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Peptimmune obtains exclusive license from Genzyme to develop and commercialize treatment for metabolic diseases including obesity.



Genzyme Corporation (Cambridge, MA) and Peptimmune, Inc. 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 metabolic disease,
n a disorder that causes dysfunction of the metabolic action of the body, resulting in loss of control of homeostasis.

paraneoplastic syndrome 
 indications. Peptimmune plans to file an IND with the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 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 preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
, 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 (sevelamer hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid.

hy·dro·chlo·ride
n.
A compound resulting from the reaction of hydrochloric acid with an organic base.
), a calcium-free, metal-free phosphate binder for patients with end-stage renal disease End-stage renal disease (ESRD)
Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity.

Mentioned in: Chronic Kidney Failure

end-stage renal disease 
, and WelChol (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 is a global healthcare issue that is associated with an increased risk of serious metabolic diseases, including cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.

Mentioned in: Lipoproteins Test

cardiovascular disease 
, Type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
, hypertension, stroke, dyslipidemia, and osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
. 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 JAMA: The Journal of the American Medical Association is an international peer-reviewed general medical journal, published 48 times per year by the American Medical Association. JAMA is the most widely circulated medical journal in the world.  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 United States Department of Health and Human Services United States Department of Health and Human Services (USDHHS),
n.pr a cabinet-level government organization comprising 12 agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention.
, the direct medical costs to the United States population that were attributed to obesity totaled $117 billion in 2000.

Genzyme 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 Renal disease
Kidney disease.

Mentioned in: Glycogen Storage Diseases

hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg
, 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.

Peptimmune is a privately held biotechnology company focused on development of therapeutics for the treatment of autoimmune and metabolic diseases. Peptimmune has one product in clinical trials for the treatment of pemphigus vulgaris pemphigus vul·gar·is
n.
Pemphigus occurring in middle age, in which cutaneous flaccid acantholytic suprabasal bullae and oral mucosal erosions are first localized but become generalized after a few months, forming blisters that break easily and are
, and a pipeline of late stage preclinical products for the treatment of autoimmune and metabolic diseases including, multiple sclerosis, rheumatoid arthritis and obesity.

Genzyme +1-617-768-6690 www.genzyme.com

Peptimmune +1-617-715-8009 www.peptimmune.com
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Publication:BIOTECH Patent News
Geographic Code:1USA
Date:Jun 1, 2004
Words:672
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