Steroid-induced osteoporosis can now be treated with Teriparatide
May 18, 2017
HGS will host a conference call to discuss topline 52-week results of the second Phase 3 trial of BENLYSTA, BLISS-76, on Monday, November 2, 2009, at 8:15 AM Eastern. Investors may listen to the call by dialing 800-753-9057 or 913-312-0718, passcode 9331404, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 9331404.
Assuming the 52-week results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
New Order Received from U.S. Government for Raxibacumab; $152 Million in Revenue Expected over Three-Year Period; Completion of BLA Review Pending
In July 2009, HGS announced that the U.S. Government exercised its option to purchase 45,000 additional doses of raxibacumab for the Strategic National Stockpile, to be delivered over a three-year period, beginning near the end of 2009. HGS expects to receive approximately $152 million from this award as deliveries are completed. This order is in addition to the 20,000 doses that were delivered to the Stockpile earlier this year. HGS is developing raxibacumab under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services.
In May 2009, a biologics license application (BLA) was submitted to the FDA. The application was subsequently accepted and granted priority review. On October 27, 2009 the Anti-Infective Drugs Advisory Committee to the FDA met to discuss certain aspects of the BLA. HGS continues to work with the FDA towards a successful completion of the review.
$75 Million Development Milestone Earned for ZALBIN?„? Progress; Submission of Global Marketing Applications Planned for Fourth Quarter 2009
On October 19, 2009, HGS announced that it has earned a $75 million milestone payment from Novartis, related to successful completion of the Phase 3 development program and the decision to submit applications seeking regulatory approval to market ZALBIN?„? (albinterferon alfa-2b) for the treatment of chronic hepatitis C.
HGS and Novartis have completed pre-submission meetings with the FDA and European regulatory agencies, and plan to submit marketing applications for albinterferon alfa-2b in the fourth quarter of 2009. ZALBIN will be the brand name for albinterferon alfa-2b in the United States. JOULFERON?® will be the brand name in the rest of the world. These brand names will be subject to confirmation by health authorities at the time of product approval.
Net Proceeds of Public Offering Total $356.5 Million
In August 2009, HGS completed the public offering of 26,697,250 shares of common stock at $14.00 per share. The Company??™s net proceeds from the offering were approximately $356.5 million after the underwriting discount and estimated offering expenses.
hgsi/