluation
EVALUATION
Advanced Evaluation
Mentors
NEGOTIATION
Due Diligence
Term Sheet
Evaluation
Team
Acquisition/Licensing
Business
Team
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.
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Pipeline & Latest News
Innovative Projects in Development
Discovery
Debio 8206, Central Precocious Puberty, GnRH agonist
Preclinical
Phase I
Phase II
Phase III
ODD
Debio 025, Alisporivir, HCV, Cyclophilin inhibitor
Debio 1450, ABSSSI, FabI inhibitor
QIDP/FT
Debio 1143, Head & Neck cancer, SMAC mimetic
Debio 1450, Undisclosed indication, Fabl inhibitor
QIDP/FT
Debio 1143, Ovarian cancer, SMAC mimetic
ODD
Debio 1347, Oncology, FGFR1, 2, 3 inhibitor
Debio 025, Musc. Dystrophy, Cyclophilin inhibitor
Debio 0930B, Metabolic disorders, AMPK activator
Debio 1453, N. gonorrhoeae, H. pylori, FabI inhibitor
Debio 1454, Enteric species, FabI inhibitor
ODD
Orphan Drug Designation
FT
Fast Track
QIDP
Qualified Infectious Disease Product
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.html
Follow us on Twitter, LinkedIn & Facebook
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Development Projects
G-SOX Clinical phase III study in advanced and
untreated gastric cancer comparing the combination of
oxaliplatin and S-1 vs. the combination of cisplatin and
S-1. This study in conducted by Yakult, our licensee in
Japan.
DEBIO 8206 is a synthetic decapeptide gonadotropin-releasing hormone (GnRH) agonist analogue. Chronic administration of triptorelin causes down regulation of the pituitary GnRH receptors and suppresses
gonadotropin (LH and FSH) secretion and finally the release of gonadal sex-hormones. The goal of triptorelin
therapy in the indication of central precocious puberty
(CPP) is to avoid compromised adult height, as well as
the social and psychological difficulties associated with
premature sexual development.
The current phase III study investigates the efficacy,
safety, and PK of two intramuscular injections of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in children with CPP. The reduced injection frequency of the proposed 6-month formulation intends
to improve compliance in a pediatric indication for
which no other 6 month GnRH agonist formulation is
approved.
DEBIO 025/ALISPORIVIR is the first in a new class of
drugs called cyclophilin inhibitors, which could be used
in many indications. 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 development in other viral diseases
such as hepatitis B, as well non-viral diseases including muscular dystrophies and Debiopharm is actively
investigating developing the molecule in these indications.
DEBIO 1454 is a FabI inhibitor targeting a combination
of enteric bacteria species, Enterobacter Spp., Klebsiella 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.
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DEBIOPHARM GROUP - COMPANY PROFILE DEBIO 1450 is a prodrug of Debio 1452 benefiting from
both oral and IV formulations. It is a highly potent, staphylococci-specific antibiotic with a very low propensity to resistance emergence. This new FabI inhibitor
entered into Phase II ABSSSI in May 2015 and is perfectly suited to tackle several additional hard-to-treat
Staphylococci-related infections.
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 targeting 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 several in vivo preclinical animal models. Debio 1347 is
expected to become a tailored treatment which will be
developed with a companion diagnostic.
DEBIO 0930B is an oral direct activator of AMPK (adenosine monophosphate activated protein kinase) for
the treatment of diabetes and metabolic diseases. Debio 0930 demonstrated a dramatic impact on fasting
blood glucose levels and lipid profiles in preclinical models. This potential first-in-class compound benefits
from a straight forward synthesis and is currently in
lead optimization phase.
DEBIO 1453 is a FabI inhibitor specifically targeting N.
gonorrhoeae 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.
