FYI from Human Genome Sciences: GSK Initiates Second Pivotal Phase 3 Trial for Investigational Cardiovascular Medication Darapladib

Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated its second pivotal Phase 3 trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA₂ inhibitor darapladib in men and women with acute coronary syndrome (ACS). GSK announced the initiation of its first pivotal trial of darapladib in December 2008.

Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.

All inquiries regarding the Phase 3 study of darapladib should be directed to the contacts provided by GSK.

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.

Safe Harbor Statement

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 Human Genome Sciences’ unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, Human Genome Sciences’ 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 facilities, intense competition, the uncertainty of patent and intellectual property protection, Human Genome Sciences’ 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 SEC. 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.

Media Contact:
Jerry Parrott
Vice President, Corporate Communications
301-315-2777

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GSK Initiates Second Pivotal Phase III Trial for Investigational Cardiovascular Medication Darapladib

GlaxoSmithKline today announced initiation of the second large-scale Phase III clinical trial to evaluate long-term treatment with the investigational Lp-PLA₂ inhibitor darapladib in men and women with acute coronary syndrome (ACS). The study, called SOLID-TIMI 52 (The Stabilisation of pLaque Using darapladib -Thrombolysis In Myocardial Infarction 52), will include 11,500 patients from 40 countries.

SOLID-TIMI 52 is a randomised, placebo-controlled, double-blind trial in men and women with ACS. The study will evaluate the clinical efficacy of long-term use of darapladib as compared with placebo when both are added to standard of care (which may include a statin, aspirin and blood pressure medications). The study will test whether darapladib affects the chances of having a cardiovascular event, such as a heart attack or stroke, when treatment is started within 30 days after an acute coronary syndrome.

"Because cardiovascular disease remains the world’s number one killer, new approaches to treatment are needed. Targeting and inhibiting the Lp-PLA₂ enzyme may reduce the risk of cardiovascular events in patients with heart disease,” said Patrick Vallance, MD, Senior Vice President, Drug Discovery, GlaxoSmithKline. "With more than 27,000 patients, the combined Phase III clinical programme for darapladib will be one of the largest ever conducted to evaluate the efficacy and safety of any cardiovascular medication”.

SOLID-TIMI 52 is the second pivotal Phase III trial to evaluate darapladib. The first large-scale trial, STABILITY, is studying darapladib in patients with chronic coronary artery disease. STABILITY was initiated in late 2008 and has completed enrollment ahead of schedule with more than 15,000 patients recruited.¹

About SOLID-TIMI 52

In SOLID-TIMI 52, men and women with ACS and receiving standard of care will be randomised 1:1 to once-daily doses of darapladib 160 mg enteric-coated tablets or placebo. The study will be stopped when approximately 1500 reports of first occurrence of a major adverse coronary event (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke have occurred. This is estimated to be approximately three years, with interim independent analyses planned. It is anticipated that most subjects will be dosed for a minimum of 2 years and up to 3.5 years or more.

The secondary objectives of SOLID-TIMI 52 are to evaluate whether darapladib has an impact on the occurrence of major and total coronary events including coronary heart disease death, non-fatal heart attack, urgent and non-urgent coronary revascularisation, hospitalisation for unstable angina and all-cause mortality. Additional safety data will also be collected.

About Darapladib and Lp-PLA₂

Darapladib is a selective and orally active inhibitor of Lp-PLA₂ currently in Phase III development as a potential anti-atherosclerosis agent. Darapladib is being investigated to determine whether it can reduce the occurrence of major cardiovascular events in patients with coronary heart disease.

Lp-PLA₂ is an enzyme found in blood and atherosclerotic plaque. The underlying process in most heart attacks and strokes is atherosclerosis, which is an inflammatory disease characterised by the build-up of plaque within the walls of arteries. The rupture of unstable atherosclerotic plaque, regardless of the size of the plaque, causes most heart attacks and strokes. Elevated Lp-PLA₂ activity has been implicated in the development and progression of atherosclerosis. Large amounts of Lp-PLA₂ are present in the necrotic core of rupture-prone human coronary plaques.

About Acute Coronary Syndrome (ACS)

Acute Coronary Syndrome is a term used for any condition brought on by sudden reduced flow to the heart. It includes unstable angina (increasing unpredictable chest pain) and heart attack.² ACS may develop slowly over time by the build-up of plaques in the arteries of the heart.^3,4

Coronary artery disease is the leading cause of death globally and the single largest killer of Americans. According to the World Health Organization (WHO), 7.2 million people worldwide die each year from CAD and more than 12 million die from a heart attack or stroke.⁵

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2008.

References

1. ClinicalTrials.gov. The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY). Accessed October 6, 2009. Available at http://clinicaltrials.gov/ct2/show/NCT00799903?term=darapladib&rank=6.
2. American Heart Association. Acute Coronary Syndrome. Accessed October 6, 2009. Available at http://www.americanheart.org/presenter.jhtml?identifier=3010002.
3. National Heart, Lung and Blood Institute, Disease and Conditions Index. What is Coronary Artery Disease? Accessed October 6, 2009. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html.
4. National Heart, Lung and Blood Institute, Disease and Conditions Index. What is Atherosclerosis? Accessed October 6, 2009. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/Atherosclerosis/Atherosclerosis_WhatIs.html.
5. World Health Organization. The top 10 causes of death; updated October 2008. Accessed October 6, 2009. Available at http://www.who.int/mediacentre/factsheets/fs310/en/index.html.