The mission of HGS 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 three novel products in late-stage development:
- BENLYSTA™ (belimumab) has successfully completed one of two pivotal Phase 3 trials in systemic lupus, and we expect results from the second Phase 3 trial of BENLYSTA on November 2, 2009;
- ZALBIN™ (albinterferon alfa-2b) has successfully completed two Phase 3 trials in chronic hepatitis C, and submission of global marketing authorization applications for ZALBIN is planned for fourth quarter 2009;
- Raxibacumab is currently pending priority review by FDA for inhalation anthrax.
We believe both BENLYSTA and ZALBIN have the therapeutic potential to change and save lives and, assuming regulatory approval, the commercial potential to become leading products in the marketplace. Each is being co-developed and commercialized in collaboration with a world leader in the pharmaceutical industry – GlaxoSmithKline (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. In July 2009, we secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the U.S. Strategic National Stockpile over a three-year period. In May, we submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. The FDA has notified us that our BLA has been filed and will receive priority review.
Mid-Stage Pipeline
Right behind these three late-stage products is a high-potential mid-stage pipeline led by our TRAIL receptor antibody HGS-ETR1 (mapatumumab) for cancer. We also have substantial financial rights to a number of products in the GSK pipeline. GSK has initiated Phase 3 clinical trials of darapladib in men and women with chronic coronary heart disease, and Syncria® (albiglutide) in type 2 diabetes.
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
Unlike many pre-commercial biopharmaceutical companies, 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.