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.