Gilead Gives Seven Generic Firms Sovaldi Licenses for Developing World

Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy.

Gilead announced nonexclusive licensing agreements for generic Sovaldi (sofosbuvir) Monday with Cadila Healthcare, Cipla, Hetero Labs, Mylan, Ranbaxy, Sequent Scientific and Strides Arcolab.

Each firm will be able to manufacture and distribute generic Sovaldi, as well as an investigational single tablet regimen of ledipasvir/sofosbuvir, in countries that include India, South Africa, Egypt and Indonesia, according to the firms.

The agreements call for Gilead to provide each licensee with the full Sovaldi technology process needed to produce both API and finished generic product, the companies said. Each firm will set its own price while paying Gilead an unspecified royalty.

More than 100 million people in the 91 covered countries have hepatitis C, about 54 percent of all those living with the disease worldwide, according to the companies. Gilead touted the licensing agreements as a way to expand access to the therapy.

The licensing agreements come amid considerable backlash against Gilead for how the brandmaker has priced Sovaldi in the developed world. Approved by the FDA in December and the European Commission in January, the drug generated $5.75 billion in sales in the first half of 2014 and is priced at $84,000 for a 12-week treatment.

No indication was given for when generic launch might occur or how much each firm might charge. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.