US-based Gilead Sciences has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical firms to expand the availability of its chronic hepatitis C medicines in 91 developing countries.
Under the deals, Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab will manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir.
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Gilead Sciences corporate and medical affairs executive vice-president Gregg Alton said: "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.
"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 programme in these countries."
The licencing agreements will allow the Indian companies to receive a complete technology transfer from Gilead, related to the products.
Licensees have been provided with the flexibility to set their own prices for the generic product, which they produce. Royalty will be paid to Gilead, based on sales of the product.
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By GlobalDataIn addition, the licences will allow the companies to produce sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
In December 2013, Sofosbuvir received approval from the US Food and Drug Administration, while the European Commission approved the product in January.
According to Gilead, around 100 million people are suffering with hepatitis C in the countries within the agreement, which is around 54% of the total global infected population.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of Maria Teresa Catanese, Martina Kopp, Kunihiro Uryu, and Charles Rice.
