Chesapeake
Dr. Brian W Tempest www.briantempest.com
brian.tempest@clara.co.uk
UK
March 2014
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Europe source: EGA
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Reference Pricing Globally Endemic
Source : Istanbul September 2012
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Pharma purchases reduced from 1.7% of GDP to 1.0% of GDP in Turkey
Russia, South Korea & Saudi Arabia health ministries requested Turkish prices
Everybody is referencing everybody else on
Pharma prices in Europe
Bulgaria is referencing prices in 17 other countries
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Europe – generics take half the volume but a fraction of value sales
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EU Chemical Sales source: Chemistry World September 2013
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Open letter to Barroso from the Chairman of INEOS on 7 March 2014
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Generic Global Volume Share
Source: Sandoz
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30 generic packs, >2 years treatment £69
200 king size cigarettes £68
Source: Generics Bulletin 15 Feb 2013
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European Generic Prices
Source Ranbaxy
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Indian Pharma penetration of the UK source: FT January 13 2014
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Security of Power Supplies in Europe source: Economist 15 April 2014
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France Generic Market
Source: Generics Bulletin 15 February 2013
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US DMFs from India source: Citi Research 2013
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Number of USA Para IVs source: Generics Bulletin 14 September 2012, quarter indian
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USA Generic Market - Latest Challenges source: Jefferies 10 March 2014
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Africa Management source Ranbaxy
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Nigeria, South Africa & Angola source: Economist 12 April 2014
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African Factories
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Japan Generic Market source: Citi Research August 2013
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Japan Generic Opportunity
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Japanese Generic Market source: Mint 28 January 2014
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Brazil Generic Packs
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Brazil Top 10 Generic Cos
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Russia 2020 Strategy for Public Health
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Russian Market Evolution source: Frost & Sullivan 2011
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Vaccine Plant to take 1/3 Russian Market source: St Petersburg Times, 16 April 2014
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USA Generic Market - Latest Challenges source: Jefferies 10 March 2014
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Russia VLS List
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Russia 2020 Strategy
90% local manufacture of VLS list
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Russia 2020 Strategy
50% local manufacture of all products
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New Novartis Plant in St Petersburg source: Top Emerging Pharmaceutical Markets by Kathlyn Stone
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Russia & India – Big Picture source: ET March 26 2014
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Russia & India – Big Picture source: ET March 26 2014
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Indian Pharma in Russia - DRL source: website, 20 years
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Indian Pharma in Russia - Ranbaxy source: RUR, 20 years, 15% MS IMS May 2013, across 56 Regions
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Chinese Debt 200% of GDP in 2013 source: FT 2 April 2014
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Chinese NGOs source: Economist 12 April 2014
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China Pharma Industry Capex Plans
Source: Stravencom
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China Price Cuts source: Jefferies
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China API Exports decline by -9% source: Pharmatiimes February 21 2014
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Hisun Pfizer Pharmaceuticals Ltd source: Launch Announcement September 12 2013
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Hisun USA source: website
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Hisun USA acquires FDA approved DPI source: Press Release January 17 2012
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Hisun USA acquires FDA approved DPI source: Press Release January 17 2012
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China: Optimistic view of Domestic Market source: Jefferies 17 March 2014
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China Provincial Tenders source: Jefferies 17 March 2014
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Sino Biopharm strongest domestic pipeline source: Jefferies March 17 2014
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Zhejiang Huahai
(Novast also received an ANDA for an OC in 2010)
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China - Actavis Withdraws source: Bloomberg January 15 2014
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South Africa Generics
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Middle East & North Africa
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Jordan punches above its Weight
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Canada Generic Market
Source: Generics Bulletin 15 Feb2013
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Myanmar – a new market
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Which Way?
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Biologics & Small Molecules source: Kozlowski et al., N England J Med, 365:5, 2011
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Estimated 2016 sales of Top 20 products
Source: Cowen
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Biosimilar Share to 2018 source: EvaluatePharma 2012
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Monoclonal antibodies $m
Source: Synthon
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New Biosimilar Company (with Merck)
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Korean Pharma in Biosimilars source: Citi Research August 2013
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Biosimilars from China/India
Source: New York Times 20 Sep 2011
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Biotech Drugs where India has no DMF
Source: JGM Volume 6 p333 sep 2009
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Biosimilars from India
Source: Citi 25 September 2013
• Market opportunity of $1.5b to $2b for US & EU
• More clarity now on regulatory pathways
• OECD -$100m for R&D development of a MAB, $300m-
$400m to set up manufacturing capacity of 100,000L with annual R&D at $100m
• Developing Countries - $200m sales potential, $20m
R&D per year, manufacturing capacity of 1,000L planned
• India companies will enter emerging markets but use partnerships and alliances for OECD eg DRL
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• Developing Countries limited by affordability issues

Biosimilars Key Issue - Interchangeability source: GaBi Journal Biologics & Biosimilars 28 December 2013
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Biosimilar Market Sizes
Source: IMS, FT February 9 2014
• Global Biologics including Big Pharma blockbusters in
2012 is $170 b
• Biosimilars market size in 2012 is $2.5b and in 2020 is estimated at $25b
• VERSUS
• cost of manufacturing plant,
• cost of clinical trials,
• lower hospital tender prices,
• no interchangeability, cost of reps,
• patient-innovator relationship,
• competition from South Korea,
• authorised generics Hale & Tempest

First Herceptin Trastuzumab Biosimilar source: ET January 14 2014 Rs 40,000 per 440mg vial, Roche halved price at Rs 55,000
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Sandoz Biosimilars – an 12 years ROI source: Pharmacloud June 2012
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India Pharma in Biosimilars source: Citi Research August 2013
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BiosimiIar Challenges for CEOs
Do I enter or keep out?
Rituximab >100 patient CT for Roche, >600 patient CT for Generic companies
Interchangeability (AB rating) unlikely
Cabilly patents may delay US mAbs
EU mAb in 2013 from Hospira/Celltrion
EPO biosimilar side effects in Thailand
Many biosimilar manufacturers in China but few will reach EU/USA
Scientifically challenging - Amgen
Biobetters need a full dossier with health economic data
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Biosimilar Alliances – to share the risk
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Cipla & Biomab, China $165m 12 products
Richter & Stada – mABs
Celltrion, Korea -Hospira, Egis, Hikma, BB, etc
Biocon & Mylan, USA, mABs: Xbiotech
Teva & Lonza, EU – dissolved July 2013
Biocon Idec & Samsung, Japan – now Merck
Watson & Amgen, USA
Fuji Film & Kyowa Hakko Kirin
DRL & Merck-Serono, Germany – mABs
Bionovis (Brazil) & Merck Serono - 6
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NIBS (tyrosine kinase inhibitors)
Will these small molecules replace mAbs?
Axitinib, Pfizer, cancer
Cediranib, AZ, cancer
Pazopanib, GSK, cancer
Regorafenib, Bayer, cancer
Semaxanib, Sugen, cancer
Sorafenib, Bayer(Nexavar),cancer
Sunitinib, Pfizer, cancer
Toceranib, Pfizer, cancer
Vandetanib, AZ, cancer
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Tofactinib, Pfizer, RA

BTD : Breakthrough Therapy Designation source: Evaluate,FDA Jan 2014 31 products in 2013 6 ibs & 3 mabs J&J 4, GSK 3, Nov 3, smaller cos 12
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brian.tempest@clara.co.uk
www.briantempest.com
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