At Human Genome Sciences, we believe that solving critical medical challenges takes careful planning, relentless resilience, the best scientific minds, and rigorous clinical trials. Success will come by design – and by working systematically to achieve breakthrough results one careful step at a time.
Lead Products
We received our first product approval in the United States from FDA on March 9, 2011 – when BENLYSTA® became the first new approved drug for lupus in more than fifty years. The FDA approval of BENLYSTA was based on data from the largest clinical trial program ever conducted in patients with systemic lupus. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and co-commercialization agreement entered into in 2006. 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.
Raxibacumab is being developed under a contract with the U.S. Government and represents a new way to address the threat of inhalation anthrax. In 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. 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.
Mid-Stage Pipeline
Right behind these late-stage products is an emerging 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. GSK is currently conducting Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease and albiglutide in patients with type 2 diabetes mellitus.
Manufacturing and Process Development
Our manufacturing and process development capability represents a significant strategic advantage. HGS 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
HGS 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.
