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| GLAXOSMITHKLINE EXERCISES OPTION TO HUMAN GENOME SCIENCES' TRAIL RECEPTOR ANTIBODY | |
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- Option to HGS-ETR1 exercised under a 1996 agreement - ROCKVILLE, Maryland – August 18, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that GlaxoSmithKline (NYSE: GSK) has exercised its option to develop and commercialize HGS-ETR1 (mapatumumab) jointly with Human Genome Sciences. HGS-ETR1 is a human monoclonal antibody that specifically binds to the TRAIL-receptor 1 protein, induces apoptosis in human cancer cell lines expressing TRAIL receptor 1, and has anti-tumor activity in a broad range of tumor types, both as a single agent and in combination with chemotherapy.1-13 Because HGS-ETR1 mimics the activity of the natural TRAIL-receptor 1 protein, it is considered an agonistic antibody. As part of its June 1996 agreement with GSK 14, Human Genome Sciences granted a 50/50 co-development and co-promotion option to GSK for certain Human Genome Sciences human therapeutic products that complete Phase 2a clinical trials. Under the terms of the agreement, GSK and Human Genome Sciences will share equally in Phase 3 and 4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized, under a co-development and co-promotion agreement, the remaining terms of which are being negotiated by the parties. In July 2005, Human Genome Sciences announced that GSK exercised its option to co-develop and co-commercialize LymphoStat-B™ (belimumab), which is currently in Phase 2 clinical trials in systemic lupus erythematosus and rheumatoid arthritis.15 H. Thomas Watkins, Chief Executive Officer, Human Genome Sciences, said, “We are delighted that GSK has exercised its option to develop and commercialize HGS-ETR1 jointly with Human Genome Sciences. GSK is an important strategic partner and a world leader in the pharmaceutical industry. We look forward to a productive collaboration for the development and commercialization of this novel anti-cancer agent.” Phase 2 clinical trials of HGS-ETR1 have been initiated in patients with advanced non-small cell lung cancer (NSCLC), advanced non-Hodgkin’s lymphoma (NHL) and advanced colorectal cancer.16-18 In July 2005, Human Genome Sciences reported that the NSCLC trial results showed that HGS-ETR1 was well tolerated in these patients and could be administered safely and repetitively. Stable disease was observed in 29% (9/32) of the NSCLC patients treated, with 8 patients receiving at least 4 cycles of therapy.19-20 In June 2005, the Company reported that the interim results of an ongoing Phase 2 clinical trial demonstrated that HGS-ETR1 was well tolerated, showed signs of clinical activity in NHL patients, and could safely be administered intravenously every 21 days at doses up to 10 mg/kg.2, 21 It is anticipated that the full data from the Phase 2 NHL study will be presented at an appropriate scientific meeting later in 2005. The Phase 2 trial in colorectal cancer is ongoing, with a presentation of the results anticipated on November 1 at the 2005 European Cancer Conference (ECCO). Human Genome Sciences, using genomic techniques, originally identified the TRAIL receptor-1 protein. HGS-ETR1, which targets TRAIL receptor 1, was made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.22 For more information about HGS-ETR1, see www.hgsi.com/products/ETR1.html. Health professionals interested in more information about trials involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling (240) 314-4400, extension 3550. Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. HGS, Human Genome Sciences and LymphoStat-B are trademarks of Human Genome Sciences, Inc. This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. ### Footnotes:
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