The mission of Human Genome Sciences is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

Late-Stage Products

We are poised for the market with a clinical pipeline that includes novel products in late-stage development:

• BENLYSTA® (belimumab) has successfully completed Phase 3 development in systemic lupus, and we and GlaxoSmithKline submitted marketing applications in the United States and Europe in June 2010. 
• In May 2009, we submitted a BLA 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.

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. 

Raxibacumab is being developed under a contract with the U.S. Government and represents a new way to address the threat of anthrax. 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. We delivered approximately 4,300 doses under the new purchase order in the first quarter, and expect to deliver a total of approximately 15,000 doses to the Stockpile in 2010.

Mid-Stage Pipeline

Right behind these late-stage products is an emerging 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. GSK is currently conducting Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease and Syncria® (albiglutide) in patients with type 2 diabetes mellitus.

Manufacturing and Process Development

Our manufacturing and process development capability represents a significant strategic advantage. Human Genome Sciences is able to produce and purify multiple protein and antibody drugs in two state-of-the-art process development and manufacturing facilities – totaling approximately 400,000 square feet and offering both small-scale and large-scale production.

Strong Cash Position

Unlike many pre-commercial biopharmaceutical companies, Human Genome Sciences has built a strong cash position that allows us to focus on advancing our lead products toward commercialization as rapidly as possible, while at the same time investing in our early- and mid-stage pipeline. We are committed to achieving and sustaining growth well into the future.