| HUMAN GENOME SCIENCES REPORTS INCREASING MOMENTUM TOWARD COMMERCIALIZATION AND ANNOUNCES 2010 GOALS AT JPMORGAN HEALTHCARE CONFERENCE |
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- Marketing applications planned for BENLYSTA™ in U.S. and Europe in second quarter 2010; potential U.S. approval in fourth quarter 2010 - - Marketing applications submitted in fourth quarter 2009 for ZALBIN™/JOULFERON® in U.S. and Europe; potential U.S. approval in late 2010 - - HGS provides financial guidance: expects 2010 net cash burn of $300-350 million and year-end 2010 cash position of $840-890 million - ROCKVILLE, Maryland – January 11, 2010 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today will announce its priority goals for 2010 and report on the Company’s increasing momentum toward commercialization of late-stage products for systemic lupus and chronic hepatitis C in a presentation by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 28th Annual JPMorgan Healthcare Conference in San Francisco. “2010 will be another pivotal year for HGS,” said Mr. Watkins. “In 2009, we and our partners successfully completed Phase 3 development of BENLYSTA for systemic lupus and ZALBIN for chronic hepatitis C. In the fourth quarter of 2009, we submitted a Biologics License Application (BLA) for ZALBIN in the United States, and Novartis submitted a Marketing Authorization Application (MAA) under the brand name JOULFERON in Europe. We and GSK plan to submit marketing applications for BENLYSTA in the U.S. and Europe in the second quarter of 2010. We have the potential for regulatory approval of two major products in the U.S. before the end of this year, both directed to large and growing markets that represent significant medical need. We greatly strengthened our cash position in 2009 with two successful public offerings of common stock. Even with our expected ramp of investment in commercial build-out and pre-launch manufacturing, we expect to end 2010 with between $840 million and $890 million in cash and investments.” During his presentation, Mr. Watkins will discuss the following goals and updates on progress: LATE-STAGE PRODUCTSBENLYSTA™: First Drug for Lupus to Succeed in Phase 3 Trials; On Track for Second Quarter 2010 Submission of U.S. and European Marketing Applications; Potential U.S. Approval Fourth Quarter 2010
“Based on the Phase 3 results, BENLYSTA could become the first new approved drug in more than fifty years for people living with systemic lupus,” said Mr. Watkins. “We and GSK plan to submit marketing applications in the second quarter of 2010, following discussions with regulatory authorities in the United States and Europe.” The data showed that BENLYSTA plus standard of care achieved a clinically and statistically significant improvement in patient response rate, compared with placebo plus standard of care. BLISS study results also showed that belimumab was generally well tolerated, with rates of overall adverse events and discontinuations due to adverse events comparable between belimumab and placebo treatment groups. With nearly 1700 patients participating, the BLISS studies comprise the largest clinical trial program ever conducted in lupus. In October 2009, HGS provided a full presentation of BLISS-52 results at the Annual Scientific Meeting of the American College of Rheumatology. The BLISS-76 study was analyzed after 52 weeks in support of a potential Biologics License Application (BLA) in the United States and Marketing Authorization Applications (MAA’s) in Europe and other regions. Additional data from BLISS-76 will be available in the second quarter of 2010 following completion of the full 76-week study period. Key goals for BENLYSTA in 2010:
ZALBIN™: Phase 3 Development Successfully Completed; Marketing Applications Filed in United States and Europe; Potential Approval Second Half 2010
”Assuming licensure by regulatory agencies in the United States, Europe and other regions, HGS believes ZALBIN could become an important treatment for chronic hepatitis C,” said Mr. Watkins. “We look forward to continuing to work closely with Novartis to advance albinterferon alfa-2b to the market under the brand name ZALBIN in the United States.” The regulatory submissions include the results of two pivotal Phase 3 clinical trials, known as ACHIEVE 1 and ACHIEVE 2/3, showing that 900-mcg ZALBIN dosed every two weeks met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) dosed once each week. Patients also received oral ribavirin. In both studies, ZALBIN, with half the injections, achieved sustained virologic response comparable to that achieved by Pegasys. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2255 patients. ZALBIN will be the brand name for albinterferon alfa-2b in the United States, and 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. Key goals for ZALBIN in 2010:
