Date: 2014-09-15
Type of information: Licensing agreement
Compound: sofosbuvir and edipasvir/sofosbuvir
Company: Gilead Sciences (USA - CA) Cadila Healthcare (India) Cipla (India) Hetero Labs (India) Mylan Laboratories (indian subsidiary of Mylan, USA - PA) Ranbaxy Laboratories (India) Sequent Scientific (India) Strides Arcolab (India)
Therapeutic area: Infectious diseases
Type agreement: licensing
Action mechanism:
Disease: hepatitis C
Details: * On September 15, 2014, Gilead Sciences announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies – Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. – to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries. The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population.
Under the licensing agreements, the Indian companies 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. 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 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
Financial terms:
Latest news:
