15 July 2016
WASHINGTON – A latest breakthrough treatment for the deadly Hepatitis C virus could soon be available in India as 11 Indian firms have been given licenses by its American manufacturer following an approval from US authorities. The drug called Epclusa which is developed to treat all genotypes of the Hepatitis C virus by Gilead Sciences in its latest breakthrough treatment was last week approved by the US Food and Drug Administration (FDA).The deadly Hepatitis C virus afflicts as many as 150 million people worldwide and possibly 12 million in India.
This pan-genotypic treatment does not require gene-type testing, eliminating the need for costly gene-type diagnostics, allowing doctors and specialists the ability to prescribe the medicine to anyone who tests positive for Hepatitis C, by taking one pill a day for 8-12 weeks before a cure is achieved. The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype.
Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens. As part of its effort to make it an affordable treatment, Gilead Sciences, together with its 11 partners in India, are pioneering a Voluntary Licensing model that transfers technology and Intellectual Property for latest treatments and cures for viral Hepatitis and HIV.
Gilead, in 2014, licensed its newly-approved HCV regimens to 11 of India’s pharmaceutical companies, including the prospective Epclusa, which had not yet been cleared by the US FDA. “This forward thinking strategy opened for these Indian companies the market across all of India for generic versions of these drugs, plus the market for 100 other countries,” an industry source said. Because of India’s capabilities in generic manufacturing, where quality and low cost co-exist hand in hand, Gilead Sciences recognised that to expand patient access and to deploy these life-saving cures to low income countries around the world to the patients who need treatment most. It would be mutually beneficial to license the Intellectual Property for its new HCV medicines to companies in India which had already established supply chain linkages with countries across Africa, Asia, Eastern Europe, Mongolia, and other hard to penetrate markets, industry sources said.