ROCKVILLE, Md. & BASEL, Switzerland–(Business Wire)–
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.
About Lonza
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 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.
HGS
Media
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
jerry_parrott@hgsi.com
or
Investors
Peter Vozzo
Senior Director, Investor Relations
301-251-6003
peter_vozzo@hgsi.com
or
LONZA GROUP LTD
Head Corporate Communications
Michael Frizberg
Tel +41 61 316 8624
Fax +41 61 316 9624
michael.frizberg@lonza.com
or
Media Relations
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
domink.werner@lonza.com
or
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540
Fax +41 61 316 9549
dirk.oehlers@lonza.com
Copyright Business Wire 2010