Gilead Sciences enters deals with seven drugmakers for Sovaldi generics

Gilead Sciences on Monday announced non-exclusive licensing agreements allowing seven drugmakers, including Cipla, Mylan and Ranbaxy, to manufacture the hepatitis C therapy Sovaldi (sofosbuvir) for distribution in 91 developing countries. Gregg H. Alton, executive vice president, corporate and medical affairs at Gilead, noted that the company "is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible."

The deals, which were also signed with Cadila Healthcare, Hetero Labs, Sequent Scientific and Strides Arcolab, additionally permit the companies to produce an experimental single tablet regimen combining Sovaldi with ledipasvir. Gilead said that under the agreements, the Indian drugmakers will receive a complete technology transfer of the manufacturing process to enable them to scale up production of the drug as quickly as possible. Gilead indicated that the licensees will be allowed to set their own prices for the generics and pay a royalty on sales.

According to Gilead, the countries covered under the deals account for more than 100 million people living with hepatitis C, representing 54 percent of the total global infected population. "In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines," Alton remarked. The company added that the agreements also allow the Indian drugmakers to manufacture Sovaldi or ledipasvir in combination with other chronic hepatitis C medicines.

Commenting on the deals, Rohit Malpani of Doctors Without Borders said "Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 percent of people with hepatitis C live today." In response, Alton remarked that "there are many people who would like to see more countries added to that list, but that is the list we have agreed upon for these licenses."

Sovaldi was approved by the FDA in December 2013 and gained clearance from the European Commission in January this year. In both markets, regulatory applications for the single tablet regimen of Sovaldi and ledipasvir are under review. In the US, Sovaldi is priced at $1000 per tablet, with a 12-week course of treatment costing $84 000. In India, where people are generally infected with a different strain of the virus, and treatment can take twice as long, the drug is expected to be sold for less than $1800 for a 24-week course of therapy.

Alton indicated that Gilead will introduce Sovaldi in India from about $10 per tablet, while "pricing for Thailand, Mexico or Brazil will be very different than the US price." Bhavesh B. Shah, director of international marketing at Hetero, noted that Gilead's pricing will force the Indian companies to price their generic versions even lower. Shah indicated that the generic products will be available in India during the second or third quarter of 2015 at the earliest.

For related analysis, read ViewPoints: Pharma showing a subtle shift in US drug pricing policy? and Spotlight On: Two's a party, three's a war? Expectations begin to crystalise on if and when a price war could emerge in HCV space.

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