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Dr Sohail Manzoor Director Medical Regulatory Affairs Hilton Pharma

?In all affairs it is a healthy thing now and then to hang a question mark on the things you have long taken for granted." -Bertrand Russell. Pakistan . 664 Pharma Companies634 National companies30 MNC's212 national Pharma companies are represented by the P

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Dr Sohail Manzoor Director Medical Regulatory Affairs Hilton Pharma

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    1. Dr Sohail Manzoor Director Medical & Regulatory Affairs Hilton Pharma Strategic Implications of Clinical Research for Generic Companies

    2. “In all affairs it is a healthy thing now and then to hang a question mark on the things you have long taken for granted.” -Bertrand Russell

    3. Pakistan 664 Pharma Companies 634 National companies 30 MNC’s 212 national Pharma companies are represented by the Pakistan Pharmaceutical manufacturers Association (PPMA). 400 Pharmaceutical Manufacturing plants 370 national Pharma Companies 30 MNC’s

    4. 86 Billion PKR Market

    5. 86 Billion PKR Market

    6. Market Share MNC’s vs National

    7. Pakistan Per Capita drug spending is 8 US $ (488 PKR). Pakistan’s population is 2.4 % of world’s Population Share of the Global Pharmaceutical market is 0.31 % 40,000 brand names are registered comprising of 1,400 molecules. 28 : 1 Diclofenac sodium 98 Brands Omerprazole capsule 86 Brands Ciprofloxacin tablet 84 Brands

    9. Generic Market (Gx) A REALITY   The quality of generics manufacturers’ production has improved dramatically, and these companies are far larger more sophisticated The rise in health-care costs means that even in developed markets, generic drugs will become increasingly popular and that in emerging markets they will be a key to gaining a broader presence. Finally Rx companies are facing a well-known shortfall in innovation as Gx companies are beginning to expand into innovative activities cost-effectively.

    10. Generic Market (Gx) ---- A REALITY Of the 3.5 billion prescriptions written in the U.S. in 2004 56% were for generic drugs – a fourfold increase in last 20 years . Worldwide, $45.2 billion of generic drugs were sold in 2004.

    11. Why The Need According to the WHO 14 million people die each year from communicable diseases Malaria TB Sleeping sickness kala azar For which treatment options are inadequate or do not exist, and for which R&D is insufficient

    12. Why the NEED About 97 % of deaths from communicable diseases occur in developing countries. Infectious and parasitic diseases account for 25 % of the disease burden in low- and middle-income countries compared to only 3 % in high-income countries. Eliminating communicable diseases would close the mortality gap between the richest 20 % of the world population and the poorest 20 % ( World Bank report)

    13. Market Failures Over the last few decades major progress in molecular biology and biotechnology has enabled the development of increasingly sophisticated medicines to cure a wide variety of diseases. Meanwhile, global expenditures on health R&D has increased dramatically, R&D funds are focused on diseases of the rich. Only 10 % of global health research is devoted to conditions that account for 90 % of the global disease burden -- an imbalance that has been referred to as the 10/90 disequilibrium.

    14. 80/20 People in developing countries, who make up about 80 % of the world Population, only represent about 20 % of worldwide medicine sales. All of sub-Saharan Africa totals less than 2 percent of the global pharmaceutical market.

    15. Possible Issues !! Current reality is majority of registration trials are focused on the United States and Europe. Pattern of disease in our population is different from that of the US / European population !! Disease characteristics in Asian patients may be different from those seen in white patients!! This is particularly evident in breast cancer. In Singapore Women Peak incidence of breast cancer in their 40s In United States, the peak incidence is in women in their 60s. Postmenopausal patients in Singapore 47% Postmenopausal patients in USA 80% Less hormone-receptor-positive tumors in Asian women

    16. Different Pharmakokinetics !!!! How the body handles drugs may be different in Asian patients compared with white patients !!! different metabolic rates and genetic variations The acetylation of drugs 80% of Asians are Fast acetylators 60% of Whites are Slow acetylators. Body size difference Difference in diet/alcohol –P450 Enzymes

    17. Dose Difference !!!??? This study demonstrated interethnic differences in myelotoxicity with doxorubicin and cyclophosphamide in breast cancer patients. Higher portion of Singaporean patients 55% experienced severe myelotoxicity vs. 20 % Australian patients. Beith JM, Goh BC, Yeo W, et al. Inter-ethnic differences in the myelotoxicity of adriamycin/cylophosphamide (AC) for adjuvant breast cancer.of the American Society of Clinical Oncology 38th Annual Meeting, May 18-21, 2002; Orlando, Florida.

    18. Local Normal Ranges !!! Do we know what is the average HB or normal range of HB is among our population. We follow 12-15 Mg HB range of western female population Where they have a birth rate ranging from –0 to 2 per women as compared 5.4 births per women in our country !!! Can the HB range be SAME !!!!! ?????

    19. Regulatory Requirement Now Our regulatory authorities have advised for all new product registrations--- to submit Post Marketing Surveillance (PMS) report.

    20. Export Potential Central Asian states, Africa and middle east has number of requirements for registration eg PSUR, Bioeqvilance & PMS. Pakistan Medicine exports are about 60 million US $ India Medicine Exports are 570 Million US$ Clinical Trials with Generic products will make registration FASTER in export market.

    21. HCV -Pakistan Approx.10 million HCV patients Treated with Interferon Alfa TIW with Ribavirin for six months. Interferon alfa half life of 6 hours– given TIW with weekend OFF---- Effective Drug levels not MAINTAINED to supress HCV virus. Peg interferon once a week maintains DRUG LEVEL through out the week. Cost difference 312000 PKR vs 60000 PKR ( 5 : 1) A study with DAILY DOSE of standard interferon showed a better response of 94% as compared to 78 % with Peg interferon.

    22. Clinical studies Benefits !! Usually Peg interferon alfa 2 a180 microgram is used--- some Gastroentrologists suggest its 90 Microgram also gives SAME result with Half the cost. Daily Dose standard Interferon study for Our HCV patients -- if positive – can save money and along with giving a better result for our patients.

    23. Clinical trials Phase 4 studies with a generic molecule will help to DIFFERENTIATE , More EVIDENCE BASED Proof of QUALITY & EFFICACY confidence to the prescriber. A Generic drug with ITS OWN clinical data will be EASY to Sell.

    24. Need Now most doctors ask for LOCAL data Now more doctors WANT to do Clinical studies. Now More National companies have MEDICAL departments

    25. Business & Science Actually Business RULES the Science in reality. But GOOD Strategic science if thought & implemented properly can make the Business to INVEST in science to get more business. National Companies should INVEST more in local studies to Find answers for better logical,quality and economical treatment---all this will definitely Increase Business---due to Local evidence based science

    26. Clinical studies Clinical studies will find out about Hb ranges Dose requirements Side effects profiles Based on such information NATIONAL TREATMENT GUIDELINES for various diseases can be made– for better patient care. This can be the most Ethical WINNING Medical Marketing tool for the national Pharma companies.

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