The Mumbai-based Lupin Ltd is seeking partners for the development and commercialisation of the newly developed once-a-day dosage form of triple combination anti-HIV drugs consisting lamivudine, stavudine and nevirapine, which forms the first line therapy of drugs in anti-HIV treatment.

The company has started talks with some companies for jointly conducting clinical trials as well as marketing of the molecule. Lupin has already obtained international patent for the product, developed as part of its NDDS programme, a senior company executive told Pharmabiz without naming the companies.

If the trials prove to be successful, Lupin will be the first company in the world to develop once-a-day (OD) dosage of the combination. The existing triple combination drugs have to be taken on a twice-a-day dosage basis, he said.

This is anti-TB major Lupin's first entry into the anti-AIDS segment. "Since the drug is an NDDS version of already existing molecules, it is not mandatory to do all three phases of clinical trials," he said.

Currently, the first line triple combination regimen consist stavudine or zidovudine + lamivudine + nevirapine. The second line of the combination includes abacavir + didanosine + lopinavir or saquinavir.

Indian companies like Cipla and Ranbaxy are the pioneers in the development of triple drug combinations in the world. In 2004, Cipla's twice-a-day triple combination Triomune costs around Rs 1,350 per month as against Rs 6,780 per month in 2000. The Pune-based Emcure has recently launched its triple combination for paediatrics at Rs 700 per month of treatment.

Meanwhile, the Rs 1,200-crore Lupin plans to out-license its molecules for migraine, psoriasis and TB, which are under clinical trials.

It is learnt that one pure chemical entity and one herbal entity molecule for psoriasis have cleared the first phase of clinical trials. One herbal entity molecule for migraine and one pure chemical entity molecule for TB are under phase II trials. Once the molecules clear phase II, the company plans will enter into agreements to out-license them.

Other molecules of Lupin for diabetes, anti-bacterial and rumatoid arthritis segments are under pre-clinical phase. It is learnt that Lupin, who has 27 per cent of turnover from its TB drugs, is shifting its focus more on segments like cardiovascular, diabetes and CNS.