Pune-based Indus Biotech would be starting clinical trials for its HIV botanical drug molecule in the US soon. The company claims this antiviral has also shown promising results for the pandemic H1N1 during initial clinical trials. Indus, founded by Sunil Bhaskaran and Rajan Srinivasan in 1997, is two to three weeks away from completion of the phase-I trials for a botanical drug that the company claims could kill both H1N1 and HIV viruses.

Indus is also the first Indian company to have received an Investigational New Drug Number from the US Food and Drug Administration for a botanical anti-viral in HIV research. This permits Indus to conduct further clinical trials related to the drug in the US, the only country in the world that has clear guidelines on botanical drugs.

Once the company compiles data from its phase-I study, it would finalise with USFDA the modalities associated with the clinical trials. ?Since the area is uncharted territory, we would have to debate the protocol for advanced clinical trials. If the USFDA limits the subject strength to 20-25, we would manage from our company funds. If they ask us to test on 200 to 500 subjects, we would have to raise funds through PE players, fresh or existing or other means,? Srinivasan told FE. Trials on each subject could cost between $20,000 to $30,000.

Two of company?s applications are also being reviewed by DCGI. “Post approval, the clinical trials studies for H1N1 would take five to seven months, while for HIV they would take 18 to 24 months,” said Srinivasan.

The drug, which the company estimates would cost a fraction of anti-retroviral therapy (ART), the current first-line therapy for AIDS, is expected to hit the market in two years from now. ART costs Rs 20,000 to Rs 25,000 per unit per person annually in India. “However it is difficult to comment on the cost now, which would be decided by the marketing partner to who we outlicense the drug. Once the drug is ready to be commercialised, we would start discussions with companies strong in antivirals and anti-infectives,” said Srinivasan. Saying investment in the drug is “significant”, he refused to divulge any figures.