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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
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