Gilead licenses its Hepatitis C drug to 7 Indian generic pharma companies

Cadila Healthcare Ltd (Zydus Cadila) on Monday said it has been granted generic licence by Gilead Sciences Inc, to manufacture breakthrough treatment of Hepatitis C.

Gilead Sciences Inc on Monday said it 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 company said in a release.

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, it added.

''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 programme in these countries,'' said Gregg H Alton, executive vice president, corporate and medical affairs, Gilead Sciences.

Under the licensing agreements, the Indian companies receive complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees can set their own prices for the generic product they produce, paying a royalty on sales to Gilead, which will support product registrations, medical education and training, safety monitoring and other essential business activities, Gilead said.

The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines, it added.

Sofosbuvir was approved under the trade name `Sovaldi' by the US 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.

The companies have also entered into non-exclusive licensing agreement to manufacture the medicines for distribution in 90 developing countries, including India, for treatment of chronic Hepatitis C, according to a release.

There are nearly 10 million patients suffering from Hepatitis C in India. The problem is further compounded by the fact that patients remain undiagnosed till the late stage and can ill afford the treatment, said Pankaj Patel, Chairman and Managing Director of the Zydus group.