Attached is a press release issued earlier today by GlaxoSmithKline, announcing that data have been received from the Phase 3 Harmony 8 study and from the event-driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical program in type 2 diabetes. These data are the final elements required to complete the clinical registration package. Albiglutide, an investigational once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, was created by HGS using its proprietary albumin-fusion technology, and was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million – including $33.0 million received to date – in addition to single-digit net royalties on worldwide sales if albiglutide is commercialized. All inquiries regarding the albiglutide Phase 3 data announced today should be directed to the contacts provided by GSK. Human Genome Sciences exists to place new therapies into the hands of those battling serious disease. For more information about HGS, please direct inquiries to the HGS contacts provided, or visit the Company’s web site at www.hgsi.com. HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners. SAFE HARBOR STATEMENT This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include those regarding our expectations for albiglutide, among others. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this announcement, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
Some important factors that could cause our actual results to differ from our expectations in these forward-looking statements include: our lack of commercial experience and dependence on the sales growth of BENLYSTA; any failure to commercialize BENLYSTA successfully; the occurrence of adverse safety events with our products; changes in the availability of reimbursement for BENLYSTA; the inherent uncertainty of the timing, success of, and expense associated with research, development, regulatory approval and commercialization of our pipeline products, including darapladib and albiglutide, and new indications for existing products; uncertainty as to the future success of darapladib and GSK’s ability to develop and commercialize darapladib; substantial competition in our industry, including from branded and generic products; the highly regulated nature of our business; uncertainty regarding our intellectual property rights and those of others; the ability to manufacture at appropriate scale, and in compliance with regulatory requirements, to meet market demand for our products; our substantial indebtedness and lease obligations; our dependence on collaborations over which we may not always have full control; foreign exchange rate valuations and fluctuations; the impact of our acquisitions and strategic transactions; changes in the health care industry in the U.S. and other countries, including government laws and regulations relating to sales and promotion, reimbursement and pricing generally; significant litigation adverse to the Company, including product liability and patent infringement claims; our ability to attract and retain key personnel; and increased scrutiny of the health care industry by government agencies and state attorneys general resulting in investigations and prosecutions.The foregoing list sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.