Sucampo Pharma Ltd. (SPL), a wholly-owned Japanese subsidiary of
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), a specialty
pharmaceutical company developing prostone-based therapies for
age-related and other diseases, today announced the initiation of a
multi-center Phase 2b dose-ranging study in Japan to evaluate the
safety and efficacy of lubiprostone for adult Chronic Idiopathic
Constipation.
The randomized, parallel group, double-blind, placebo-controlled
study will compare the dose response of oral lubiprostone with that of
placebo in Japanese patients diagnosed with Chronic Idiopathic
Constipation. Approximately 160 patients are expected to be enrolled
at 13 sites. Patients will be randomized to one of three twice-daily
doses of lubiprostone (8 mcg, 16 mcg or 24 mcg capsule) or placebo.
Patients will be dosed for 14 days. The primary endpoint of the study
will be the number of spontaneous bowel movements after one week on
treatment.
"Initiation of this study is a key step in our AMITIZA(R)
commercialization strategy, which includes actively pursuing
geographical expansion in addition to the expansion of indications and
dosage formulations," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder,
chairman and chief executive officer of Sucampo Pharmaceuticals.
Said Kunihiko Soneoka, president and chief executive officer of
Sucampo Pharma, Ltd., "It is a great step forward for SPL to have an
opportunity to study the safety and efficacy of lubiprostone in
Japanese patients, who may be unsatisfied with traditional treatment
options for this condition, including lifestyle and dietary changes,
laxatives and stool softeners."
Sucampo Pharmaceuticals developed and co-markets lubiprostone (24
mcg gel capsules) in the United States as AMITIZA, the only
commercially available prescription treatment for Chronic Idiopathic
Constipation in adults. More than 750,000 AMITIZA prescriptions have
been written since the product was approved by the U.S. Food and Drug
Administration and launched in the United States in April 2006.
About Chronic Idiopathic Constipation
Constipation, one of the most common digestive complaints in the
U.S., affects up to 42 million adults, and is the cause of 2.5 million
visits to physicians and 92,000 hospitalizations annually. Based on a
retrospective analysis, it is estimated that 12 million can be
characterized as suffering from Chronic Idiopathic Constipation.
Chronic Idiopathic Constipation is chronic constipation with no known
cause. Older adults age 65 years and older are especially susceptible
to constipation.
Constipation is defined as unsatisfactory defecation that is
characterized by infrequent stools, difficult stool passage or both.
Difficult stool passage includes: straining; hard or lumpy stools;
incomplete evacuation; prolonged time to stool; or the need for manual
maneuvers to pass stool. Patients having two or more of the above
symptoms for at least six months are considered chronic.
About AMITIZA (lubiprostone) 24 mcg Twice Daily for Chronic
Idiopathic Constipation
AMITIZA(R) (lubiprostone) is indicated for the treatment of
Chronic Idiopathic Constipation in adults.
AMITIZA is contraindicated in patients with known mechanical
gastrointestinal obstruction. Patients with symptoms suggestive of
mechanical gastrointestinal obstruction should be thoroughly evaluated
by the treating physician to confirm the absence of such an
obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in
humans. In guinea pigs, lubiprostone has been shown to have the
potential to cause fetal loss. AMITIZA should be used during pregnancy
only if the benefit justifies the potential risk to the fetus. Women
who could become pregnant should have a negative pregnancy test prior
to beginning therapy with AMITIZA and should be capable of complying
with effective contraceptive measures. Patients taking AMITIZA may
experience nausea. If this occurs, concomitant administration of food
with AMITIZA may reduce symptoms of nausea.
AMITIZA should not be prescribed to patients that have severe
diarrhea. Patients should be aware of the possible occurrence of
diarrhea during treatment and be instructed to inform their physician
if the diarrhea or nausea becomes severe.
In clinical trials, the most common adverse reactions (incidence
greater than 4%) were nausea (29%), diarrhea (12%), headache (11%),
abdominal pain (8%), abdominal distention (6%), and flatulence (6%).
For full prescribing information, visit www.amitiza.com.
AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals,
Inc.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty pharmaceutical company
based in Bethesda, Md., focuses on the discovery, development and
commercialization of drugs based on prostones, a class of compounds
derived from functional fatty acids that occur naturally in the human
body. The therapeutic potential of prostones was first identified by
Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals´ chairman and
chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in
1996 with Sachiko Kuno, Ph.D., founding chief executive officer and
advisor, international business development. Sucampo Pharmaceuticals´
first product, AMITIZA(R) (lubiprostone), received marketing approval
from the FDA in January 2006 for the treatment of chronic idiopathic
constipation in adults. To learn more about Sucampo Pharmaceuticals
and its products, visit www.sucampo.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Sucampo Pharmaceuticals, Inc. are
forward-looking statements made under the provisions of The Private
Securities Litigation Reform Act of 1995. Forward-looking statements
may be identified by the words "project," "believe," "anticipate,"
"plan," "expect," "estimate," "intend," "should," "would," "could,"
"will," "may" or other similar expressions. Actual results may differ
materially from those indicated by such forward-looking statements as
a result of various important factors, including risks relating to:
the results of clinical trials with respect to Sucampo
Pharmaceuticals´ products under development; the timing and success of
submission, acceptance and approval of regulatory filings; Sucampo
Pharmaceuticals´ dependence on the commercial success of AMITIZA;
Sucampo Pharmaceuticals´ ability to obtain additional funding required
to conduct its discovery, development and commercialization programs;
Sucampo Pharmaceuticals´ dependence on its co-marketing alliance with
Takeda Pharmaceutical Company Limited; and Sucampo Pharmaceuticals´
ability to obtain, maintain and enforce patent and other intellectual
property protection for its discoveries. These and other risks are
described in greater detail in the "Risk Factors" section of Sucampo
Pharmaceuticals´ Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission for the quarter ended June 30,
2007. Any forward-looking statements in this press release represent
Sucampo Pharmaceuticals´ views only as of the date of this release and
should not be relied upon as representing its views as of any
subsequent date. Sucampo Pharmaceuticals anticipates that subsequent
events and developments will cause its views to change. However, while
Sucampo Pharmaceuticals may elect to update these forward-looking
statements publicly at some point in the future, it specifically
disclaims any obligation to do so, whether as a result of new
information, future events or otherwise.