As part of its NDDS programme, Lupin Ltd has developed a once-a-day dosage form of triple combination anti-HIV drugs consisting of Lamivudine, Stavudine and Nevirapine, which forms the first line therapy of drugs in anti-HIV treatment.
The molecule has been developed and the company is currently undergoing negotiations with the WHO for conducting trials of the molecule across 22 high burden countries, mostly in Africa, said, company's chairman, Desh Bandhu Gupta. Lupin has already obtained international patent for the product.
If the trials prove to be successful, Lupin will be the first company in the world to have successfully developed once-a-day (OD) dosage of the combination, as 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. A single trial of the molecule, to study the effects of OD version is mandated," said Gupta.
Currently, the first line triple combination regimen consist of Stavudine or Zidovudine + Lamivudine + Nevirapine. The second line of the combination include 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 cost 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.