[Pharm-policy] Cipla and Generic nevirapine

[James Love]

---------- Forwarded message ----------
Date: Tue, 21 Mar 2000 11:15:55 -0500 (EST)
From: Richard Jefferys <richard@atdn.org>
Reply-To: healthgap@CritPath.Org
To: Multiple recipients of list <healthgap@CritPath.Org>
Subject: Generic nevirapine! 

http://www.financialexpress.com/fe/daily/20000321/fco21025.html

Tuesday, March 21, 2000

Cipla bags drugs controller approval to manufacture, market anti-AIDS pill

Anju Ghangurde

MUMBAI, MARCH 20: The Mumbai-based Cipla has got clearance from the Drugs
Controller General of India to manufacture and market the country's first
non-nucleoside reverse transcriptase inhibitor (NNRTI), nevirapine, for the
treatment of AIDS.

Cipla's product, to be branded Nevimune, is being priced at a 150 per cent
discount to the imported nevirapine version, and marks a major breakthrough
for AIDS treatment in India. HIV drugs are, depending on their mode and
site of their action, classified into nucleoside transcriptase inhibitors
(NRTIs), NNRTIs, and protease inhibitors (PIs). Cipla chairman and managing
director YK Hamied said that Nevimune, priced at Rs 135 per tablet, comes
at a discount of around 150 per cent compared with the international prices
of $8 (Rs 344) per tablet. Nevimune's arrival ensures the availability of
all the three main components (that is, two
NRTIs-lamivudine/zidovudine/stavudine and one NNRTI) of AIDS starter
therapy at affordable prices for millions of patients in India.

Cipla took around two years to develop the product (from the basic stage)
at an investment of about Rs 5 crore. The domestic market for Nevimune is
estimated to be worth Rs 50 crore.

The company, Hamied added, is also working in tandem with the CSIR for two
more anti-AIDS drugs.

The original patent for nevirapine is held by Boehringer Ingelheim, and its
brand, Viramune, notched up sales of around $500 million. The patent on
nevirapine expires around 2010. Cipla's move is significant, given that
Nevimune can bring down government spending on AIDS therapy in countries
looking at enforcing compulsory licensing under the provisions of the TRIPS
agreement. On an average, the triple therapy (a combination of three
anti-AIDS drugs, including, say, Viramune) treatment would cost $15,000 per
annum. However, Cipla whole-time director Amar Lulla said that this cost of
treatment could be reduced by at least one-sixth using its domestic product
range.

Moreover, recent studies in Africa have shown that administering just a
single dose of nevirapine during labour, and a second one to new-borns
within 72 hours of birth, reduces the risk of transmission of the AIDS
virus by almost 50 per cent. Experts add that the development of the single
dose of nevirapine given to the mother and baby could be a key step in
preventing mother-to-child transmission in countries with poor resources.
It may also have major implications for the development of public health
policies.

According to Lulla, the company is exporting the active ingredient in
nevirapine to Latin American countries, while the other AIDS drugs in
Cipla's basket, like lamivudine, stavudine, and zidovudine, have been
granted registration in certain African nations. Scientists have long been
baffled by the ability of the HIV virus to adapt itself and develop
immunity against any single drug administered. HIV drugs are, hence, given
as a combination of two NRTIs and one PI, or two NRTIs and one NNRTI.

In India, PIs are imported, and are expensive compared to NNRTIs.
Scientific debate, however, continues on the appropriateness of including a
PI in the starter combination.

While PIs are powerful drugs and achieve a reduction in the viral load,
there are fears that exposing the virus early to the drug may induce
resistance, denying the patient the option of other PI drugs during the
later stage of the disease. Meanwhile, Cipla's Novel Drug Delivery System
for the anti-ulcerant, omeprazole, is under clinical evaluation in New
Zealand, and indications are that plans to license out the product would be
considered only after the results are clear.




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