Developments, Trends and Strategies
ANDREW BOURGOIN [email protected] NY Pharma Forum January 31st, 2012
Biologics Market: An Overview
Generics & API Intelligence at Thomson Reuters
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Agenda
Competition in Follow-on Biologic Development
Incentive and Challenges to Compete
Established Companies
Global Development
Strategies, Trends and Forecasts
Gaining a Competitive Advantage through M&A
Takeaways and Questions
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4
2011 T
hom
son R
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Competitive Landscape
Biologics: a $90bn Global Market
Class #Launched WW Sales
US$
No.
Blockbusters
%Blockbuster
Sales
rhProtein 65 $52bn 13 80%
MAb 26 $42bn 9 90%
Total 91 $94bn 22 85%
5 Source: IMS Health, Newport Premium for Generics, TR Research
Incentive To Compete In The Follow-on Biologic Market
6 Source: IMS Health, Newport Premium for Generics, TR Research
0
1
2
3
4
5
6
7
$B
US
WW
Global MAbs Market
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INN WW Sales
(US$B) Growth
Biosimilar Competition Not Expected Before
USA EU JPN Infliximab 6.3 10% 2010 2014 2012
Adalimumab 6.6 19% 2010 2018 2018 Bevacizumab 5.4 1% 2011 2014 2016
Rituximab 5.3 9% 2016 2013 2016 Trastuzumab 4.4 10% 2008 2014 2014 Ranibizumab 3.4 32% 2017 2014 2019 Cetuximab 1.5 5% 2015 2014 2016
Palivizumab 1.4 10% 2015 2014 2015 Natalizumab 9 16% 2014 2014 Omalizumab 8 16% 2007 2017
Panitumumab 4 81% 2017 2014 2018 Eculizumab 2 26% 2014 2017 2020
Source: IMS Health via Newport Premium for Generics, TR Research
First Wave FOB Launches
Therapy Brand Name Company Markets
Somatropin Omnitrope Sandoz EU, USA,
Canada, Japan
EPO Epokine CJ Corporation South Korea,
Thailand
EPO Binocrit Sandoz EU
EPO Retacrit Hospira EU
EPO Wepox, Epox Wockhardt India
EPO Epiao 3SBio China
EPO Erypo Biocon India
Filgrastim Nivestim Hospira EU, Austrailia
Filgrastim Ratiograstim Ratiopharm EU
INF A 2a Intefen 3SBio China
INF A 2b Realdiron Biotechna Ukraine
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Major Generic Companies Active in FOB Development
Company Proteins Antibodies Vaccines Launches
Teva FP UD FP EPO, GCSF
Sandoz FP UD EPO, HGH
Biocon FP UD FP GCSF
Hospira FP UD EPO, HGH
Zydus FP UD GCSF
STADA FP UD EPO
Actavis FP Via Bioton
Ranbaxy FP UD FP
Dr Reddys FP FP GCSF
Apotex FP UD FP
Cipla UD
9 Source: TR Research
Key: FP = Full Production, UD = Under Development
Big Pharma Committed To Compete
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Company Strategic Positioning (year)
Pfizer Announcement (10), Biocon
Merck Bioventures (09), Parexel, Hanwha (11)
Amgen Watson (11)
Biogen Idec Samsung (11)
Baxter Momenta (11)
Boehringer Ingelheim Announcement (11)
Many of the traditional innovator companies have the most to lose from competition in the follow-on biologics
market. Conversely, companies with established sales
and marketing forces in the US will have a competitive
advantage against competition void of such attributes.
