[e-drug] generic 3TC approved in Brazil

[e-drug@usa.healthnet.org]

E-DRUG: generic 3TC approved in Brazil
----------------------------------------------------
[Crossposted from Pharm-Policy with thanks.
http://www.ranbaxy.com/newsjul13_m.htm
E-drug does not publish commercial messages, but
the registration of an Indian generic in Brazil might
be an important milestone in the fight for access to
ARVs. NN]

ANTI-AIDS DRUG -LAMIVUDINE- GETS APPROVAL
FROM THE BRAZIL REGULATORY AUTHORITY

July 13, 2001, New Delhi

Ranbaxy S.P.Medicamentos ,Brazil, a majority owned company of Ranbaxy
Laboratories Limited, India, recieved approval from the Bazilian
Regulatory Authority, ANVS, for its anti-AIDS drug, Lamivudine . This is
the FIRST bio-equivalent generic approval in Brazil in the anti-AIDS
segment.

Lamivudine (3TC) is a synthetic nucleoside analogue with activity
against HIV-1. It is commonly prescribed as a part of HAART (High Active
Anti-Retroviral Regimen) in combination with other anti-retrovirals.
Lamivudine is a well tolerated NRTI ( Nucleoside analog reverse
Transcriptase Inhibitor) with no drug interactions and has proven
efficacy in combination with Zidovudine. It is the only retroviral to be
approved
for the treatment of Hepatitis B as well.

Ranbaxy expects to launch the generic version of Lamivudine in Brazil by
September 2001.

The originator product 'Epivir' is from Glaxo Smithkline. The branded
medicine costs around R$ 210.55 for 60s and the Ministry of Health (MOH)
expects that the generic version will cost 40% less ( around R$ 126.33).
Epivir is part of the cocktail of medicines distributed free of cost by
MOH.

The target of MOH is to distribute 22 Million of Lamivudine dosages to
the HIV infected patients. The MOH in Brazil procures approximately US$ 500
million worth of drugs annually for free distribution and 70% of this is
allocated for anti-AIDS products.

Ranbaxy S.P.Medicamentos (RSPM), a majority owned Joint Venture
commenced marketing operation in November 2000 and is present in both
Branded and Generic segments. It has set up repackaging and warehousing
facilities along with marketing, sales and distribution infrastructure
to market both branded products and generics. RSPM has many firsts,
against its name- it is the first Indian company to get its
manufacturing plants approved; first Asian company to get its generics
approved by the Ministry & the first Indian company to market its
bio-equivalent generics.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company,
manufactures and markets branded generic pharmaceuticals, bulk
substances and intermediates. Ranbaxy's continued focus on R&D has resulted
in
several approvals in developed markets and significant progress in New
Drug Discovery Research. The company, which has an expanding
nternational portfolio of affiliates, joint ventures and alliances, has
business
operations in over 24 countries and manufacturing operations in 6
countries.

For further information please contact:

Paresh Chaudhry
Tel: 011 91 6002075
Fax: 011 91 6002074
e-mail: pareshc@ranbaxy.co.in

Vinod Dhawan
Regional Director
Asia-Pacific, Latin America & Canada
Tel: 011 91 6466691
Fax: 011 91 6002087
e-mail: vinodd@ranbaxy.co.in


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