How to provide affordable
medicines in today’s competitive
Global Market
Dr. Brian W Tempest
www.briantempest.com
brian.tempest@clara.co.uk
World Generic Medicines Congress
London, UK
27 February 2013
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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
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A Slide from a UK Headhunter
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The Biggest Healthcare Fraud in History
Source: Daily Mail 3 July 2012
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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 Pharma
Source: 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
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• B Large scale manufacturers who can compete on cost
Pfizer ROI of R&D Expenses
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“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
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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
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Generics - Rising Risk & Competition
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Patent Expiries to 2018
source: EvaluatePharma 2012
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Products Going Off Patent in 2015 $33b
Source: Evaluate Pharma 14 February 2013
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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
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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 now requesting Turkish prices
Everybody is referencing everybody else on
Pharma prices in Europe
Bulgaria is currently referencing prices in 17
other countries
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Rising Price Competition from Pharma
at Jan 2012
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ATORVASTATIN
- Ranbaxy in India 5 Rs per tablet
- Pfizer in NZ 1 Rs per tablet
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CEPHALEXIN
- Ranbaxy in India
- GSK in India half price
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BiosimiIar Challenges
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
Sandoz Biosimilars –18 years ROI
source: Pharmacloud June 2012
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Biosimilar Deals – 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 – 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
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Pfizer & Hisun, China - expanding
New Biosimilar Company (with Merck)
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Indian Generic Cos continue to grow
Source: 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
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DRL 2011/12 Sales – CIS > India
Source: OTC Bulletin 31 May 2012
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NIBS (tyrosine kinase inhibitors)
Will these challenge 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
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
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However forecasting can be difficult
2012 Nobel Laureate in Medicine - Biology School Report
source: Daily Telegraph October 9 2012
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Thank You
brian.tempest@clara.co.uk
www.briantempest.com
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