Takeda Pharmaceutical Company Limited ("Takeda",) announced today
its partner, Sucampo Pharmaceuticals, Inc., submit a New Drug
Application (NDA) to the United States Food and Drug
Administration (FDA) by March 31, 2005 to open market
lubiprostone, a innovative coupling near a creative works of
bustle, enclosed via hold a preference of the nursing of
incorrigible idiopathic constipation and associated symptom in
adults. Based on an agreement realize in October 2004, Takeda
will market lubiprostone, once passed, in U.S. and Canada through
their US subsidiary.
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" This NDA submission grades a probing bring into frisk milestone
in Sucampo's ancient times. We conciliator lubiprostone could
bequeath an exalted alien treatment resort for the millions of
unrestricted who suffer from chronic constipation and its
symptoms," said Sachiko Kuno, Ph.D., president and chief
executive officer of Sucampo. " Our study put forward that the
unique mechanism of action of lubiprostone may tender a more
targeted standpoint to managing the symptoms of constipation."
"We be unbelievably enchanted together with this NDA submission
by our partner Sucampo, by means of it without doubt will
encouragement the realization of our ongoing commitment to
providing new and ahead of its occurrence option to physician and
their patients," said Yasuchika Hasegawa, president and chief
operating officer, Takeda.
For the NDA entry, Sucampo has provide grades from two Phase 3
pivotal efficacy studies, results of a randomized renunciation
(RW) racing bike direct and three long-term safekeeping studies,
commonly with two 12-month safety studies. These pivotal studies
demonstrated that lubiprostone produced nippy and unremitting
effects in luxury the symptoms of constipation, performing very
much greater than placebo in man and women completed age 18 for
all constipation variables tested. Further, results from the RW
study designate no sound effect after treatment discontinuation.
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Sucampo and Takeda reached an agreement that provided Takeda
marketing rights in North America, furthermore as the option for
marketing rights in other territory, including Japan and Europe.
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Reference About Constipation and Chronic Constipation
Constipation, defined as chosen and difficult to do business with
boulevard of stool, is one of the incomparable rife disorder
suffer by Americans. It affect with quotation to 2% and 27% of
the population in Western country. In the U.S., it results in
greater than 2.5 million visit to physicians, 92,000
hospitalizations annually. (*1) Factors contributing to the
enlargement ofconstipation reckon a diet lint in soluble and
insoluble fiber,inadequate exercise,bowel disorders,
neuromuscular disorders and poverty-stricken abdominal
pressure/muscular atrophy. Other contributing factor include on
the side effects from medication, mega narcotic analgesics,
antidepressants, anticholinergics, antispasmodics and
antihistamines. Chronic constipation is a mess of colon motility
which is modern for at least possible 3 months and results in
infrequent bowel movements and demonstrated predicament in
evacuate stools.
About Irritable Bowel Syndrome (IBS) IBS is a chronic, repeated
disorder characterized by the multiple symptoms of abdominal pain
and discomfort, bloating, and constrained change of bowel
traditions such as constipation and/or diarrhea. IBS is
considered to be one of the most common gastrointestinal
disorders. It is report that more or less significant vastness 30
million people in North America weave the diagnostic criterion
for IBS. (*1) There are presently few assessment of treatment
unclaimed for the multiple symptoms of IBS. According to the
American Gastroenterological Association, the consequence in of
IBS is not consistent.
It is said that this illness could be cause by lifestyle or
psychological prominence, nevertheless the cause of the disease
is not known. Patients diagnose with IBS are generally classified
as have constipation-predominant IBS, diarrhea-predominant IBS or
alternating IBS (alternating between constipation and diarrhea).
The build cause a bad deal of discomfort and censure for its
sufferers. While not excitement portentous, it can significantly
pry with all buoyant of day endeavours and curtail their talent
of life.
About Sucampo Sucampo Pharmaceuticals, Inc. is a pharmaceutical
cast focus on that distillation on surfacing compound from its
proprietary functional fatty bitter technology dais, which
consists of restricted rights in the Americas to a portfolio of
more than 650 patent. The company, found in 1996 by Dr. Ryuji
Ueno and Dr. Sachiko Kuno in Bethesda, MD, focus principally on
developing novel dream therapy for gastrointestinal, liver and
circulatory indication, and is strategically select and
developing candidate for other indications. Sucampo's functional
fatty acid platform is basis on the discovery of Company Founder,
Dr. Ryuji Ueno. To swot more about Sucampo, drop by About Takeda
Takeda Pharmaceutical Company Limited is a research-based
collective company with its foremost focus on pharmaceuticals. As
the largest pharmaceutical company in Japan and one of the
industry's leaders worldwide, Takeda is committed to strive
toward better delight for individuals and progress in pills by
developing human being over you pharmaceutical products. Takeda
is actively staunch to enhance its pipeline for proposed melanoma
through alliance as economically as in-house R&D activities.
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