The two companies have entered into a generic, non-exclusive licensing agreement to manufacture Sofobuvir and an investigational single tablet regime of Ledipasvir/ Sofobuvir for distribution in 90 developing countries, including India, for treatment of chronic Hepatitis C, according to a press release.
There are nearly 10 million patients suffering from Hepatitis C in India. The problem is further compounded by the fact that patients remain undiagnosed till the late stage and can ill afford the treatment, said Pankaj Patel, Chairman and Managing Director of the Zydus group.
Zydus Heptiza, the specialty division of the Zydus Group, which will be marketing the therapy, has been solely focused on improving treatment access in chronic viral Hepatitis. Over the last four years since launch, Heptiza is the only division present with an entire range of antivirals approved for hepatitis B & C management in India. It has been reaching out to high risk population with free screening for hepatitis B & C patients and has made available hepatitis B vaccination to patients, free of cost.
Under the licensing agreement, Zydus will receive a complete technology transfer of the Gilead manufacturing process to enabling production to be scaled up as quickly as possible. Zydus will set its own prices for the generic product, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other business essential activities. 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 U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir. It is an investigational agent and its safety and efficacy have not been established.