Human Genome Sciences (HGS) has submitted a biologics licence application to the US Food and Drug Administration (FDA) for Zalbin, a new treatment for hepatitis C developed in collaboration with Novartis.
HGS and Novartis signed a worldwide co-development and commercialisation agreement entered into in 2006 to co-commercialise albinterferon alfa-2b in the US as Zalbin.
This application includes the results of two pivotal Phase 3 clinical trials, which evaluated albinterferon alfa-2b vs peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naïve patients with chronic hepatitis C.
HGS president and CEO H Thomas Watkins said that assuming licensure by the FDA and other regulatory agencies; HGS believes Zalbin could become an important treatment for chronic hepatitis C.
“Novartis will also target submission of marketing authorisation applications under the brand name Jouleferon in the rest of the world later this quarter, beginning with Europe,” Watkins said.
HGS could still be eligible for as much as $507.5m, on top of the $207.5m received to date from clinical development and commercial milestones as well as other payments.