Hale & Tempest How to provide affordable medicines in today’s competitive Global Market Dr. Brian W Tempest 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 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 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 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 History Source: Daily Mail 3 July 2012

Hale & Tempest A Pfizer Decade of Bribery source: FT August

Hale & Tempest Big Pharma Business Model Broken source: Pharmatimes World News April 2012

Hale & Tempest Pharma in Crisis Source: Pharmatimes February 2013

Hale & Tempest The Strategic Changes by Big Pharma Source: FT December , 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?

Hale & Tempest Or be like Popeye the sailor man “I Yam what I Yam what I Yam”

Hale & Tempest Global Brands Vs. Generics Source: IMS

Hale & Tempest Asian Growth – even Myanmar source: Bangkok Post 26 July 2012

Hale & Tempest USA Life Expectancy & Pharma Costs Source: US Health in International Perspective Jan 2013

Hale & Tempest Generics - Rising Risk & Competition

Hale & Tempest Patent Expiries to 2018 source: EvaluatePharma 2012

Hale & Tempest Products Going Off Patent in 2015 $33b Source: Evaluate Pharma 14 February 2013

Hale & Tempest The Teva Future – Standing Still Source: RBC Capital 12 December 2012

Hale & Tempest Teva Losing Control of Costs in the EU source: Teva June 2012

Hale & Tempest 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 grow Source: Pharmatimes World News Feb Many Indian Companies in 2013 showing a sales growth of >20% Indian Pharma Exports 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 % 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

Hale & Tempest Global Distribution - Walgreens, Boots, Nanjing Axis - with Almus Brand Source: FT Sep

Hale & Tempest However forecasting can be difficult 2012 Nobel Laureate in Medicine - Biology School Report source: Daily Telegraph October

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