Novartis nabbed exclusive, worldwide rights to Debiopharm’s Debio 025 for the treatment of hepatitis C. The deal covers global development, commercialization, and marketing, excluding Japan. Novartis will pay an undisclosed up-front fee plus milestones and future sales royalties.
Debio 025, a cyclophilin inhibitor, is currently undergoing a Phase II trial in combination with peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1. Debiopharm claims the drug has chemical features in common with cyclosporine A but without the immunosuppressive pharmacological effect. Debio 025 has also demonstrated potent antiviral activity against a broad range of HCV genotypes, a high barrier to resistance development, and offers the potential of once-daily dosing, the firm adds.
Novartis already has an HCV drug candidate albinterferon alfa-2b under regulatory review in the U.S. and Europe. The drug has been developed under an exclusive, global agreement with Human Genome Sciences (HGS) (www.hgsi.com), signed in 2006. Albinterferon alfa-2b is a genetic fusion of human albumin and interferon alfa created using HGS’ albumin-fusion technology.
Novartis submitted an MAA for the therapy in December 2009, and HGS submitted the BLA in November. If approved, the drug will be branded Joulferon in Europe and Zalbin in the U.S.
In addition to its HCV therapeutics pipeline, Novartis’ vaccines business also has interests in the development of potential HCV vaccines. It currently has collaborations with Intercell, CSL, and the Saint Louis University. The company’s partnership with Intercell includes a Phase II-stage therapeutic HCV vaccine that combines five synthetic T cell stimulating peptides and Intercell’s poly-arginine adjuvant.