Transcript Mahinda-Marketing.pps

Novel Drug Marketing
• Group 2
• Mahinda C. Edirisooriya
Content
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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
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Thailand
New case 10,000 / year
1993 – 2003
Increased
from 9.0 to 19.8 / 100,000
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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?
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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
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“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
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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