-Thomson Reuters White Paper
Biosimilars and the Patient Protection and Affordable Care Act (H.R. 3590)
Section 351 of the Public Health Service Act (PHSA) amended to include an abbreviated biological license application (aBLA)
for highly similar biological products
Safety and efficacy
Large-scale clinical studies
Same condition(s)s of use, route(s) of administration, dose form, strength and utilizes the same mechanism(s) of action
as reference product
Interchangeability
Must produce the same clinical results as the reference product
Exclusivity
Continuing debate
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Biosimilars and the Patient Protection and Affordable Care Act (H.R. 3590) Continued
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Pre-Market Phase
Initial or annual biosimilar product development fee (BPD)
Reactivation Fee
Marketing Application Fee
Post-Market Phase
Establishment fee
Product Fee
Biosimilar User Fees Congressional Consideration
Many Similarities to the PDUFA Fee structure
Performance Goals
Initial Guidance? Waiting game
NEMJ article
Which Route to take? 351(a) v. 351(k)
Barriers To Entry Will Limit Competition
Biomanufacturing facility, additional capabilities
Significant clinical and non-clinical testing
Substantial, NDA-type dossiers
Post-market safety surveillance
Substantial manufacturing investments
Sales promotion and marketing
Intellectual property considerations
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Recombinant Protein Production: Emerging Markets
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0
2
4
6
8
10
12
14
16
18
20
India China ROW
Nu
mb
er
of
Co
mp
an
ies
Under Development
Full Production
MAb Production: Emerging Markets
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0
2
4
6
8
10
12
14
16
18
India China ROW
Nu
mb
er
of
Co
mp
an
ies
Under Development
Full Production
Companies Currently Manufacturing or Developing Active Substances For FOBs
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0
5
10
15
20
25
30
35
China India ROW EU
Inexperienced
Experienced
Biotech Capabilities Among The Top Chinese
Company Proteins Antibodies Vaccines Launches
Anhui Anke FP HGH, IFN
Amoytop FP GCSF, IFN, HGH
Beijing SL FP GCSF
Beijing Tiantan FP Hep B
Citic Pacific FP UD Etanercept
Chanchung Institute FP FP GCSF, IFN
Chengdu Hoist FP Radio MAb
Dalian Hissen FP Hep B, Rabies
National Serum FP Various
Shenzen Kexing FP IFN, HGH
Shenyang Sunshine FP EPO, IFN, IL2
Wuhan Institute FP FP MAb
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Key: FP = Full Production, UD = Under Development
Source: TR Research
Biologic Development in Japan and S Korea
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Company Proteins Antibodies Vaccines Launches
Aska UD
Celltrion FP UD Abatacept
CJ Cheil Jedang FP FP EPO
Dong-A Pharmaceuticals FP EPO, GCSF, INF,
HGH
Fuji UD
Gene Techno Science UD
ISU ABXIS UD FAb
Kissei FP GCSF
LG Life Sciences FP FP EPO
Mochida UD
Nippon Kayaku UD
Samsung UD
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2011 T
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Strategies, Trends and Forecasts
Number of Biologic Product Based Deals 2000-2011
20
0
50
100
150
200
250
First Wave Biosimilar Deals: EPO, G-CSF
Apotex & Cangene (1999), BioGeneriX (1999), Intas (2005)
Ratiopharm via BioGeneriX (2003)
Hospira via STADA (2006)
Barr via Pliva (2005)
Lupin via Bharat (2006)
Mayne via Pliva (2005)
Teva via Savient (1999), Sicor/UAB (1999), IVAX (2004), Tianjin Hualida (2006)
STADA via DSM Biologics (2001), Bioceuticals (2001)
Sandoz in-house
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Source: TR Research
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0
10
20
30
40
50
60
70
80
90
100
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Biologic Manufacturing, Supply & Distribution Deals, 2000-2011
2nd Wave Biosimilar Technology Acquisition
Mylan via Biocon (2009)
Hospira via BresaGen (2006), HGS (2008), Celltrion (2009), Pliva (2009)
Teva via CoGenesys (2008), Lonza (2009)
Pfizer via Biocon (2010)
Strides via Inbiopro (2010)
Kemwell joint venture with Boehringer Ingelheim (2010)
Gedeon Richter via Mochida (2010)
Cipla joint venture with BioMab (2010)
EGIS via Celltrion (2010)
Watson via Itero (2010)
Shenzhen Wanle via Celltrion (2010)
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Source: TR Research
The Trend Continues in 2011
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Merck via Parexel, Hanwha
Viropro via Spectrum
Samsung via Quintiles
Fujifulm via Merck Biomanufacturing Network
Lupin via Nueclone
Compass Biotechnologies via PanGen Biotech
Pharma Praxis and Brazils Ministry of Health
Mochida, Fuji
Natco via Mabxience
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Number of Biologic Product Based Deals 2000-2011
Biologics v Biosimilars
0
50
100
150
200
250
Biologics
Biosimilars
Teva: A Case Study
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Year Deal Activity Impact
2004 Purchased SICOR Biologics Facility
2005 Purchased Tianjin Hualida IFN Producer
2006 Collaboration with Protalix Novel Expression
2008 Purchased CoGenesys Albumin Infusion
2009 Alliance with Lonza Experience
Competitive Advantages Through Strategic Deals
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Current strategies for companies investing in follow-on biologic development focus on novel
technologies and manufacturing experience.
Improved efficacy and safety of products that employ these new technologies and
manufacturing practices will increase incentive for
innovative process development.
Strategic deals will focus on additional solutions that will provide a competitive advantage in the
follow-on biologic market in the U.S. and globally
Conclusions and Considerations
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A new paradigm in pharma competition
Global markets and regulations growing to meet domestic demand and international growth
Uncertainty remains and will effect decision makers but not development and less regulated
market launches
IP considerations and strategies will become defined.
CMR International, a Thomson Reuters business
Further information
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Andrew Fischer Bourgoin
Pharmaceutical Research Analyst
Thomson Reuters Healthcare & Science
White Paper on US Follow-on Biologic Competition
http://science.thomsonreuters.com/info/newport_whitepapers/
Thank You!