Frank PietersSVP, Global BioGenerics, Teva Pharmaceuticals

The Biosimilars OpportunityChallenges and key success factors

8 June 2010

2Biotechnology drugs sales increased 5 fold in last decade, expected to reach $100B this year

Global biotechnology drug sales in $ bn

3Biotechnology market is concentrated in the Western world, probably for reasons of access due to price

Geographical spread in Value Value Share of local prescription market

US

Europe

Japan

ROW

Biotechnology drug sales

Growth Opportunity?

USEurope

JapanROW

4Biotechnology drugs have solid efficacy, but access is limited � even in affluent countries

% of US patients treated 2008

Avastin Colorectal cancer 55-71% increase in progression-free survival 1

Avastin Breast cancer 52% reduced risk of progression 2

Herceptin Breast cancer (HER2+) 33-52% reduced risk of recurrence 3

Erbitux Colorectal cancer 47% increase in 7-year survival 5

Erbitux Head and neck cancer 70% increase in progression free survival

Humira Moderate/severe RA Double the ACR response rate 6

Enbrel Moderate/severe RA Double the ACR response rate 6

1 - first and second line metastatic patients 2- first line HER2- patients3 - HER2+ patients 4 - Diffused Large B-Cell Lymphoma patients5 � wild type KRAS patients 6 - ACR response criteria

Efficacy MeasureIndication

5Reason for lack of access: cost of treatment

Avastin Cancer Per course of treatment

Herceptin Cancer Per course of treatment

Lantus Diabetes Per year

Aranesp Anemia Per year

Rituxan NHL Per course of treatment

Humira RA Per year

Neulasta Neutropena Per course of treatment

Enbrel RA Per year

Remicade RA Per year

Epo Anemia Per year

Lipitor Cholesterol Per year Small molecule example

US Retail price, $

6

90% of biotechnology drugs will go off patent in next 10 years

93

17

45

24

86

All Biologics Patents expired 2009 or earlier

Patents expiring 2010-2015

Patents expiring 2016-2020

Biosimilar opportunity

Large opportunity

New affordable treatment options for more patients

Global biotech drug sales, $ bn, 2009

But this situation is changing

7What is specific about BioSimilars?

Definition A BioSimilar is a product that is physically, chemically, biologically, and clinically similar to an approved reference biological product

Development

Development of a BioSimilar requires:

� Establishing a manufacturing process that yields a product that is completely consistent with the physical, chemical, and biological specifications of the reference product

� Confirming similar efficacy and safety in preclinical / clinical studies

Approval

In the EU, Canada, and Japan:BioSimilars are approved following a BioSimilar regulatory pathway

In the US:A BioSimilar pathway is currently being established

8Many companies have expressed interest in BioSimilars

�AstraZeneca eyes move into BioSimilars�

�BioSimilars is a very reasonable thing for Lilly to do�

"Aims to launch 6 or more biotech generics from 2012 to 2017�

"Pfizer plans to market 10 to 15 BioSimilar drugs�

"BioSimilars are a major growth driver for Teva�

"Committed to broadening access to � biopharmaceuticals�

"Commitment to expand BioSimilar options to patients�

"BioSimilars would be one of Mylan�s growth opportunities�

"� has been investing in BioSimilars � and will continue to do so�

"Samsung Group set to enter BioSimilars market with $1.9 bn investment"

9The BioSimilars market has high barriers of entry

BioSimilars characteristics Minimum requirement to play

Capital-intensive manufacturing Access to manufacturing capacity

Up to $150m to develop a productUp to 8 years development cycle

Financial strength,long-term commitment

Highly complex manufacturingand development process Specialized know-how and expertise

10

Scale in branded and generics

Introducing Teva

Branded(Copaxone®,

and others)