Raxibacumab: $163 Million in Revenue Recognized from First 20,000 Doses Delivered to Strategic National Stockpile; Approximately $151 Million Expected from Second Order for 45,000 Doses to Be Delivered Over Three Years
Raxibacumab is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS). HGS submitted a Biologics License Application to the FDA for raxibacumab in May 2009. The BLA submission included safety and efficacy data published in the July 9, 2009, edition of The New England Journal of Medicine. The Company received a Complete Response Letter from FDA in November 2009 and discussions with FDA are planned. HGS will receive $20 million from the U.S. Government upon FDA licensure of raxibacumab. Key goals for raxibacumab in 2010:
GSK Pipeline: Two Phase 3 Trials of Darapladib Now Underway for Treatment of Cardiovascular Disease; Six Phase 3 Trials of Syncria® Ongoing for Treatment of Type 2 Diabetes Mellitus
Syncria® (albiglutide) for type 2 diabetes mellitus. In February 2009, GSK announced the initiation of a Phase 3 program to evaluate the efficacy, safety and tolerability of Syncria in the long-term treatment of type 2 diabetes mellitus. Six Phase 3 trials of Syncria are currently ongoing with the objective to demonstrate durable efficacy and cardiovascular safety of Syncria as mono- and add-on therapy. Syncria is a biological product generated from the fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood-sugar levels and to control appetite. Syncria was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million – including $33 million received to date – in addition to single-digit royalties on worldwide sales if Syncria is commercialized. ONCOLOGY PROGRAM: TRAIL PATHWAY OFFERS THERAPEUTIC OPPORTUNITIES ACROSS BROAD RANGE OF CANCERSMapatumumab (HGS-ETR1), the Company’s human monoclonal antibody to TRAIL receptor 1, is the most advanced of any product in development that targets the TRAIL apoptosis pathway. Three randomized Phase 2 chemotherapy combination trials are currently underway to evaluate mapatumumab’s potential in the treatment of advanced multiple myeloma, non-small cell lung cancer, and hepatocellular cancer. HGS is investing strategically to expand and advance its oncology portfolio around its expertise in the apoptosis, or programmed cell death, pathway. In November 2009, HGS and Aegera Therapeutics announced the initiation of a Phase 1 trial of HGS’ lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors. The study’s primary objectives include evaluation of safety and tolerability, and dose selection for Phase 2 trials. HGS1029 as monotherapy is also being studied in an ongoing Phase 1 study initiated in 2008 in patients with advanced solid tumors. The IAP inhibitors are a novel class of compounds that block the activity of IAP (inhibitor of apoptosis) proteins, allowing apoptosis to proceed and causing the cancer cells to die. When IAP proteins are over-expressed in cancer cells, they can help cancer cells resist apoptosis and resume growth and proliferation. HGS plans to continue the study of HGS1029 both alone and in combination with other anti-cancer agents, including mapatumumab. Key goals for the oncology program in 2010:
FINANCIAL GUIDANCEDuring his presentation to the JPMorgan Healthcare Conference, Mr. Watkins will present the following guidance regarding the financial results expected by HGS for the full years 2009 and 2010.
These figures do not include potential ZALBIN approval milestone payments. “From a financial perspective, 2009 was another strong year for HGS,” said Mr. Watkins. “Our financial performance substantially exceeded the guidance we provided in January 2009, both for net cash burn and year-end cash. We expect year-end 2009 cash and investments to total approximately $1.2 billion.” Presentation to Be Webcast
About Human Genome Sciences
The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA™ (belimumab) for lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. Phase 3 development has been completed successfully for both BENLYSTA and Zalbin. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the second quarter of 2010. A BLA has been submitted for ZALBIN to the FDA in the United States, and an MAA has been submitted under the brand name JOULFERON® to the EMEA in Europe. In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the Stockpile over a three-year period beginning near the end of 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of inhibitor-of-apoptosis proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. Non-GAAP Financial Measures
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