Indian companies granted licence to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C
US-based Gilead Sciences announced Monday that it has signed licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries.
The agreements were signed with Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. These are non-exclusive licences, which means Gilead holds the rights to keep manufacturing the medicines.
Licences have been granted for drugs sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54 per cent of the total global infected population. “Hepatitis C is a significant public health issue worldwide... In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines," said Gregg H Alton, executive vice-president, corporate and medical affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies will receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production. The licencees will also set their own prices for the generic product they produce, paying a royalty on sales to Gilead. The licences also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi by the US Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014.
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