Transcript Global Generics Marketplace Seminar

Generic Country Markets &
Biosimilars
Chesapeake
Dr. Brian W Tempest
www.briantempest.com
[email protected]
UK
March 2014
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7. Generic Country Markets
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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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8. Biosimilars
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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
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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?
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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
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economic data
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 Hale & Tempest
NIBS (tyrosine kinase inhibitors)
Will these small molecules replace mAbs?
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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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Thank You
[email protected]
www.briantempest.com
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