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Human Genome Sciences 2008 Annual Report

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Human Genome Sciences 2008 Annual Report Human Genome Sciences 2008 Annual Report from vision to reality Moving forward with positive results ABthrax™ for Albuferon® for LymphoStat-B® inhalation anthrax chronic hepatitis C for lupus In January 2009, HGS began In December 2008 and March 2009, In 2008, HGS completed the delivery of 20,000 doses of ABthrax HGS reported positive results from enrollment of BLISS-52 and BLISS-76, (raxibacumab) to the U.S. Strategic the Phase 3 trials of Albuferon the largest clinical trials ever con- National Stockpile for emergency use (albinterferon alfa-2b) in chronic ducted in lupus patients. These Phase 3 in the treatment of inhalation anthrax. hepatitis C. Albuferon met its primary trials of LymphoStat-B in systemic The Company expects to receive endpoint of non-inferiority to Pegasys lupus erythematosus are the only at least $155 million from this sale (peginterferon alfa-2a) in both Phase 3 Phase 3 trials in lupus whose design in 2009, with most of the revenue trials. The results of both studies was directly informed by randomized expected in the first quarter. HGS will demonstrate that, with half the Phase 2 results. HGS expects to receive an additional $10 million after injections, 900-mcg Albuferon report the first Phase 3 data for FDA licensure of ABthrax. achieved efficacy comparable to LymphoStat-B in July 2009 from the Pegasys with a positive safety profile. BLISS-52 trial, and results from Global marketing applications are BLISS-76 in November 2009. planned in fall 2009. NAME INDICatiON DEVELOpmEnt StagE PhasE 1 PhasE 2 PhasE 3 TO MarKET ABthrax™ Anthrax Albuferon® Hepatitis C LymphoStat-B® SLE HGS has begun delivery of ABthrax to the U.S. Strategic TRAIL-R mAbs Cancer National Stockpile HGS1029* Cancer for use in the treatment of LymphoStat-B Additional Autoimmune inhalation anthrax Darapladib** Atherosclerosis Syncria®** Diabetes *Formerly AEG40826 **GSK Pipeline On the cover: Cover (L to R): 1. Hepatitis C virions or virus particles. 2. Craig Malzahn, Director, Supply Chain, and Thi-Sau Migone, Senior Director of Clinical Immunology, who have each played major roles on the ABthrax program. 3. HGS has world-class biologicals process development and manufacturing capabilities. 4. Vials of ABthrax ready for packing and shipment. First Product Sales ABthrax, our first-in-class treatment for inhalation anthrax, has begun delivery—marking Human Genome Sciences’ first product sales. Two more novel therapies, Albuferon for hepatitis C and LymphoStat-B for lupus, are progressing rapidly toward commercialization. In addition, HGS has substantial financial rights to darapladib for cardiovascular disease and Syncria® for type 2 diabetes—both of which GlaxoSmithKline has advanced to Phase 3 development. All five of these late-stage products have the therapeutic potential to change and improve the lives of patients and the commercial potential to achieve positions of market leadership. diverse product portfolio We look forward to the filing of global marketing on track for commercialization applications for Albuferon in fall 2009 following discussions with regulatory authorities. Assuming licensure by the FDA and other regulatory agencies, we believe Albuferon could become a market-leading treatment for chronic hepatitis C. partnerships, collaborations To Our Shareholders: For several years now, we have moved Human the treatment of inhalation anthrax and with half the injections, 900-mcg Albuferon Genome Sciences milestone-by-milestone plays an important role in strengthening achieved efficacy comparable to peginter- along the path toward our goal of becoming a America’s arsenal against bioterrorism. feron alfa-2a, with a positive safety profile. biopharmaceutical company with important We will receive at least $155 million in This completes the Phase 3 program for products on the market and multiple revenue in early 2009 under our contract Albuferon, which is being developed by opportunities to drive future growth. We now with the Biomedical Advanced Research HGS and Novartis under an exclusive have that goal in sight, and we are committed and Development Authority of the U.S. worldwide co-development and commercial- to achieving it in the near term. Department of Health and Human ization agreement entered into in June 2006. HGS has a broad pipeline of novel, high Services—with most of the revenue to We look forward to the filing of global quality products, including five in come in the first quarter. In addition, we marketing applications for Albuferon in fall late-stage development. Most of these plan to file a Biologics License Application 2009 following discussions with regulatory products are directed to large markets with in the second quarter of 2009, and we will authorities. Assuming licensure by the FDA significant growth, including hepatitis C, receive an additional $10 million after FDA and other regulatory agencies, we believe lupus, cardiovascular disease and diabetes. licensure of ABthrax. that Albuferon could become a market- All five products