GREAT SCIENCE. GREAT MEDICINE.
CREATING BREAKTHROUGH TREATMENTS.
HGS is working to create and develop novel therapies that can extend and improve the quality of life. That is our passion.
Three Products in Late-Stage Development
We have three promising products in late-stage development – one already commercialized and two moving toward commercialization. BENLYSTA™ (belimumab) has successfully completed Phase 3 development in systemic lupus. We and GlaxoSmithKline expect to submit marketing applications in the United States, Europe and other regions in the second quarter of 2010.
ZALBIN™ (albinterferon alfa-2b) has successfully completed Phase 3 development in chronic hepatitis C. We have submitted a Biologics License Application to the FDA for ZALBIN in the United States, and have received confirmation that our submission was accepted for filing with a PDUFA target date of October 4, 2010. Novartis has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) under the brand name JOULFERON® in Europe.
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 of raxibacumab to be delivered over a three-year period. We delivered approximately 5,600 doses under the new order in fourth quarter 2009.
High-Potential Pipeline
Right behind these late-stage products is an emerging, high-potential mid-stage pipeline, led by mapatumumab, our TRAIL receptor antibody for cancer. We also have substantial financial rights to a number of products in the GlaxoSmithKline 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.
We are committed to improving the lives of patients – and to achieving commercial success and sustainable growth well into the future.