Gilead OKs generic licensing deals in India for Sovaldi

Gilead Sciences has signed licensing agreements that will allow seven Indian pharmaceutical manufacturers to produce generic versions of sofosbuvir to treat patients with hepatitis C virus, according to a news release.

Under the agreements, the licensees can set their own prices for their generic offerings of Sovaldi, paying a portion of sales to Gilead for business support of product registrations, medical education and training and safety monitoring, the release said. The licenses also permit the manufacture of Gilead’s investigational single-tablet ledipasvir/sofosbuvir combination.

The agreements were established with: Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab. The companies distribute their products to 91 developing countries, representing 54% of the worldwide population infected with HCV, according to the release.

“Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible,” Gregg H. Alton, Gilead’s executive vice president of corporate and medical affairs, said in the release. “In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries.”

Sovaldi was approved by the FDA in December 2013 and by the European Commission in January. Applications for a single tablet regimen of ledipasvir/sofosbuvir are currently pending with the FDA and EC, according to the release.