FYI from Human Genome Sciences: GSK Initiates Darapladib Phase 3 Development Program
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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 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 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. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. 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.
GSK initiates phase III programme for novel cardiovascular medication, darapladib
Issued: Thursday 18 December 2008, London, UK
GlaxoSmithKline today announced initiation of the first pivotal Phase III clinical trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with chronic coronary heart disease (CHD). The study, called STABILITY (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) will include more than 15,000 patients from 39 countries.
"Despite major advances in medical treatment, coronary heart disease remains the leading cause of death worldwide and new approaches are needed to help reduce this burden to patients and society," said Patrick Vallance, MD., Senior Vice President, Drug Discovery, GlaxoSmithKline. "GSK is initiating the large STABILITY trial with darapladib as part of a phase III programme to determine if this novel medication could improve people's lives by reducing the risk of cardiovascular events."
STABILITY is a randomised, placebo-controlled, double-blind, parallel group multi-center, event-driven trial in men and women with chronic CHD. The study will evaluate the clinical efficacy of long-term treatment with darapladib as compared with placebo (when both are added to standard of care which may include a statin, aspirin and blood pressure medications) on the incidence of first occurrence of major adverse cardiovascular events (MACE), including CV death, non-fatal heart attack and non-fatal stroke.
"The recently completed IBIS-2 study (Integrated Biomarker and Imaging Study-2) showed that use of darapladib dramatically reduced Lp-PLA2 activity in plasma and prevented expansion of the necrotic core - a region within coronary artery plaques associated with a high risk of rupture which is the major cause of heart attacks and cardiovascular death," said Harvey White, MD, co-chair of the Steering Committee for STABILITY and director of Coronary Care and Cardiovascular Research Unit, Auckland City Hospital, Auckland, New Zealand. "STABILITY will help us to determine whether treatment with darapladib is in fact associated with favourable effects on these outcomes as well as stroke."
Coronary artery disease is the leading cause of death globally1 and the single largest killer of Americans.2 According to the World Health Organization (WHO), 7.2 million people worldwide die each year from CAD.3 Advances in science, clinical medicine, and public health over the past 50 years have resulted in significant reductions in the age-adjusted death rates from coronary heart disease and stroke, however, the clinical event rates associated with atherosclerosis have largely remained unchanged over the past 30 years. 4
About STABILITY and the Phase III programme
In STABILITY, men and women with chronic CHD and receiving standard of care will be randomised 1:1 to once-daily treatment with darapladib or placebo. The duration of the study will be determined by the rate of first occurrence of events that comprise the primary endpoint of MACE. The study will be stopped when approximately 1500 reports of first occurrence of MACE have occurred - estimated to be approximately three years - with interim independent analyses planned.
The study's secondary objectives are to evaluate the efficacy of darapladib on major and total coronary events, including CHD death, non-fatal heart attack, urgent and non-urgent coronary revascularisation, or hospitalisation for unstable angina, individual components of MACE and all-cause mortality. Additional safety and efficacy data will also be collected. Pre-specified sub-studies will include 24-hour ambulatory blood pressure monitoring, progression of protein in urine, changes in cognitive function and pharmacokinetic analyses.
GSK is also planning to initiate another large event-driven trial with darapladib in late 2009 in a post-ACS patient population. ACS represents a spectrum of clinical presentations (unstable angina, non-ST segment elevation MI, ST segment elevation MI) that are associated with an increased risk of CV death, non-fatal MI and recurrent hospital admissions for refractory myocardial ischemia.
About darapladib and Lp-PLA2
Darapladib is a selective and orally active inhibitor of LpPLA2 currently in Phase III development as a potential anti-atherosclerosis agent for the reduction of major cardiovascular events in patients with coronary heart disease. In four completed Phase II studies, 1051 patients have received darapladib for periods of up to 12 months, and 371 subjects have received darapladib 160 mg once daily for 12 weeks or longer.
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.
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.
1. WHO World Health Report, 2005.
2. Heart Disease and Stroke Statistics - 2008 Update. American Heart Association.
3. World Health Organization, Deaths from Coronary Heart Disease
4. National Heart, Lung, and Blood Institute. Morbidity and Mortality: 2007 Chart Book on Cardiovascular, Lung, and Blood Diseases. (http://www.nhlbi.nih.gov/resources/docs/07a-chtbk.pdf).
Media Contact: Jerry Parrott Vice President, Corporate Communications 301-315-2777 Investor Contact: Tim Barabe Senior Vice President and Chief Financial Officer 301-315-1780
SOURCE Human Genome Sciences, Inc.
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