FEBRUARY 2016
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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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Management of Debiopharm Group
ROLLAND-YVES MAUVERNAY
President and Founder,
Debiopharm Group™
16
THIERRY MAUVERNAY
Delegate of the Board,
Debiopharm Group™
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
COMPANY PROFILE
APRIL 2015
Marketed Products
WHAT WE DO: CRITICAL ACHIEVEMENTS
19
ELOXATIN®, ELPLAT®, DACOTIN®, DACPLAT® (OXALIPLATIN)
20
DECAPEPTYL®, TRELSTAR®, PAMORELIN®, NEO DECAPEPTYL® (TRIPTORELIN)
21
SALVACYL®, MOAPAR® (TRIPTORELIN)
22
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
What we do: Critical Achievements
2
Compounds
Oxaliplatin
Triptorelin
5
Successful
marketed
products
Eloxatin®:
Gold standard &
blockbuster
Decapeptyl® :
3 sustained-release
formulations
(1, 3, 6 months)
Salvacyl®
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
ELOXATIN®, ELPLAT®, DACOTIN®, DACPLAT® (OXALIPLATIN)
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 oxaliplatin 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.
IN SHORT
Triptorelin was discovered by Professor Andrew Schally, who received the
Nobel Prize in 1977 for his discovery.
x2
It is a worldwide gold standard
treatment in metastatic colorectal
cancer.
ACHIEVEMENTS
1996 First approval of the lyophilised formulation obtained in Europein 1996
within seven years of in-licensing
2006 Approval of the aqueous formulation
in 2004 in France, in 2005-2006 in
most other European countries
2002 Record 46-day Food and Drug Administration (FDA) approval in 2002 in
the United States
2009 Approval of the aqueous formulation
in Japan in 2009
2015 Gastric cancer approval in Japan in
2015
2005 Approval in Japan in 2005 (Elplat®)
Approval of the aqueous formulation
in 2005 in the US
DEBIOPHARM VALUE ADDED
Identification of the first clinical indication (mCRC)
Optimization of the efficacy-safety profile
Clinical development leading to the first file submission registration in France
19
DEBIOPHARM GROUP - COMPANY PROFILE CMC Continuous life cycle management (ie: solution formulation)
15 patent families covering process, combination,
formulation and use
FEBRUARY 2016
DECAPEPTYL®, TRELSTAR®, PAMORELIN®, NEO DECAPEPTYL® (TRIPTORELIN)
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.
IN SHORT
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.
ACHIEVEMENTS
1986 1986 European approval was obtained in
1986 within 4 years of in-licensing.
Three formulations available, which
provides several options to the health
practitioners.
DEBIOPHARM VALUE ADDED
Development and registration of the triptorelin
1-, 3- and 6-month sustained release formulations in Europe, in North America and the rest of
the world.
First worldwide registered sustained release
formulation of a gonadotropin releasing hormone
(GnRH) agonist in 1986.
Continuous life cycle management (new formulations, route of administration, indications).
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
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, Denmark, 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 21
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
COMPANY PROFILE
APRIL 2015
Debiopharm International SA
INTRODUCTION24
MANAGEMENT25
22
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Debiopharm International SA
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 worldwide.
ESPACE ‘APRÈS-DEMAIN’ - EPFL
Debiopharm 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 Products
•
•
Preliminary DMPK characterization (ADME and bioanalytics)
23
Applied Bioresearch supporting biomarker and drug activity assessment
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Management of Debiopharm International SA
BERTRAND DUCREY
Chief Executive Officer,
Debiopharm International S.A.
TOM GIBBS
Vice President ad interim,
Business Development & Licensing,
Debiopharm International S.A.
Director,
Debiopharm Diagnostics S.A.
NIGEL MCCRACKEN
Vice President,
Translational Medicine & Vice-President ad interim,
Clinical Research & Development,
Debiopharm International S.A.
CHRISTINE DEUSCHEL
MANUELA PERRAUDIN
PEGGY LIPP
Vice President,
Portfolio & Project Management,
Debiopharm International S.A.
Director,
Human Resources,
Debiopharm International S.A.
