Novartis Returns HCV Drug Rights, Ends Agreement With Enanta

R&D biotech firm Enanta Pharmaceuticals announced that it will be regaining full rights of investigational hepatitis C treatment EDP-239 from its ex-partner Novartis.

The investigational EDP-239 is a direct-acting anti-viral (DAA) that inhibits replication of hepatitis C virus. EDP-239 demonstrated in vitro activity against major HCV genotypes as well as synergistic potential when combined with other anti-HCV drugs, including direct-acting and host-targeted antivirals. Novartis originally entered into collaboration with Enanta in 2012 to study the drug in combination with alisporivir (DEB025), a cyclophilin inhibitor being developed by Novartis, which Novartis gained through a licensing agreement with Debiopharm.

The partners recently announced that they advanced EDP-239 into combination studies with alisporivir in August. At the time, Enanta President and CEO, Dr. Jay R. Luly, gave no hint as to the impending breakup of the two companies, but rather, was optimistic about the trial’s progress. “The advancement of EDP-239 in partnership with Novartis provides Enanta with another opportunity to participate in additional HCV regimens under development,” he said.

However, Dr. Luly adopted a different tune when he broke the news that Novartis has opted out of the development program for EDP-239. “Novartis notified Enanta that as part of an ongoing portfolio transformation, HCV research would no longer be a strategic focus for Novartis. We appreciate Novartis’ contributions to the clinical development of EDP-239 and its ready agreement to return the NS5A program to us.” He said that Enanta is eyeing other opportunities for development of its three HCV programs.

While there was progress being made in the trials with alisporivir, the road to that success had some hang ups. In 2012, Reuters reported that three cases of acute pancreatitis, one of them fatal, prompted the U.S. Food and Drug Administration (FDA) to place a clinical hold on Novartis’ DEB025 trials in HCV. The company was investigating alisporivir in combination with pegylated interferon and ribavirin for the treatment of HCV at the time.