Key Developments For Human Genome Sciences, Inc.
Human Genome Sciences, Inc. (HGSI.O) (Consolidated Issue listed on NASDAQ Global Market)
Human Genome Sciences Announces Proposed Public Offering Of Common Stock
Human Genome Sciences announced that it has commenced an underwritten public offering of up to 12,500,000 shares of its common stock. The Company intends to grant the underwriters a 30 day option to purchase up to an additional 1,875,000 shares of the Company's common stock. The shares will be issued pursuant to a prospectus supplement filed as part of a shelf registration statement previously filed with the Securities and Exchange Commission on Form S-3. The Company currently expects to use the net proceeds from this offering for general corporate purposes, including acquisition of additional manufacturing capacity and development of new indications for BENLYSTA, as well as potential sales and marketing activities, clinical trial, research and development, general and administrative and manufacturing expenses and the potential retirement of debt. Goldman, Sachs & Co. and Citigroup Global Markets Inc. are acting as joint book-running managers for the offering.
Human Genome Sciences Submits Biologics License Application To FDA For ZALBIN
Human Genome Sciences 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.
Human Genome Sciences And Aegera Therapeutics, Inc. Announces Initiation Of Clinical Trial Of Lead IAP Inhibitor HGS1029
Human Genome Sciences (HGS) and Aegera Therapeutics, Inc. announced that HGS has initiated osing in a Phase I clinical trial to evaluate the safety and tolerability of its lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors. HGS acquired exclusive worldwide rights (excluding Japan) to develop and commercialize HGS1029 and other IAP inhibitors from Aegera Therapeutics, Inc. in December 2007.
Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application
Human Genome Sciences announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company`s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.
Human Genome Sciences And GlaxoSmithKline Announce Positive Results In Second Of Two Phase Three Trials Of BENLYSTA
Human Genome Sciences and GlaxoSmithKline PLC (GSK) announced that BENLYSTA (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups. The data from the BLISS-76 study were analyzed after 52 weeks, in accord with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. However, the BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
