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Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) today announced that it has signed a non-exclusive licensing agreement with Gilead Sciences Inc, which will allow the generic manufacture of sofosbuvir and ledipasvir (used for treatment of chronic Hepatitis C) for distribution in 90 developing countries, including India.
The company said here in a statement that the agreement would allow Zydus to manufacture the generic versions of sofosbuvir and the investigational single tablet regimen of ledipasvir / sofosbuvir. "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," the statement said.
Pankaj R Patel, chairman and managing director of the Zydus Group said, "By joining hands and providing access to affordable therapy, we are taking a far reaching step towards fighting the scourge of hepatitis C. It is through such joint initiatives and combined efforts that we serve the cause of healthcare."
Zydus Heptiza, the specialty division of the Zydus group will be marketing the therapy. "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," the statement said.
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. The licenses 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.
