Novartis, Enanta In HCV Pact

Enanta Pharmaceuticals and Novartis have entered into an exclusive collaboration and license agreement for the worldwide development, manufacture and commercialization of Enanta’s lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. NS5A is a non-structural viral protein that’s essential to viral replication. Research has shown that targeting NS5A provides significant antiviral activity. Enanta received IND approval for the drug from the FDA.

Enanta will receive $34 million upfront and is eligible to receive as much as $406 million in clinical, regulatory, and commercial milestones. Enanta is also eligible to receive royalties on worldwide sales and retains co-detail rights in the U.S. Novartis will be responsible for all costs associated with the development, manufacture and commercialization of EDP-239 and will fund Enanta’s drug discovery efforts on certain additional compounds targeting NS5A.

“Novartis is a recognized leader in the field of HCV, and access to its global expertise combined with our shared vision for commercializing HCV therapies will support the successful development and commercialization of products targeting NS5A,” said Jay R. Luly, Ph.D., president and chief executive officer of Enanta Pharmaceuticals. “We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans.”