The value chain of a specialty pharmaceutical company

March 17, 2010Dirk Pamperin

Synthon

Synthon at a Glance

• Building on a history of success in Generic Small Molecules– Facts & figures

• Shaping the future – A compelling strategy

• Climbing the Pharmaceutical Industry Ladder– Life cycle products– Biosimilars and New Biological Entities– Our Expertise

Past and future success

Synthon

Building on a history of success in Generic Small Molecules

Synthon

Building on a history of success Key milestones of Synthon’s journey to success

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

1991 Founded in The Netherlands1993 Introduction of first product: generic dobutamine

1994 Opening of R&D departments in Prague the Czech Republic

1997 Opening of office in North Carolina , USA

1998 Acquisition of DP production facility in Spain

1998 Opening of office in Australia

2000 Acquisition of DS production facility and offices in Blansko CZ

2001 Acquisition of DS production facility and offices in Argentina

2003 Introduction simavastatine

2006 Introduction tamsulosine

2007• Acquisition of

Labs Rider, Chile• New line of business:

biopharmaceuticals • Opening of new R&D and production

unit in Czech Republic• Opening of office in Russia • Acquisition of Nafar in Mexico

2009 - 2010

Synthon

Building on a history of success We are present in key markets worldwide

1

2

3

4

5

6

7

8

8

765432

1

9

• 1250 employees in 9 countries

• 330 employees in Nijmegen

Synthon

Building on a history of success

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 20090

25

50

75

100

125

150

175

200

225

In € million

Turnover

Synthon

Building on a history of successR&D expenditure has created a strong portfolio

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 -

10.0

20.0

30.0

40.0

50.0

60.0

R&D expenses

• Products on the market: 28

• Molecules in development: 54 (10 under registration)

• More than 130 patent families file (average 12.7 annually)

Synthon

Total %Generic

EU Market

Total %EU Market

Bicalutamide 31 15

Tamsulosine 78 56

Simvastatine 16 14

Zolpidem 28 20

Zopliclone 35 25

Clozapine 22 11

Building on a history of successOur portfolio continues to be well positioned in Europe

Synthon

Value ChainBuilding on a history of success

Synthon

portfolioselection

• Focus on specialty generics and biopharmaceuticals• Opportunity evaluation of 100% of marketed products• Strong market knowledge and business intelligence

Value ChainBuilding on a history of success

Synthon

research /development

portfolioselection

• From active pharmaceutical ingredient (API) to finished product• Own in house development of APIs• Expertise in a wide range of complex dosage forms• First to Market Strategy: Launch as soon as possible• Meeting the need of partners: Early entry and main launch waves

Value ChainBuilding on a history of success

Synthon

research /development

intellectualproperty

portfolioselection

Value Chain

• Map R&D path in IP landscape• Patent own developments• Develop and support IP launch strategy• Ensuring full exploration of IP possibilities

Value ChainBuilding on a history of success

Synthon

registration

research /development

intellectualproperty

portfolioselection

• Capable of running complex procedures

• 30+ countries, 30+ regulatory systems

• Worldwide expertise, except Japan

• 95% of our partners rely on our expertise

• Strong relationships with authorities• Number of Marketing authorizations:

– Synthon: 600+ in 25 countries– Partners: 2000+ in 30 countries

Value ChainBuilding on a history of success

Synthon

registration

research /development

intellectualproperty

productionportfolioselection

Value Chain

• Own production capabilities for API (Czech Republic, Argentina)• Production site for solid finished dosage (Spain)• Strong and long lasting partnerships with CMOs all over the world

Value ChainBuilding on a history of success

Synthon

registration

research /development

intellectualproperty

productionmarketing /

salesportfolioselection

• Our costumers are partners• We are in business with 90% of generic companies

Value ChainBuilding on a history of success

Synthon

Building on a history of successOur integrated model delivers for our customers

We support our customers with a strong comprehensive solution

Reliable integrated supply

World wide regulatory expertise

R&D excellence

IP expertise

Synthon Products

Synthon

A Compelling Strategy

Synthon

If you don’t go forwards, you go backwards

Synthon

A Compelling Strategy

Focus

on

ther

apeu

tic a

reas

Ma

rke

ting

and

Sal

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act

iviti

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in

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ma

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Climbing the pharmaceutical ladder

Three dimensions for future success

Synthon

A Compelling Strategy -Climbing the Pharmaceutical Ladder

Synthon

Climbing the Pharmaceutical LadderSynthon is founding its new technology platforms form generic small molecule business

NBE’s

Biosimilars - MoAbs

Life cycle products

Generic small molecules

Synthon

Life cycle products Benefit for Patient and health care professionalFocus on products in interesting therapeutic areas

Synthon

Biosimilars – New Biological EntitiesAntibody (glycoprotein) 200-500 times larger then Simvastatin

Synthon

Biosimilars – New Biological Entities

Target discovery and optimization

Pre-clinical development

Clinical development

Phase I

Clinical developmentPhase II a & b

Clinical development

Phase IIIRegistration

Discovery POC & Safety Dose finding Efficacy & side-effects

Similarity & Safety Equivalent efficacyEquivalent safety

Full NDA

Submission

New biopharmaceutical

Biosimilar

Repeat for every new indication

One study may be sufficient to obtain approval for all registered indications

Full development versus biosimilar

Synthon

Biosimilars

Single modified cell(best producing cell selected)

Cell banking(MCB, WCB)

Expansion Production (bioreactor)Optimized for highest production

Cell linedevelopment

USP

DSP

Separation (centrifuge / filter) Purification (chromatography)Highest purity, minimal losses

Transformation

+

Cells from WCB

Established Infrastructure in Nijmegen

Synthon

Our expertise

Synthon

Research and Development

• Research in Chemistry• Upscaling of synthetic routes

• Small, intermediate and large scale production under GMP

• Various technologies

• Up scaling and GMP production from small to large scale

• Team of experts specialized in preclinical development

• Experiences with more than 50 Phase I studies

• Large network of experts for numerous indication

• Strong operational clinical team

Chemical and Pharmaceutical Development

Pre-clinical development

Clinical development

Phase I

Clinical development

Phase II a & b, IIIRegistration

• Well established relation with US and EU authorities also for scientific advice

Our expertise

Synthon

Climbing the Pharmaceutical Ladder

• Synthon is an established pharmaceutical company

• Brought range of technologies available

• Strong teams in all phases of drug development

• Open for collaboration

NBE’s

Biosimilars - MoAbs

Life cycle products

Generic small molecules

Internal

External

Your idea might fit

Synthon

www.synthon.com

Synthon BVMicroweg 22

P.O. Box 7071

6503 GN Nijmegen

T (+31) 243 727 700

pr@synthon.nl

The Netherlands