Researchers Report NT-3 May Relieve Constipating Conditions
TARRYTOWN, N.Y.--(BUSINESS WIRE)--May 18, 1999--Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN - news)
announced that researchers from the Mayo Clinic, Rochester, Minnesota, today reported that neurotrophin-3 (NT-3)
accelerated gastrointestinal and colonic transit in a clinical study of healthy volunteers and patients with constipation
and may constitute a novel approach to correcting constipating conditions. The findings of the study, which was
sponsored by Amgen-Regeneron Partners, were presented at the 100th Annual Meeting of the American
Gastroenterological Association being held in Orlando, Florida.
Regeneron is currently conducting, on behalf of Amgen-Regeneron Partners, additional small clinical studies of NT-3 in
patients with constipation related to spinal cord injury, Parkinson's disease, and other medical conditions. The
partnership expects to initiate larger, dose-finding studies later this year.
In earlier clinical studies in normal volunteers and patients with neurological disorders, NT-3 appeared to exert strong
prokinetic effects. In the study released today, Lawrence A. Szarka., M.D., Michael Camilleri, M.D., and their
colleagues at the Mayo Clinic reported that administration of NT-3 by subcutaneous injection three times per week
relieved symptoms of constipation in eight of the ten subjects studied. The researchers also found that NT-3 facilitates
the passage of food through the stomach, small intestine, and colon.
''The consistent clinical response to NT-3 in both constipated patients and healthy volunteers, in combination with the
objective evidence that it accelerates the movement of food throughout the gastrointestinal tract, suggests that NT-3
may represent a novel agent to correct dysmotility disorders in humans,'' said Dr. Camilleri, Professor of Medicine and
Physiology at the Mayo Clinic and the lead investigator for the study.
Jesse M. Cedarbaum, M.D., Vice President, Clinical Affairs, of Regeneron noted, ''Constipation is the most common
gastrointestinal complaint in the United States, accounting for more than 2.5 million physician office visits per year,
20,000 hospitalizations, and over $700 million in annual sales of prescription and non-prescription laxatives.
Constipation is characterized by reduced frequency and/or increased difficulty of passage of stool. It can be caused by
diet, gastrointestinal problems (such as irritable bowel syndrome), neurological disorders (such as spinal cord injury,
multiple sclerosis, Parkinson's disease, and stroke), metabolic and endocrine conditions (such as diabetes or thyroid
problems), or by drugs (such as opioids, antidepressants, and calcium channel blockers). In some cases the problem is
chronic but of unknown origin (chronic idiopathic constipation).''
Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, commented, ''NT-3 is known to
have an important function in neural control of the gut. The larger clinical studies that we expect to start later this year
will provide important information about the potential use of NT-3 as a drug for serious constipating conditions that
currently have no effective treatment.''
Regeneron is a leader in the application of molecular and cell biology to the search for novel human therapeutics.
Regeneron uses its expertise in growth factors and their mechanisms of action to discover and develop protein-based
and small molecule drugs. Regeneron is currently conducting a clinical trial, in collaboration with The Procter & Gamble
Company, of AXOKINE® second generation ciliary neurotrophic factor which is being developed for the treatment of
Type II diabetes in obese patients and uncomplicated obesity. Regeneron is also conducting clinical trials, in
partnership with Amgen Inc., of brain-derived neurotrophic factor (BDNF) for the treatment of amyotrophic lateral
sclerosis and of neurotrophin-3 (NT-3) for the treatment of constipation associated with spinal cord injury and other
medical conditions.
This news release discusses historical information and includes forward looking statements about Regeneron's
products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks
associated with preclinical and clinical development of drugs and biologics, determinations by regulatory and
administrative governmental authorities, competitive factors, technological developments, the availability and cost of
capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be
canceled or to terminate without any product success, and other material risks. A more complete description of these
risks can be found in Regeneron's Form 10-K for the year ended December 31, 1998, and current Form 10-Q, copies of
which should be read before making any investment decision regarding Regeneron common stock.
Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home
Page at www.regeneron.com. Fax copies of news releases can be obtained from Regeneron's News-on-Demand Service
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