are making excellent leading treatment for chronic hepatitis C. progress toward commercialization, with We are pleased with the progress of our the therapeutic potential to change and partnership with the U.S. Government on LymphoStat-B® improve the lives of patients and the ABthrax, and we are hopeful that fulfill- commercial potential to achieve positions ment of this initial order will result in a In 2008, we completed the enrollment of of market leadership. long-term relationship involving additional BLISS-52 and BLISS-76, the largest clinical deliveries of ABthrax to the Stockpile. trials ever conducted in lupus patients. These 2008 was a year of substantial accomplish- Phase 3 trials of LymphoStat-B (belimumab) ment for HGS, and we believe 2009 will be Albuferon® in patients with active systemic lupus a pivotal year for our Company, as our erythematosus (SLE) are the only Phase 3 In December 2008, we reported positive products continue to advance toward the trials in lupus whose design was directly results from ACHIEVE 2/3, our Phase 3 market and we continue to move aggres- informed by randomized Phase 2 results. sively toward turning our vision for HGS clinical trial of Albuferon (albinterferon into reality. alfa-2b) in treatment-naive patients with We expect to report the first Phase 3 data genotypes 2 and 3 chronic hepatitis C. for LymphoStat-B in July 2009 from the Earlier this month, we reported positive BLISS-52 trial, and results from BLISS-76 ABthrax™ results from ACHIEVE 1, our Phase 3 trial in November 2009. LymphoStat-B is being In January 2009, we achieved the first in treatment-naive patients with genotype 1 developed by HGS and GlaxoSmithKline product sales in our history, when we chronic hepatitis C. (GSK) under a co-development and initiated the delivery of 20,000 doses of commercialization agreement entered into ABthrax (raxibacumab) to the U.S. Strategic Albuferon met its primary endpoint of in August 2006. National Stockpile for emergency use in the non-inferiority to peginterferon alfa-2a treatment of inhalation anthrax. We believe (Pegasys) in both of our Phase 3 trials. The If LymphoStat-B is successful in Phase 3, ABthrax offers a significant step forward in results of both studies demonstrate that, we expect to file marketing applications in 2 Darapladib and Syncria: Phase 3 Development Programs Underway In December 2008, GSK initiated the first In February 2009, GSK advanced Syncria to Phase 3 clinical trial of darapladib in more Phase 3 development to evaluate its efficacy than 15,000 men and women with coronary and safety in the long-term treatment of heart disease. Darapladib was discovered by type 2 diabetes mellitus. HGS created Syncria GSK based on HGS technology. and licensed it to GSK in 2004. the United States and Europe in the first We licensed Syncria to GSK in 2004, and cancer cells resist apoptosis and resume half of 2010, and we believe it could we are entitled to fees and milestone growth and proliferation. become the first new drug approved by the payments that could amount to as much as We will continue to pursue these opportu- FDA for the treatment of lupus in 50 years. $183 million—including $33 million we nities by studying HGS-ETR1 and our IAP have already received. We are also entitled inhibitors both in combination with one to single-digit royalties on worldwide sales Darapladib another and in combination with other if Syncria is commercialized. In December 2008, GSK initiated the first therapeutic agents. Phase 3 clinical trial of darapladib in more than 15,000 men and women with Oncology Program Financial Progress coronary heart disease. This trial, which Our earlier- and mid-stage pipeline is also The priority focus of HGS has been GSK calls STABILITY, will evaluate the progressing well. We are investing strategi- constant for the last several years—the efficacy and safety of treatment with cally to expand and advance our oncology commercialization of our late-stage darapladib to reduce the risk of cardiovas- portfolio, building on our leading expertise products and the completion of our cular events in these patients. in the apoptosis, or programmed cell death, Company’s transformation into a strong, pathway. HGS-ETR1 (mapatumumab) is Darapladib was discovered by GSK based fully commercial enterprise with multiple the most advanced of any product in on HGS technology. We will receive 10% opportunities to drive sustainable growth development that targets the TRAIL royalties on worldwide sales if darapladib is over the long term. We are fully committed apoptosis pathway, and three randomized commercialized, and we have a 20% to continuing to pursue this strategy. chemotherapy combination trials are co-promotion option in North America However, we also recognize the difficult currently underway to evaluate its potential and Europe. We believe that darapladib has economic conditions that surround us all. in the treatment of advanced multiple the potential to become an important We have taken a number of steps to myeloma, non-small cell lung cancer, and treatment for the prevention of cardiovas- strengthen our financial position.
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