Human Genome Sciences and GlaxoSmithKline Announce Publication of BLISS-52 Phase 3 Study Results for Benlysta in The Lancet

Update: Benlysta (belimumab) Now FDA Approved - March 9, 2011

ROCKVILLE, Md. & LONDON--(BUSINESS WIRE)--Feb 7, 2011 - Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced publication of the BLISS-52 study of BENLYSTA® (belimumab) in autoantibody-positive patients with active systemic lupus erythematosus (SLE) in The Lancet (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61354-2/abstract).

The BLISS-52 study, one of two pivotal Phase 3 trials, was a double-blind, placebo-controlled, multi-center superiority trial to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in autoantibody-positive patients with active SLE. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. The Phase 3 program for belimumab is the largest clinical program ever conducted in patients with SLE.

A Comment accompanying The Lancet article was authored by John H. Stone, M.D., of Massachusetts General Hospital and Harvard Medical School (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61354-2/abstract).

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. It is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006. The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of March 10, 2011.

About GlaxoSmithKline

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. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.

About Human Genome Sciences

Human Genome Sciences exists to place new therapies into the hands of those battling serious disease.

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 medinfo@hgsi.com or by calling HGS at (877) 822-8472.

HGS, Human Genome Sciences, and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

HGS 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 and regulatory approvals, 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.

GlaxoSmithKline Forward-Looking Statements

Under the safe harbor provisions of the US 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 GSK's Annual Report on Form 20-F for 2009.

 

Contact: HGS CONTACTS:
Media
Jerry Parrott, 301-315-2727
Vice President, Corporate Communications
or
Susannah Budington, 301-545-1062
Director, Corporate Public Relations
or
Investors
Claudine Prowse, Ph.D., 301-315-1785
Executive Director, Investor Relations
or
Peter Vozzo, 301-251-6003
Senior Director, Investor Relations
or
GSK CONTACTS:
U.K. Media Inquiries
David Mawdsley, (020) 8047-5502
Claire Brough, (020) 8047-5502
Stephen Rea, (020) 8047-5502
Alexandra Harrison, (020) 8047-5502
or
U.S. Media Inquiries
Mary Anne Rhyne, 919-483-2839
Jennifer Armstrong, 919-483-2839
or
European Analyst/Investor Inquiries
Sally Ferguson, (020) 8047-5543
Gary Davies, (020) 8047-5503
Ziba Shamsi, (020) 8047 3289
or
U.S. Analyst/Investor Inquiries
Tom Curry, 215-751-5419

 

 

Posted: February 2011

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