Gilead Licenses Generic Sovaldi To Hetero, Mylan, Ranbaxy, 4 Others
By Cyndi Root
Gilead Sciences announced in a press release that it has licensed Sovaldi (sofosbuvir) to seven Indian companies. The non-exclusive licensing agreements with generic pharmaceutical manufacturers allows developing countries access to the drug for Hepatitis C. Gilead issued the licenses to Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific, and Strides Arcolab. Gregg H. Alton, EVP of Corporate and Medical Affairs at Gilead Sciences, said, “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.”
Generic Sovaldi Agreements
The agreements that Gilead has made with generic manufacturers is expected to benefit more than 100 million people in 91 countries, over half of the people infected with Hepatitis C worldwide. The agreements allow for the manufacturing of sofosbuvir, a combination of ledipasvir/sofosbuvir, and sofusbuvir in combination with other hepatitis C medications.
Under the terms of the agreements, Gilead will arrange a transfer of the technology needed to produce the medications, including the manufacturing process. The licensees are entitled to scale up production as quickly as possible and set their own prices for the drugs. In return, the licensees will pay royalties to Gilead. Early in September, Mr. Alton said that royalties would be in the single digits, but Gilead did not specify the royalty amounts in this announcement. Gilead will also offer additional support in training, safety monitoring, and business activities.
Sofosbuvir
The Food and Drug Administration (FDA) approved Sovaldi in December 2013, the European Commission approved it in January 2014, and in August 2014, the UK’s National Institute for Health and Care Excellence (NICE) recommended it with limitations. Gilead has come under fire from patients, doctors, regulators, and legislators due to the high cost of the drug.
Gilead’s Humanitarian Programs
Gilead adds the generic Sovaldi program to its list of humanitarian programs. In 2006, the company began licensing HIV drugs to low-income companies. That experience gives Gilead the experience to manage the generic Sovaldi roll-out. Mr. Alton cautioned that, despite the quick deal-making and the fast technology transfer, the drugs still need to go through the regulatory process in each country.