October 1, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Swiss bipharma behemoth Novartis AG has announced that it will give full rights of its hepatitis C inhibitor to Enanta Pharmaceuticals, Inc. just as the drug, EDP-239, is currently in phase 1 development for the hepatitis C virus.
Enanta Pharmaceuticals works on small molecule drugs in the infectious disease industry. Enanta and Novartis entered a collaboration to advance EDP-239 in February 2012 but now appear to be parting ways as Novartis revamps its portfolio.
“Novartis notified Enanta that as part of an ongoing portfolio transformation, HCV research would no longer be a strategic focus for Novartis,” said Jay Luly, president and chief executive of Enanta Pharmaceuticals. “We appreciate Novartis’ contributions to the clinical development of EDP-239 and its ready agreement to return the NS5A program to us. Enanta is now positioned with three wholly-owned HCV programs from which future drug combinations can be explored.”
EDP-239 inhibits the NS5A non-structural viral protein that is essential to the replication of hepatitis C within the body. The inhibitor has shown that it has additive or synergistic antiviral activity when use in combination with other anti-hepatitis C virus therapeutics.
This new agreement assists with the completion of specified proof-of-concept clinical studies underway involving the inhibitor, a combination study with Alisporivir, and a cyclophilin inhibitor licensed by Novartis.
The Fight Against Hepatitis C
On Sept. 15, Gilead Sciences, Inc. announced that it had entered a entered a non-exclusive licensing agreement with seven Indian-based pharmaceutical companies to expand access to its hepatitis C medications in India and the developing world.
“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,” said Gregg Alton, executive vice president of corporate and medical affairs at Gilead. “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.”
In the countries that entered the agreement with Gilead, more than 100 million people are suspected to be living with hepatitis C. The licensing agreement will allow companies to receive a complete technology transfer of the Gilead manufacturing process to scale up production quickly and efficiently.
The companies will be working to manufacture sofosbuvir, also marketed as Sovaldi, one of the world’s most expensive and popular hepatitis C drugs.
