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Strategic Pharma Issues

Strategic Pharma Issues. Dr. Brian W Tempest www.briantempest.com brian.tempest@clara.co.uk Mumbai, India May 2013.

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Strategic Pharma Issues

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  1. Strategic Pharma Issues Dr. Brian W Tempest www.briantempest.com brian.tempest@clara.co.uk Mumbai, India May 2013

  2. 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, a Non Executive Director of SRL Diagnostics and a Non Executive Director of Glenmark Pharmaceuticals. He is also an adviser to MAPE in India and UNCTAD in Geneva. 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

  3. There are few certain things in our WorldSource: T Stevenson, Fidelity Worldwide Investment Director, S Telegraph April 21 2013 • Populations growth • Ageing • Expansion of the World’s Middle Classes • Increasing demand for healthcare is as close to given as investors can hope for

  4. Global HealthcareSource: Sunday Telegraph April 21 2013

  5. Asian Growthsource: Bangkok Post 26 July 2012

  6. A Slide from a UK Headhunter

  7. The Biggest Healthcare Fraud in History Source: Daily Mail 3 July 2012

  8. A Pfizer Decade of Briberysource: FT August 7 2012

  9. Big Pharma Business Model Brokensource: Pharmatimes World News April 2012

  10. Pharma in CrisisSource: Pharmatimes February 2013

  11. Global Brands Vs. Generics 2011-16Source: IMS

  12. USA Life Expectancy & Pharma CostsSource: US Health in International Perspective Jan 2013

  13. 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

  14. Will Big Pharma Change?

  15. Patent Expiries to 2018source: EvaluatePharma 2012

  16. Products Going Off Patent in 2015 $33bSource: Evaluate Pharma 14 February 2013

  17. The Teva Future – Standing StillSource: RBC Capital 12 December 2012

  18. Teva Losing Control of Costs in the EUsource: Teva June 2012

  19. Actavis Sales MomentumSource: RBC 12 March 2013

  20. Mylan Sales MomentumSource: RBC 12 March 2013

  21. 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

  22. 30 generic packs, >2 years treatment £69200 king size cigarettes £68Source: Generics Bulletin 15 Feb 2013

  23. Indian Generic Cos continue to growSource: Pharmatimes World News Feb 5 2013 • Many Indian Companies in 2013 showing a sales growth of >20%, often with a buoyant USA profile • 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

  24. Compulsory Licence - 97% price cut with a 6% royalty Source: Economic Times 5 March 2013

  25. India Patent dismissed for EvergreeningSource: Financial Express 2 April 2013

  26. Aggressive EU-India Bilateral FTASource: ET 27 March 2013

  27. India to extend Compulsory LicencesSource: Economic Times 5 March 2013

  28. More CLs on the way in IndiaSource: 29 March 2013

  29. 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

  30. 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

  31. New Generic Company- Samsung No1 maker of smart phones source: Fortune India Feb 2013

  32. New Biosimilar Company (with Merck)

  33. Sandoz Biosimilars – an 18 years ROIsource: Pharmacloud June 2012

  34. 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 • Tofactinib, Pfizer, RA

  35. Hisun-Pfizer 51%/49% Manufacturing at Zhejiang, R&D at Hangzhou, HQ at ShanghaiHisun already has 40 FDA approved APIs

  36. Walgreens, Boots, Amerisource, ChinaSource: FT March 19 2013 • A global wholesaler axis • Walgreens has 45% of Alliance Boots with the option to buy the rest in 2 years • Walgreens and Boots jointly buy 23% in Amerisource Bergen • Boots Alliance owns 12% of Nanjing which is the 5th largest wholesaler in China & 50% of Guangzhou Pharmaceuticals which is ranked 6th wholesaler • 21% of Cardinal sales were to Walgreens which will now switch to Amerisource Bergen

  37. However forecasting can be difficult2012 Nobel Laureate in Medicine - Biology School Report source: Daily Telegraph October 9 2012

  38. Thank You brian.tempest@clara.co.uk www.briantempest.com

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