Mylan, Gilead Partner To Bring Cheaper Hepatitis C Treatment To Developing Countries
By Lori Clapper
In a new collaboration with Gilead Sciences, Mylan has won the nonexclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Gilead currently markets Sovaldi, the brand-name version of sofosbuvir, indicated for those with hepatitis C.
Under the licensing agreement, Mylan will manufacture low-cost versions of the medicines for developing markets. The company joins Indian generics companies Cipla, Ranbaxy, along with several others, which Gilead has also granted permission to manufacture generic versions of its $1,000 -a-day treatment.
However, Gilead says it now plans to charge just $300 for a bottle of the pills marketed in India. The generic companies said they would make their version even less expensive, meaning hepatitis C patients in developing countries could pay $10 a day or less for Sovaldi, or 1% of the price that many patients in the U.S. are charged, the Wall Street Journal reported.
"Hepatitis C is a growing public health problem in developing countries, with Central and East Asia and North Africa among the regions most affected by this disease,” Mylan CEO Heather Bresch said. “Unfortunately, patients in these regions often lack access to critical and effective treatments. This agreement with Gilead will allow Mylan to provide early access to a more affordable version of Sovaldi, helping to meet the unmet medical needs of the millions of patients in developing countries who do not currently have access to this life-saving medicine."
The countries which will receive Mylan’s drug products are home to more than 100 million people living with hepatitis C globally, which accounts for 54 percent of the total global infected population, the company announcement said.
Sofosbuvir was approved in the U.S. under the trade name Sovaldi by the U.S. Food and Drug Administration (FDA) in December 2013 and was approved by the European Commission in January 2014 for the recommended treatment option in the World Health Organization's first hepatitis C treatment guidelines. The drug was also recently recommended by the National Institute for Health and Care Excellence (NICE) for those with genotype 1 and genotype 3 (as long as certain qualifications are met) in England.