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Novel Drug Marketing

Explore the distribution and incidence of Hepatocellular Carcinoma globally, the development of a novel drug, drug regulation and distribution, investment trends, competition, and advertising strategies. Learn about the primary and secondary causes of HCC, risk factors, history of pharmacology and toxicology, and the market landscape in Thailand.

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Novel Drug Marketing

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  1. Novel Drug Marketing • Group 2 • Mahinda C. Edirisooriya

  2. Content • Hepatocelluar Carcinoma (HCC) • HCC distribution & Incidence • Development of novel drug • Novel drug company • Drug regulation and distribution • Investment, Annual estimation, Annual production, Distribution, Trend and Competition, Advertising, monitoring and feed back

  3. Hepatocellular Carcinoma (HCC) Primary cancer • Origin in the skin or in tissue that line or cover internal organ. • HCC origin from Hepatocytes Secondary cancer • Primary cancer metastasis to other organ or tissue and start cause cancer

  4. Distribution of Hepatocellular carcinoma in the world Country New case/Y Death/Y USA 15,000 13,000 Europe 53,600 57,000 Rest of the 557,000 530,000 world http://thestar.commy/health/story.asp?file=/2006/6/25/health.14627480&sec...

  5. Liver cancer incidence in Thailand • Thailand New case 10,000 / year 1993 – 2003 Increased from 9.0 to 19.8 / 100,000 • Sa Kaeo province 1993 – 2003 Mortality From 3.1 to 26.1 / 100,000 http://www.google.co.th/search?=en&q=aflatoxin+thiland&btnG=Search&meta=cr%3DcountryTH

  6. Combination of risk factors for HCC Normal epithelial cell Chronic hepatitis and/or cirrhosis Change hepatocytes Dysplastic hepatocytes HCC History of pharmacology and Toxicology J. Essigmann

  7. Megestrol Similar to female hormone progesterone Treating for breast cancer and endometrial cancer Inhibit gonadotropin production in pituitary result decrease estrogen secretion Inhibit cell growth “Modified megestrol” Consist of estrogen receptor binding ligand, Linker and Warhead Warhead bind to DNA and shield from DNA repair Transcriptional factor binding to ligand and disrupt transcription Leading to apoptosis Development of novel drugWhy “Modified Megestrol” Best?

  8. Life cycle of the drug Profit Risk Patent lifetime Investment Years after discovery 0 5 10 15 20 25 30 History of pharmacology and Toxicology J. Essigmann

  9. Drug regulation in Thailand Legal basis Drug license Control • Manufacturing • Sell (wholesale, retail) • Importation • Drug promotion • Advertising Product Inspection • Registration • Assessment • Quality control • Distribution channel • Quality monitoring • Good Manufacturing practices (GMP) Pre-marketing Post-marketing

  10. Novel drug company • Target area – Thailand • Investment

  11. Market Distribution channel 6% 2% 7% 4% 27% 58% Health centers Private clinic Retail drugstores General and specialized hospital 8% 30% 2% 60% Consumers

  12. Market cont. Production and Revenue • Annual production – Estimate Dosage 160 mg/day At least 2 month of continuous treatment For one person = 160x30x2 mg/y/person = 9.6 g/Y/person For 10,000 new patients in Thailand = 9.6x104 g/y • Estimate Annual Production of “Modified Megestrol” = 96 kg • Annual Revenue – Estimation One dose (160 mg) wholesale = 4 $ For two month treatment (per person) = 240$ 1 kg “Modified Megestrol” = 4/160 x 106 $ Annual production 96kg worth = 4/160 x 106 x 96 $ = 25 x 103 $ Annual revenue Estimate = 25 x103 x 960 $ = 2.4 $ million • In 2002 Total value of production and import amount of drug market in Thailand = US $ 1143.18 • Our annual contribution for total drug market in Thailand = 0. 2 % Par pharmaceutical, INC, Spring Valley, NY 10977

  13. Market cont… Trend and competition • Association of South-east Asia Nation (ASEAN) agreed to create free trade area which will increase competition • Tax barrier will be gone by 2010 • Strong manufacture from other South Asian countries will enter to the Thai market • Good post harvesting technology • Vaccination for the Hepatitis B virus • Government pharmaceutical organization

  14. Advertising – Approvals from the FDA Publications through Media, booklets, posters Promotion Awareness of novel drug Access to educational, explanatory, and patient friendly materials Market cont…

  15. Market cont… Monitoring and feed back • Hospital records • Health care professionals • Pharmacist • Drugstores • Patients • Sales information

  16. Summary • Drug treat HCC • High incidence of HCC in Southeast Asia due to dietary aflatoxin, hepatitis virus and cirrhosis • SEA is the best market for most effective novel drug to treat HCC • New Product successfully distribute to the market and sell under the provision of drug act. In Thailand

  17. Conclusion Synthesis of “Modified Megestrol” Drug can produce DNA adduct that specific interact with the vER and selectively kill liver cancer cell Mechanism testing Mechanism testing - Test assumption that drug can form DNA adduct. The drug can form DNA adduct that bind to the vER Preclinical study To test the anti cancer drug properties    in-vivo and in vitro Clinical trial We have done whereas have evidence that novel drug is good effective for the HCC Marketing New Product successfully distribute to the market and sell under the provision of drug act. In Thailand

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