Human Genome Sciences submits BLA for ZALBIN

Nov 25 2009

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C. The BLA 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.

“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,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Assuming licensure by the FDA and other regulatory agencies, HGS believes ZALBIN could become an important treatment for chronic hepatitis C. Novartis targets submission of marketing authorization applications under the brand name JOULFERON® in the rest of the world later this quarter, beginning with Europe.”

About the Collaboration with Novartis

Under an exclusive worldwide co-development and commercialization agreement entered into in 2006, HGS and Novartis will co-commercialize albinterferon alfa-2b in the United States as ZALBIN™, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization of albinterferon alfa-2b as JOULFERON® in the rest of the world, and will pay HGS a royalty on those sales. These brand names will be subject to confirmation by health authorities at the time of product approval.

HGS has primary responsibility for the bulk manufacture of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $207.5 million received to date. The remaining payments to HGS under the agreement relate to the achievement of certain regulatory approval and commercial milestones.