Gilead seals generic Sovaldi deal with Natco, NICE rec for Harvoni in UK
- Gilead has reached a deal with India-based Natco Pharma to sell generic Sovaldi (sofosbuvir), generic Harvoni (combo sofosbuvir and ledipasvir), as well as an experimental drug, GS-5816, in 91 developing countries. An ocean away, the UK's National Institute for Health and Care Excellence (NICE) announced that it would be recommending approval of Harvoni, which is priced a third less than its cost in the U.S. (about $58,400 for a 12-week course in the UK).
- Gilead and Natco may have sealed this deal. But there have been long-simmering tensions regarding Natco (and other companies) copy-catting Gilead's new oral hepatitis C treatments. Previously, Natco had attempted to block Gilead from getting patents in India.
- Natco is one of seven generics manufacturers in India which have entered into similar arrangements with Gilead.
In January, Gilead announced that its patent claims in India for Sovaldi had been denied. The rejection came as multiple India-based companies, including Natco Pharma and the NGO Delhi Network of Positive People, staked out opposition to the patent claim.
The underlying conflict is directly related to price and the outrage over the $1,000-a-day Sovaldi—pricing that leads to an $84,000, 12-week price tag for the hepatitis C treatment. At issue, according to Gilead's critics are the 150 million hepatitis C-infected people worldwide,many of whom live in low- or middle-income countries. What's more, with $1.7 billion in Q4 2014 revenues for Sovaldi, Gilead is continually accused of price-gouging.
In the last six weeks, things have changed as various companies have made deals with Gilead to manufacture and distribute generic version of three of their hep C drugs, while giving back a portion in royalties to Gilead. Many believe that it's a step in the right direction. And the company announced that it's been striking sizeable deals with payers in the U.S. and abroad to make their hep C pills easier to swallow from a cost perspective.