Human Genome Sciences
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Human Genome Sciences (Nasdaq: HGSI) is a commercially focused biopharmaceutical company with a broad pipeline of novel drugs that includes promising products in late-stage development – one already commercialized and another moving toward commercialization.

The Company’s primary focus is rapid progress toward the commercialization of its lead drug, BENLYSTA® (belimumab) for systemic lupus.

  • We have successfully completed the Phase 3 development of BENLYSTA. In June 2010, we and GlaxoSmithKline (GSK) submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. 
  • In May 2009, we submitted a Biologics License Application to FDA for raxibacumab for the treatment of inhalation anthrax. We received a Complete Response Letter from the FDA in November 2009 and are working closely with the FDA to obtain approval.

Strong Partners


Both BENLYSTA and our investigational drug for chronic hepatitis C, ZALBIN™, are partnered with world leaders in the pharmaceutical industry – GSK for BENLYSTA and Novartis for ZALBIN. Raxibacumab is being developed under a contract with the U.S. Government and represents a new way to address the threat of inhalation anthrax.

Therapeutic and Commercial Potential


We believe BENLYSTA could become the first new approved drug for lupus in more than fifty years. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.

In the first half of 2009, we achieved our first product sales by delivering 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalation anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses. We delivered approximately 4,300 doses under the new purchase order in the first quarter of this year, and expect to deliver a total of approximately 15,000 doses to the Stockpile in 2010.

Right behind these late-stage products is a high-potential mid-stage pipeline led by our oncology program and including possible new indications for BENLYSTA. We also have substantial financial rights to a number of products in the GSK clinical pipeline.

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