Corporate Profile


<< Back

Human Genome Sciences (Nasdaq: HGSI) is a commercially focused biopharmaceutical company with one potentially major product approved by FDA in March 2011 and a broad pipeline of novel drugs in late- and mid-stage development.

Therapeutic and Commercial Potential

BENLYSTA® (belimumab) is the first new approved drug for lupus in more than fifty years.

  • GSK submitted a Marketing Authorization Application (MAA) for BENLYSTA to the European Medicines Agency (EMA) in June 2010, and a decision on European approval is expected in the second half of 2011.
  • Regulatory applications have also been submitted and are currently under consideration in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.

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.

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, we secured a new purchase order for 45,000 additional doses to be delivered over a three-year period. Approximately 21,000 doses have been delivered to date under the new purchase order, and we expect to deliver approximately 15,000 additional doses to the Stockpile in 2011.

Emerging Pipeline


Right behind these late-stage products is a high-potential mid-stage pipeline focused on immunology and oncology and including potential additional indications for BENLYSTA. We also have substantial financial rights to a number of products in the GSK clinical pipeline.

Strong Partners


Strategic partnerships are a strong driver of our commercial success. BENLYSTA is partnered with GlaxoSmithKline, a world leader in the pharmaceutical industry. Raxibacumab is being developed under a contract with the U.S. Government and represents a new way to address the threat of inhalation anthrax.

Financial Performance


We are committed to excellence in our financial performance, and to achieving and sustaining growth well into the future. Our cash position remains strong, with approximately $933 million in cash and investments as of December 31, 2010.