Director, Regulatory Affairs,
Business Intelligence &
Market Access,
Debiopharm International S.A.
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
MANAGEMENT OF DEBIOPHARM INTERNATIONAL SA
VANESSA CURRAT
HOUSSAM IBRAHIM
ALEXANDRE MARET
Director,
Legal Affairs,
Debiopharm International S.A
Vice President,
Pharmaceutical Development,
Debiopharm International S.A.
Director Finance and
Administration,
Debiopharm International S.A.
DANIEL BRANDT
Director Quality Assurance,
Documentation & Regulatory
Affairs,
Debiopharm International S.A.
25
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
COMPANY PROFILE
APRIL 2015
Debiopharm Research
& Manufacturing SA
INTRODUCTION28
OUR FUTURA PROJECT
29
SCIENCE & TECHNOLOGY
30
MANAGEMENT31
26
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Debiopharm Research & Manufacturing SA
Debiopharm Research & Manufacturing SA is a pharmaceutical research, development and production facility, 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)
OUR VISION & GOALS
Competencies in R&D and production of poorly
soluble pharmaceutical API
Expertise in sustained release formulations
•
•
•
Infrastructure
5 buildings
Our central location in Europe
Low human resources turnover
1000m2 cleanroom
20’000m2 available land
OUR MISSION
•
Development & manufacturing of
innovative pharmaceutical products
•
•
Use of cutting-edge technologies
27
Environmental-friendly manufacturing
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Our Futura Project
Debiopharm has announced its decision to diversify and expand its Swiss production facility, by acquiring industrial high value added activities in the pharmaceutical, diagnostic or medtech fields. Debiopharm has over 35
years of expertise in R&D and GMP-compliant manufacturing of complex pharmaceutical products. Together with
a logistic platform for worldwide delivery, established quality assurance and regulatory certification, Debiopharm
is the ideal partner to optimize, scale-up and manufacture innovative products.
OUR MISSION
Expand and diversify pharmaceutical industrial operations
in Debiopharm Research & Manufacturing (DPRM).
OUR GOAL
Acquire a company or in-license one or more industrial
opportunities for optimization and production in DPRM
for commercialization by 2018.
WE LOOK FOR
• Hard-to-make drugs
• Highly complex formulated drugs
• Polymeric devices
• Biologics niche products
• Premium diagnostics
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DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
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 reconstitution 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.
29
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Management of Debiopharm Research & Manufacturing SA
CÉDRIC SAGER
MARIE-ANNE BARDET
YVES GALY
PATRICK GARROUSTE
Chief Executive Officer,
Debiopharm Research &
Manufacturing S.A.
Logistics & Strategic Planning
Director,
Debiopharm Research &
Manufacturing S.A.
30
Project Management
& Scientific Director,
Debiopharm Research &
Manufacturing S.A.
Pharmaceutical Development
Director,
Debiopharm Research &
Manufacturing S.A.
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
ANNE MARGUERETTAZ
Regulatory, Optimization and
Industrialization Director,
Debiopharm Research &
Manufacturing S.A.
VINCENT GRIFFOUL
Technical Services
& Process Improvement Director,
Debiopharm Research &
Manufacturing S.A.
MANAGEMENT OF DEBIOPHARM RESEARCH & MANUFACTURING SA
OLIVIER IMBODEN
THANH LIEM VU
MARCO SALVAGNI
Administration & HR Director,
Debiopharm Research &
Manufacturing S.A.
Quality Assurance Director,
Debiopharm Research &
Manufacturing S.A.
Director of Operations,
Debiopharm Research &
Manufacturing S.A.
31
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
COMPANY PROFILE
APRIL 2015
Debiopharm Investment SA
INTRODUCTION34
EXISTING COMPANIES PORFOLIO
34
MANAGEMENT36
32
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Debiopharm Investment SA
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.
