CAMBRIDGE, Mass., May 10 /PRNewswire/ -- Genzyme Corporation and
Peptimmune, Inc. today announced that Genzyme has granted an exclusive
worldwide license to Peptimmune to develop and market a Genzyme
investigational drug candidate for the treatment of obesity and other
metabolic disease indications. Peptimmune plans to file an IND with the U.S.
Food and Drug Administration to begin clinical trials of the drug later this
year.
Under the agreement, Genzyme grants Peptimmune exclusive rights to
develop, manufacture and commercialize GT389-255, in exchange for royalties,
in addition to shared milestones and payments if the program is partnered
further. Financial details were not disclosed.
"The acquisition of a product in the metabolic disease field that could
enter the clinic in 2004 broadens and diversifies Peptimmune's pipeline,"
stated Tom Mathers, president of Peptimmune. "It accelerates our evolution
from a research and discovery stage company, to a fully integrated
biopharmaceutical company. The prospect of a new treatment for obesity offers
hope for the millions of people suffering from this worldwide epidemic."
The investigational drug candidate, GT389-255, has a dual mechanism of
action, serving as a pancreatic lipase inhibitor and a fat-binder. It acts
within the gastro-intestinal tract to prevent fat digestion and is expected to
have fewer side-effects than currently marketed therapies. GT389-255 has been
evaluated in a number of preclinical studies, including investigational new
drug-enabling toxicology studies.
"We have discovered a very innovative treatment for obesity that has the
potential to address a very serious and growing worldwide public health
problem," stated Ted Sybertz, Ph.D., senior vice president and general manager
of Genzyme Drug Discovery and Development. "However, because of its broad
physician call-point, obesity is not a strategic fit for Genzyme. Given
Peptimmune's experienced management team, clinical development expertise in
both autoimmune and metabolic disease, and their commitment to moving this
program forward, we think they are an excellent partner."
The Genzyme drug discovery effort that developed the anti-obesity program
has drawn upon the company's extensive expertise in developing compounds to
treat metabolic disease and its world-renowned reputation in polymer
chemistry. Two polymer products have been brought to market, Renagel(R)
(sevelamer hydrochloride), a calcium-free, metal-free phosphate binder for
patients with end-stage renal disease, and WelChol(R) (colesevelum
hydrocholoride), a cholesterol-lowering agent. A third polymer, tolevamer,
has recently completed Phase 2 clinical trials for the treatment of C.
difficile associated diarrhea. These polymer therapies are not absorbed and
all act within the GI tract.
Obesity -- An Expanding Epidemic
Obesity is a global healthcare issue that is associated with an increased
risk of serious metabolic diseases, including cardiovascular disease, Type 2
diabetes, hypertension, stroke, dyslipidemia, and osteoarthritis. Published
prevalence rates indicate that more than 180 million people in the United
States and Europe are obese, and the number of obese individuals continues to
increase dramatically worldwide. A 1999 article published in the Journal of
the American Medical Association estimates that there are some 300,000 deaths
per year in the United States that are attributed to overweight and obesity.
According to data released by the U.S. Department of Health and Human
Services, the direct medical costs to the U.S. population that were attributed
to obesity totaled $117 billion in 2000.
About Genzyme
Genzyme Corporation is a global biotechnology company dedicated to making
a major positive impact on the lives of people with serious diseases. The
company's broad product portfolio is focused on rare genetic disorders, renal
disease, osteoarthritis and immune-mediated diseases, and includes an
industry-leading array of diagnostic products and services. Genzyme's
commitment to innovation continues today with research into novel approaches
to cancer, heart disease, and other areas of unmet medical need. More than
6,300 Genzyme employees in offices around the globe serve patients in over 80
countries.
About Peptimmune
Peptimmune, Inc. is a privately held biotechnology company focused on
development of therapeutics for the treatment of autoimmune and metabolic
diseases.
The company is led by an experienced management team with a track record
of building commercial biotechnology companies. Peptimmune has one product in
clinical trials for the treatment of pemphigus vulgaris, and a pipeline of
late stage preclinical products for the treatment of autoimmune and metabolic
diseases including, multiple sclerosis, rheumatoid arthritis and obesity. For
information, access our website at http://www.peptimmune.com.
This press release contains forward-looking statements, including the
statements regarding the future prospects of GT389-255, plans for the
continued development of GT389-255, including the timing of regulatory filings
and future clinical trials, whether such filings will be acceptable to
regulatory authorities and thereby enable Peptimmune to begin a Phase 1
clinical trial, the possibility that GT389-255 could be a new treatment for
obesity, the possibility that GT389-255 could have fewer side effects than
current marketed therapies, and Peptimmune's commitment to developing GT389-
255. These statements are subject to risks and uncertainties that could cause
actual results to differ materially from those projected in these forward-
looking statements. These risks and uncertainties include, among others, the
uncertainties associated with drug development including the regulatory
process in the United States and foreign countries for new drug candidates;
uncertainties in conducting clinical trials; competitive product development;
the requirement for substantial funding to conduct research and development
work and the ability of Peptimmune to provide for or obtain such funding; the
effectiveness of GT389-255 at reducing the side effects of current therapies;
whether GT389-255 will promote weight loss and whether weight loss will then
have an affect on other health issues; market acceptance of new products; the
ability to obtain and maintain patent or other proprietary intellectual
property protection and the actual impact of those patents and rights; the
accuracy of information concerning the market for such a therapy, the
competitive environment; the prevalence of obesity in the United States and
Europe; and the risks and uncertainties described in reports filed by Genzyme
with the Securities and Exchange Commission under the Securities Exchange Act
of 1934, as amended, including without limitation the information under the
heading "Factors Affecting Future Operating Results" in the Management's
Discussion and Analysis of Financial Condition and Results of Operations
section of the Genzyme Annual Report on Form 10-K for the year ending December
31, 2003. Genzyme cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. These statements
speak only as of the date of this press release, and Genzyme undertakes no
obligation to update or revise the statements.
Genzyme(R) and Renagel(R) are registered trademarks of Genzyme Corporation
and WelChol(R) is a registered trademark of Sankyo Pharma, Inc. All rights
reserved.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line at 1-800-
905-4369 within the United States or 1-703-797-1866 outside the United States.
SOURCE Peptimmune, Inc.
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Related links:
http://www.peptimmune.com
CONTACT:
Maria Foley of Genzyme, +1-617-768-6690; or
Timothy Harris of Peptimmune, +1-617-715-8009
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