BenlystaTreatment for Systemic Lupus Erythematosus
Update: Benlysta (belimumab) Now FDA Approved - March 9, 2011
Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for Benlysta, a Potential New Treatment for Systemic Lupus Erythematosus
ROCKVILLE, Md. & BASEL, Switzerland--(BUSINESS WIRE)--Jul 13, 2010 - Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza today announced an agreement for the future commercial supply of Benlysta (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). Benlysta is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.
"Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of Benlysta following approval, and for the first two or three years following launch," said Randy J. Maddux, Vice President, Manufacturing Operations, HGS. "However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of highly qualified commercial manufacturing organizations, we have selected Lonza, a leader in biologics manufacturing with a global network of large-scale production sites. We are confident that Lonza is the right choice to fill this critically important role."
In June 2010, GSK submitted a Marketing Authorization Application to the European Medicines Agency, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, and HGS submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States. No new drug for lupus has been approved by regulatory authorities in more than 50 years.
"We are enthusiastic about supporting the future production of Benlysta with our cutting-edge capabilities and expertise in biopharmaceutical manufacturing," said Dr. Stephan Kutzer, Chief Operating Officer, Lonza Custom Manufacturing. "Working on such an important new drug for lupus patients will be very rewarding and the basis for a long-term, collaborative relationship with HGS."
About Benlysta (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrated that belimumab reduced autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, demonstrated that belimumab reduced SLE disease activity.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690 billion. Further information can be found at www.lonza.com.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
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 email@example.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.
Vice President, Corporate Communications
Senior Director, Investor Relations
LONZA GROUP LTD
Head Corporate Communications
Tel +41 61 316 8624
Fax +41 61 316 9624
Tel +41 61 316 8798
Fax +41 61 316 9798
Tel +41 61 316 8540
Fax +41 61 316 9549
Posted: July 2010
- FDA Approves Benlysta to Treat Lupus - March 10, 2011
- GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta PDUFA target date to 10th March 2011 - December 6, 2010
- Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus - November 17, 2010
- Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for Benlysta (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus - August 19, 2010
- Human Genome Sciences Announces Submission of Biologics License Application to FDA for Benlysta (belimumab) - June 10, 2010