Novartis submits JOULFERON MAA to the EMEA

Dec 15 2009

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Novartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C. In November 2009, HGS submitted a Biologics License Application (BLA) for ZALBIN to the FDA in the United States.

The MAA submission includes the results of two pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) dosed once each week. The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, 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. In both studies, albinterferon alfa-2b, with half the injections, achieved sustained virologic response comparable to that achieved by peginterferon alfa-2a. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2255 patients.

“Assuming licensure by the EMEA and other regulatory agencies, HGS believes JOULFERON could become an important treatment for chronic hepatitis C,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We look forward to continuing to work closely with Novartis to advance albinterferon alfa-2b to the market under the brand name ZALBIN in the United States.”