Generics

14

31Revenues, $bn

16pro-forma with ratiopharm �acq. pending*

#11 Pharmaceutical company

#1 Generics player

35thousand

employees in 60 countries,covering 100 markets

$3bn Net income

* subject to regulatory approvals

11A decade of commitment to BioSimilars

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

First Teva BioSimilaractivities

First Teva BioSimilaractivities

SicorLithuaniaSicorLithuania

FDA approves Tev-Tropin

FDA approves Tev-Tropin

HualidaBiotechHualidaBiotech

CoGenesysCoGenesys EMA approves Tevagrastim

EMA approves Tevagrastim

SicorLithuania

ratiopharm �acq. pending*

IsraelBioSimilarR&D

Lonza JV

* subject to regulatory approvals

12A Global BioSimilars operation with strong internal development and manufacturing capabilities

Sicor Biotech (Lithuania):

Development / production of BioSimilarsin microbial systems(e.g. GCSF, Interferon)

Formulation development

13

Teva Israel Biotechnology R&D (Israel)

Development of BioSimilar MAb�s

A Global BioSimilars operation with strong internal R&D capabilities

14A Global BioSimilars operation with strong technology

Teva Biopharmaceuticals (USA)

Development of sustained-release proteins based on proprietary technology(Albumin Fusion)

15A Global BioSimilars operation with strong alliances

JV with Lonza (Switzerland)TL BiopharmaceuticalsAccess to the world�s largest commercial scale MAb manufacturing infrastructure

16A Global BioSimilars operation with strong M&A targeting

Ratiopharm (Germany):

Production of BioSimilars in mammalian systems (e.g. EPO, FSH) � acquisition pending subject to regulatory approvals

17Winning in BioSimilars requires a full set of skills

Time tomarket

Manufacturingcost

Customer value proposition

� Excellent Execution of CMC development� Accurate IP navigation� Clinical development in an evolving regulatory environment� Clinical trial placement and execution � Speed of action and sense of urgency

� High-yield cell lines� Solid production processes� Right Manufacturing scale

� Breadth of product portfolio� Focus on Affordability� Access to patients� Differentiation versus innovative providers

18BioSimilars at Teva

TevaBioSimilars

DevelopmentCulture

TevaBioSimilars

Manufacturing

TevaBioSimilars

Customer Value Proposition

� Fully integrated Development System� Innovative + Generic expertise and mindset� Generic IP navigation skills� �First to market� Culture

� In-house Quality Manufacturing� Broad CMO agreements� Lonza JV

� Teva Reputation� Focus on Affordability and Availability� Broad product portfolio => 1-Stop-Shop� Decentralization

19Reflections on Go-to-Market

Generic Innovativepromotional investmentpromotional investment

mar

ket s

hare

mar

ket s

hare

0%

100% high investmenthigh share

low investmentlow share

moderate investmentmoderate share

high investmentlow share

low investmenthigh share Analysis of the current

commercial results shows a very different range of achievements and market shares definitely linked to very different:

� development plans

� marketing investment

� commercial focus

The presence of several Outliers makes it difficult to see a clear trend

20

Teva has the proven ability to adapt “generic” and “branded” capabilities flexiblyto create a NEW winning Go-to-Market approach,

tailored to the specific product / environment

GENERIC MODELCOPAXONE MODEL

Branded GenericHybrid

A decision making tool,based on a product / environment matrix,

helps to decide which Go-to-Market approach to implement

NEW MODEL

Teva�s Go-to-Market Approach

21The Opportunity:Solid short term sales potential, broad and deep pipeline

Tev-Tropin®

Interferon α

TevaGrastim®

Neugranin®

Creating a 1-stop shop for BioSimilars

In the market

BLA filed / phase 3

Developing a broad and deep pipeline of

BioSimilars of the key proteins / MAb�sthat go off-patent in

the next decade

Eporatio

Neutroval�

Growth Hormone (U.S.)

GCSF (EU, ROW)

EPO (EU, ROW)

Interferon α (EU, ROW)

GCSF (US)

Long Acting GCSF (WW)

Rituximab (WW)TL-011

* Acquisition pending, subject to regulatory approvals

Teva ratiopharm*

�..

RatioGrastim

Thank you

Teva is ready for the BioSimilars challenge