Gilead Announces Generic Licensing Agreements
News Sep 27, 2014
Gilead Sciences, Inc. has 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.
“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. 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 program in these countries,” commented Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.
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 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.
Methane Hydrate Formation Studied Using Novel MicroreactorNews
Researchers at the NYU Tandon School of Engineering are using a novel means of studying how methane and water form methane hydrate that allows them to examine discrete steps in the process faster and more efficiently.READ MORE
University of Huddersfield Honorary Award Goes to RSC’s First Woman PresidentNews
The first woman President of the Royal Society of Chemistry, Professor Lesley Yellowlees, will collect an honorary award from University of Huddersfield, which will be presented at the University’s November Award Ceremonies.READ MORE
Drug Discovery Alliance Formed to Help Increase Drug Development Success RateNews
Two prominent preclinical safety companies have launched a unique European alliance to address the high safety-related failure rate in drug development.READ MORE