Hyderabad-based Hetero Drugs has recently signed an agreement with UNITAID promoted Medicines Patent Pool, to make HIV medicines for developing countries.
As per the agreement, Hetero can make four medicines, originally developed by U.S. pharma giant Gilead Sciences: cobicistat, emtricitabine, elvitegravir and a combination (including these three drugs), and tenofovir in a single pill, called, the “Quad’’. These were licensed to the Medicines Patent Pool by Gilead last year.
Speaking to this correspondent, company Director (Marketing) Srinivas Reddy said, “These are all new molecules in various stages of clinical trials, being conducted by Gilead. We will have to pay royalty as part of the agreement. This process is more desirable as otherwise the compulsory licence granted by countries is a long and laborious process and not all countries agree to it.’’
Hetero is, in fact, the fourth Indian company to obtain a licence from the Medicines Patent Pool; the others being Mylan Labs, Ranbaxy Laboratories and Strides Arcolab. The Indian manufacturers can make medicines based on emtricitabine and tenofovir.
Under the agreement, Gilead will provide technology as well as funding to help in process improvement to reduce costs.
“A lot depends on the outcome of the trials — the acceptability of the product, the patient response to the treatment and the like.. Based on their success, these could translate into a market size of at least $25 million. For Hetero, it would mean sales of around $10 million. However, the medicines would be launched after 2013-14 only and would be sold at a fraction (about 5 per cent) of the U.S .market price,’’ Mr. Reddy said.
While Hetero can sell tenofovir in several countries where it is now not under patent, cobicistat, elvitegravir and the Quad are new drugs, which are being developed now. With a licence through the Pool, they can be sold much faster in developing countries after regulatory approval.
