Date: 2014-10-01
Type of information: Termination of an agreement
Compound: EDP-239
Company: Novartis (Switzerland) Enanta Pharmaceuticals (USA - MA)
Therapeutic area: Infectious diseases
Type agreement: licensing development manufacturing production commercialisation
Action mechanism: EDP-239 is a direct-acting anti-viral (DAA) that inhibits replication of HCV. EDP-239 is an NS5A inhibitor. The compound has demonstrated potent activity against major genotypes in the replicon assay, which is a common in vitro test for determining the potency of an active compound in reducing HCV replication. In addition, EDP-239 has additive to synergistic antiviral activity when used in combination with other anti-HCV therapeutics in the replicon assay. Preclinical studies support excellent permeability and absorption potentials in humans, with preferential targeting to the liver, which is the target site of infection. Human pharmacokinetic and pharmacodynamic modeling suggests a low, once-daily dose for future clinical testing.
Disease: hepatitis C
Details: * On February 21, 2012, Enanta Pharmaceuticals, a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced that it 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 program. Enanta has received IND approval for EDP-239 from the FDA.
Financial terms: 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.
Latest news: * On October 1, 2014, Enanta Pharmaceuticals announced that the company has entered into an agreement to regain full rights from Novartis to EDP-239, an NS5A inhibitor currently in phase 1 development for hepatitis C virus (HCV). “Novartis notified Enanta that as part of an ongoing portfolio transformation, HCV research would no longer be a strategic focus for Novartis,” stated Jay R. Luly, Ph.D., President and CEO. The new agreement provides for the completion or transition to Enanta of specified proof-of-concept clinical studies currently underway involving EDP-239, and a combination study with EDP-239 and Alisporivir, a cyclophilin inhibitor licensed by Novartis from Debiopharm. * Novartis initiated a Phase 1 clinical trial of EDP-239 in November 2012.
