4th Indian Knowledge Millennium Summit

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Techdow The successful generic Enoxaparin
manufacturer

• 4th Indian Knowledge Millennium Summit
• By Shenzhen Techdow Pharmaceutical co.,
• Marketing department

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Outline

• 1. About Enoxaparin
• 2. Generic Enoxaparin
• 3. Generic Enoxaparin and Techdow

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Cardiovascular diseases!!
About Enoxaparin

• What are the most dangerous diseases for
  mankind?

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Worldwide death figure caused by CVD is
increasing
About Enoxaparin
SourceWorld Health Organization
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Worldwide CVD situationDeath due to CVD
as percentage of total annual deathUSA 40
Europe 42 China 40India 35Growth of
death rate due to CVD is growing much faster in
the developing countriesCVD is now more
prevalent in India and China than in all
economically developed countries in the world
combinedCVD occurrences rise 35 every year in
China60 of the worlds cardiac patients will
be Indian by 2010
About Enoxaparin
SourceWorld Health Organization
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About Enoxaparin
Worldwide continuous growth of spend on drugs for
CVD
Source IMS
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About Enoxaparin

• Enoxaparin An Effective Medicine
• General Information
• Market Analysis
• Major Indications
• Patent Situation

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General Information
About Enoxaparin

• Brand Name Lovenox/Clexane
• Low-molecular-weight heparin (LMWH) obtained by
  depolymerization of unfraction heparin
• Best selling anti-thrombotic drug and widest
  range of indications of LMWH in the world

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About Enoxaparin
Market Analysis
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Worldwide Sales Ranking of LMWHs
About Enoxaparin
PS Enoxaparin is sold as Lovenox in US and
France, and as Clexane in most other
countries.
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About Enoxaparin
Global Sales of Lovenox, 1999-2005
Source Datamonitor
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About Enoxaparin
Global Sales Forecast of Lovenox, 2006-2008
Source Datamonitor
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Major reasons for fast growing Enoxaparin market
About Enoxaparin

• Prolonged prevention/treatment period before and
  after surgery
• Regional immigration boosts the medical demand
• Increased indications in oncology are developing

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About Enoxaparin
Major Indications
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Indications Comparison of three LMWHs
About Enoxaparin
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About Enoxaparin
Major Indications of Enoxaparin

• Prevention of venous thrombosis formation and
  embolism formation in circulation in vitro
  during hemodialysis.
• Treatment of existing deep thrombosis, acute
  angina and non-Q-wave myocardial infarction.
• Treatment of acute coronary syndrome.

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About Enoxaparin
Patent Situation
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About Enoxaparin
Worldwide patent status of Enoxaparin

• Regarding basic patent EP0040144
• Expiry date in Germany May,
  2001
• Expiry date in France May, 2007
• Expiry date in Austria March,
  2006
• According to TRIPS Agreement
• No protection for the drugs
  launched before 1995 in developing countries.
• Administrative protection expired on
  June 30, 2005 in China.

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Generic Enoxaparin
Worldwide Situation

• Many international companies are interested in
  developing
• generic Enoxaparin
• Techdow developed successfully the generic
  Enoxaparin
• sodium

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Generic Enoxaparin and Techdow
1st company in China to produce generic
Enoxaparin approved by SFDA obtained cGMP
certificate Shenzhen Techdow
Pharmaceutical Co.,Ltd
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Generic Enoxaparin and Techdow
Company Profile

• Established in June 2004
• Located in Shenzhen Bio-incubator bldg.,high-tech
  park
• 290 employees

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Generic Enoxaparin and Techdow
First stage production facilities
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Generic Enoxaparin and Techdow
Blueprint of Techdows second stage production
site
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Generic Enoxaparin and Techdow

• Quality standard Full compliance with Ph.Eur
  current edition and USP proposed monograph
  (European Pharmacopoeia / US Pharmacopoeia)
• Manufacturing Manufacturing Enoxaparin API and
  five preparations with Registration License from
  SFDA (August 30, 2005).
• Productivity
• Annual output in the first stage 1 ton of API
  and 40 millions of pre-filled syringes.
• Annual output in the second stage 10 tons of
  API and the capacity of pre-filled syringes
  will be increased following the market demand

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Generic Enoxaparin and Techdow
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Generic Enoxaparin and Techdow
Preparations of Enoxaparin- ProlonginTM
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Generic Enoxaparin and Techdow
Advantages of Techdows Products

• Quality meets Ph.Eur. and is identical with the
  original
• No product-associated issues reported by Aventis
  during 2 years of sales
• Cost competitive solution
• Large scale production
• Broad customer network Brazil, Argentina,
  Uruguay , Columbia, Poland, Tunisia etc.
• Respecting international patent regulations
• Pre-filled syringe provides convenience of usage

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• Future direction in India
• Looking for the right cooperation partner to
  develop the Indian market
• Serve the health of Indian people
• Contribute to the exchange of technology and
  trade between India and China

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References

• Market Dynamics 2001 Anticoagulants, Lovenox,
  published by Datamonitor (31/12/2001)
• The cardiovascular outlook to 2007,published by
  Reuters and Aventis
• Aventis Annual Report 2002
• Drugs of Tomorrow 20 References 01anticoagulants
• Eric Racine. Differentiation of LMWH,
  Pharmacotherapy 200121(6Pt2)62S-70S
• Planes A et al, Thrombosis and haemostatis
  (1989) 60407-410
• GHAT Group, Archives of Orthopaedic and Trauma
  Surgery(1992)111110-120
• Mark Levine A comparison of low-molecular-weight
  heparin(enoxaparin sodium) and standard
  unfractionated heparin for haemodialysis
  anticoagulation. Nephrol Dial Transplant 1999
  14 2698-2703
• Planes A et al, Thrombosis and Haemostatis
  (1989) 60 407-410
• Antman EM,Cohen M,Radley D,et al. Assessment of
  the treatment effect of enoxaparin for unstable
  angina/non-Q-wave myocardial infarction. TMI
  11B-ESSENCE meta-analysis. Circulation 1999,
  1001602-1608

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THANK YOU