Gilead licenses hepatitis C drugs to 7 India-based pharma cos

US-based drug maker Gilead Sciences Inc today signed licensing agreements for hepatitis C drugs with seven India-based firms, including Cipla, Ranbaxy and Cadila, to make them available in 91 developing countries.
Mylan Laboratories, Sequent Scientific, Strides Arcolab and Hetero Labs are other companies with which non-exclusive licensing agreements have been signed to manufacture generic versions of sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for distribution, Gilead Sciences said.
Under the licensing agreements, the companies will receive a complete technology transfer for Gilead's manufacturing process to enable them to scale up production as quickly as possible.
Commenting on the development, Gilead Sciences Corporate and Medical Affairs Executive Vice President Gregg H Alton said: "Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible."

The 91 countries where the generic versions of Gilead's drugs will be sold include 54 middle-income and 37 low-middle income countries. More than 100 million people with hepatitis C globally reside in these nations, representing 54 per cent of the total globally infected population.
As per the licensing agreement, the companies will be allowed to fix their own price 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 will be launching its own branded Sovaldi in India at a planned price of USD 300 per bottle," Alton said without giving any time line.

The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines, it added.
In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines, he added.
Commenting on the development, Cipla MD & Global CEO, Subhanu Saxena said: "This partnership with Gilead emphasises our ongoing commitment to provide access to medicines for patients when they need it....We look forward to manufacturing the drug in India and offer the drug to patients at a competitive price."
Gilead Sciences said Sofosbuvir was approved under the trade name Sovaldi by the U S Food and Drug Administration (USFDA) in December 2013 and by the European Commission in January 2014.