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HCV regimen candidate licensed by international pharmaceutical company
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Gilead Sciences Inc. will grant Mylan Laboratories Limited, a subsidiary of international pharmaceutical company, Mylan Inc., the non-exclusive rights to produce and sell NS5A inhibitor GS-5816 combined with sofosbuvir in 91 developing countries as soon as the treatment is approved, according to a press release.
The safety and efficiency of sofosbuvir (Sovaldi, Gilead), a recommended treatment option of the World Health Organization, combined with GS-5816, an investigational pan-genotypic agent, is currently being tested in a phase 3 clinical trial expected to end later this year. If successful, it would be the first single oral tablet regimen that could treat all six genotypes of hepatitis C, a remedy that would benefit patients in developing countries where genotype testing is not readily available, according to the release.
“We are proud to partner with Gilead, once again, in our joint effort to quickly expand access to high quality, affordable medications to the more than 100 million people living with hepatitis C in developing countries,” Rajiv Malik, president of Mylan Inc., said in the release. “The potential to offer the sofosbuvir/GS-5816 regimen is particularly exciting, as it is an innovative compound that is being studied to treat all hepatitis C genotypes — a medical advancement that could significantly increase access to treatment.”
Mylan and Gilead have another licensing agreement that provides Mylan with the non-exclusive rights to produce and sell sofosbuvir and ledipasvir/sofosbuvir.