In a move to make the treatment for Hepatitis C more affordable in developing markets, U.S. pharmaceutical major Gilead Sciences, on Monday, signed non-exclusive licensing agreements with seven Indian generic pharmaceutical companies to manufacture it.
Gilead signed agreements to make sofosbuvir and the investigational single tablet regimen of ledipasvir / sofosbuvir for distribution in 91 developing countries.
A statement from the company said it signed agreements with Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.
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.
According to World Health Organization, 130-150 million globally have Hepatitis C infection and in India alone, it is estimated that 10-20 million patients are infected with Hepatitis C which is several fold greater than those with HIV/AIDS. A large number of patients develop liver cirrhosis and liver cancer.
Sofosbuvir is considered a breakthrough and in combination therapy has high cure rates. Sofosbuvir was approved under the trade name Sovaldi by the U.S. Food & Drug Administration (FDA) in December 2013 and by the European Commission in January 2014.
Technology transferGilead said the FDA and European Medicines Agency were now reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir, an investigational agent and its safety and efficacy had not yet been established.
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 as quickly as possible.
“The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities,” Gilead said. The licences also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic Hepatitis C medicines.
“In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian programme in these countries,’’ Gregg Alton, EVP, Corporate & Medical Affairs, Gilead Sciences, said in a statement.
