Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor programme. Enanta has received IND approval for EDP-239 from the FDA.

NS5A, a clinically validated target, is a non-structural viral protein that is essential to viral replication. Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development. Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts. EDP-239, Enanta’s lead candidate targeting NS5A was most recently recognized on Windhover’s list of the “Top Most Interesting Infectious Disease Projects to Watch”.

Under the terms of the agreement, Enanta will receive an upfront payment of $34 million and is eligible to receive up to $406 million if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains co-detail rights in the United States. 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, PhD, president & CEO, 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.”

Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.