hale & tempest how to provide affordable medicines in today’s competitive global market dr....
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Hale & Tempest
How to provide affordable medicines in today’s competitive
Global MarketDr. Brian W Tempest
www.briantempest.com
World Generic Medicines Congress
London, UK
27 February 2013
Hale & Tempest
Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia
and India where he has lived for the last decade.Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until 2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director
Far East and Regional Director Middle East & Africa from 1985 to 1992.Brian has worked in the Pharmaceutical Industry for the last 41 years and has managed Healthcare
businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan and India. He has also led many sessions at Investor Meetings held around the world.
He is now Independent Chairman of Religare Capital Markets, a Non Executive Director of Fortis Healthcare the leading Asian Healthcare Company, a Non Executive Director of SRL the largest Indian Diagnostic Company and a Non Executive Director of Glenmark Pharmaceuticals. He is a member of the SCRIP Global awards panel and is on the Editorial Board of the Journal of Generic Medicines. Brian speaks at global conferences and more information on these presentations can be
found on his website www.briantempest.com.Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became Chairman of the Advisory Board for the Lancaster University Management School, UK. He is a
Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is now Chairman and Senior Partner of Hale & Tempest Co Ltd
Hale & Tempest
A Slide from a UK Headhunter
Hale & Tempest
The Biggest Healthcare Fraud in HistorySource: Daily Mail 3 July 2012
Hale & Tempest
A Pfizer Decade of Bribery source: FT August 7 2012
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Big Pharma Business Model Broken source: Pharmatimes World News April 2012
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Pharma in Crisis Source: Pharmatimes February 2013
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The Strategic Changes by Big PharmaSource: FT December 5 2012, Franz Humer, Roche Chairman
•Possible to cut 30-50% off development costs via CT efficiencies
•Shift from product focus to patient focus using diagnostic tools
• In Europe there isn’t one Government or politician interested in the health of the Industry
•USA & Latin American countries open to rewarding innovation
•Industry has to change fundamentally how it manages costs
•Leaner headquarters & smaller central functions •Division of the industry into 2 parts
• A Innovative businesses able to charge a premium price
• B Large scale manufacturers who can compete on cost
Hale & Tempest
Pfizer ROI of R&D Expenses
“Nobody endured these lessons harder than Pfizer. The company built the world’s largest pharmaceutical research centre in Connecticut, USA , a 160 acre site with more than 5,000 employees at its peak and 2.7m sq ft of research space. But the only major drug to come out of the sprawling facility in the past 20 years was the smoking cessation treatment Chantix” Source; Pharmatimes February 2012
Hale & Tempest
Will Big Pharma Change?
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Or be like Popeye the sailor man
“I Yam what I Yam what I Yam”
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Global Brands Vs. Generics 2011-16 Source: IMS
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Asian Growth – even Myanmar source: Bangkok Post 26 July 2012
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USA Life Expectancy & Pharma Costs Source: US Health in International Perspective Jan 2013
Hale & Tempest
Generics - Rising Risk & Competition
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Patent Expiries to 2018 source: EvaluatePharma 2012
Hale & Tempest
Products Going Off Patent in 2015 $33bSource: Evaluate Pharma 14 February 2013
Hale & Tempest
The Teva Future – Standing Still Source: RBC Capital 12 December 2012
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Teva Losing Control of Costs in the EU source: Teva June 2012
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Reference Pricing Globally Endemic
Source : Istanbul September 2012
Pharma purchases reduced from 1.7% of GDP to 1.0% of GDP in Turkey
Russia, South Korea & Saudi Arabia health ministries now requesting Turkish prices
Everybody is referencing everybody else on Pharma prices in Europe
Bulgaria is currently referencing prices in 17 other countries
Hale & Tempest
Rising Price Competition from Pharma at Jan 2012
ATORVASTATIN
- Ranbaxy in India 5 Rs per tablet
- Pfizer in NZ 1 Rs per tablet
CEPHALEXIN
- Ranbaxy in India
- GSK in India half price
Hale & Tempest
BiosimiIar Challenges 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
Hale & Tempest
Sandoz Biosimilars –18 years ROI source: Pharmacloud June 2012
Hale & Tempest
Biosimilar Deals – to share the risk
Cipla & Biomab, China $165m 12 products Richter & Stada – mABs Celltrion, Korea -Hospira, Egis, Hikma, BB, etc Biocon & Mylan, USA, mABs: Xbiotech Teva & Lonza, EU – limited range Biocon Idec & Samsung, Japan – now Merck Watson & Amgen, USA Fuji Film & Kyowa Hakko Kirin DRL & Merck-Serono, Germany - mABs Actavis & Bioton, Poland - closed Pfizer & Hisun, China - expanding
Hale & Tempest
New Biosimilar Company (with Merck)
Hale & Tempest
Indian Generic Cos continue to growSource: Pharmatimes World News Feb 5 2013
•Many Indian Companies in 2013 showing a sales growth of >20%
•Indian Pharma Exports 2008-2012 have shown a %CGR of +19% in sales
• New Product Pipeline in USA ANDAs shows approvals from India in 2012 was 37% with 178 out of a total of 476 and in 2011 33% with 144 out of 431
•New ANDA filings of ANDAs in the USA from India indicate 51% in 2011 and 49% in 2010
Hale & Tempest
DRL 2011/12 Sales – CIS > India Source: OTC Bulletin 31 May 2012
Hale & Tempest
NIBS (tyrosine kinase inhibitors)Will these challenge 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
Tofactinib, Pfizer, RA
Hale & Tempest
China: Hisun-Pfizer filing 2013/4 in West source: Fierce Pharma
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Global Distribution - Walgreens, Boots, Nanjing Axis - with Almus Brand
Source: FT Sep 16 2012
Hale & Tempest
However forecasting can be difficult2012 Nobel Laureate in Medicine - Biology School Report
source: Daily Telegraph October 9 2012
