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Novel Drug Marketing • Group 2 • Mahinda C. Edirisooriya 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 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 Distribution of Hepatocellular carcinoma in the world Country New case/Y Death/Y USA 15,000 13,000 Europe 53,600 57,000 557,000 530,000 Rest of the world http://thestar.commy/health/story.asp?file=/2006/6/25/health.14627480&sec... 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 Combination of risk factors for HCC Normal epithelial cell Hepatitis B &C Chronic hepatitis and/or cirrhosis Change hepatocytes Aflatoxin & Alcohol Dysplastic hepatocytes HCC History of pharmacology and Toxicology J. Essigmann Development of novel drug Why “Modified Megestrol” Best? • • • • 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 Life cycle of the drug Profit Risk Patent lifetime Investment 0 5 10 15 20 25 30Years after discovery History of pharmacology and Toxicology J. Essigmann Drug regulation in Thailand My. Of health Thai Food and drug Administration (FDA) Legal basis Drug license •Manufacturing •Sell (wholesale, retail) •Importation Drug Act. of B.E. 2510(1967) 4th Amendment 2530 (1987) Product •Registration •Assessment •Quality control Pre-marketing Inspection Control •Drug promotion •Advertising •Distribution channel •Quality monitoring •Good Manufacturing practices (GMP) Post-marketing Novel drug company • Target area – Thailand • Investment Capital Product Market Premises Machinery Equipment Technology and knowledge Human resource Registration Clinical trials Safety monitoring Distribution Brand building Field forces Information Technology Market Distribution channel Manufacturer Agent/distributor Own distributor 6% 2% wholesalers 7% 4% Health centers Private clinic 8% Governmental Pharmaceutical organization 27% 58% Retail drugstores 30% Consumers 2% General and specialized hospital 60% Production and Revenue • • • • • Market cont. 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 For two month treatment (per person) 1 kg “Modified Megestrol” Annual production 96kg worth = 4$ = 240$ = 4/160 x 106 $ = 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 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 Market cont… • 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… Monitoring and feed back • Hospital records • Health care professionals • Pharmacist • Drugstores • Patients • Sales information 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 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 vitro in-vivo and in 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