FINANCIAL DEPARTMENT
REAL ESTATE DEPARTMENT
PRIVATE EQUITY
•
•
•
•
Investment Diversification
•
Cash management
Currency hedging
Global balanced portfolio
management
Risk management
•
Investing in residential and/
or commercial real estates,
property and facility management.
Dedicated to buy, build and
develop new estates in harmony with our values
•
Equity investment in small
and medium companies
•
Commitment in Funds
EXISTING COMPANIES PORFOLIO
COMPANY
DESCRIPTION
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.
33
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
COMPANY
DESCRIPTION
CoorpAcademy develops and produces MOOCs (Massive Open Online
Courses) solutions for corporate clients.
aloe energy
Aloe Energy is one of the Top 5 solar operators in France with installed
capacities 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.
KeyLemon
Advanced online authentication solution based on face recognition.
Offer its clients access to the highest number of resorts with a single card.
34
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Management of Debiopharm Investment SA
VALÉRIE CALVAYRAC
CEO, Debiopharm Investment S.A.
SAMUEL MOULIN
Chief Investment Officer,
Financial department,
Debiopharm Investment S.A.
ALEXANDRA LE COZ SANCHEZ
Director,
Private Equity Department,
Debiopharm Investment S.A.
35
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
SOPHIE GENECAND
Director,
Real Estate Department,
Debiopharm Investment S.A.
COMPANY PROFILE
APRIL 2015
Debiopharm Diagnostics SA
INTRODUCTION38
PORTFOLIO38
MANAGEMENT39
36
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Debiopharm Diagnostics SA
Diagnostics are an important part of Debiopharm ’s development strategy. Why?
Because diagnostics are the foundations of the future of medicine and bring us:
•
•
•
•
Patient stratification for better health outcomes
Cost savings for the payer
Quicker development process and
Improved success rate
OUR MISSION
OUR VISION & GOALS
Investment in innovative diagnostic
companies to:
•
Provide an essential part of the patient
treatment path
•
•
•
Complement in-house diagnostic activities
Consolidate current investment portfolio
Make new investments in companies
developing platforms and content (tests)
Develop projects in diagnostics
Give insight into cutting edge diagnostics
Facilitate access to new technologies
DEBIOPHARM DIAGNOSTICS’ PORTFOLIO
COMPANY
DESCRIPTION
STAGE
Signatures to guide cancer treatment.
Prognostic tests for cancer severity and
recurrence
On the market since 2004 (Europe)
and 2008 (USA)
Point of care turn-key Dx platforms.
Instruments and cartridges for simple
and rapid molecular diagnostics
37
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Idylla platform and first test
launched in September 2014
COMPANY
DESCRIPTION
STAGE
Blood-based Colorectal Cancer
screening
Signature for colorectal cancer used to
determine the need for coloscopy
Market entry through
collaboration in 2014
Life science platform. It helps translate
breakthrough science into drugs by
providing an incubator and resources for
young biotechs
38
Immunomodulation in autoimmunity
and transplantation
Preclinical
Potential life-saving detection of
sepsis
Host response signature for early
identification of sepsis
Development Phase
Focused on active immunotherapy for
autoimmune and inflammatory
diseases
Initial public offering (IPO) in 2010
Current vaccine development
efforts are in Crohn’s disease,
rheumatoid arthritis and lupus. In
Phase IIb/III
New solutions for MDx pretreatment
Sample preparation technologies for
molecular diagnostics
Development phase
Company that develops cost-effective
and rapid molecular devices to detect
genes at Point-of-Care
Market entry in 2016
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016
Management of Debiopharm Diagnostics SA
ROLLAND-YVES MAUVERNAY
President and Founder,
Debiopharm Group™
THIERRY MAUVERNAY
Delegate of the Board,
Debiopharm Group™
TOM GIBBS
Director
Debiopharm Diagnostics S.A.
Vice President ad interim,
Business Development & Licensing,
Debiopharm International S.A
39
DEBIOPHARM GROUP - COMPANY PROFILE FEBRUARY 2016