Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)


BETHESDA, Maryland, September 13 /PRNewswire/ --

- First Patient Enrolled in Pivotal Studies

Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals
North America, Inc. today announced that the first patient has been enrolled
in a Phase III study of lubiprostone (24 mcg, oral gel capsules, twice daily)
for the treatment of Opioid-Induced Bowel Dysfunction (OBD). The OBD Pivotal
Assessment of Lubiprostone (OPAL) program consists of two 12-week
double-blind studies, followed by a nine-month open-label safety extension
study. The double-blind studies are expected to enroll approximately 
840 patients at up to 190 sites in the United States and Canada and will 
evaluate the effects of lubiprostone as a treatment for constipation stemming 
from the use of narcotic medications, such as morphine and codeine, 
prescribed for chronic pain management.

Lubiprostone, a chloride channel activator developed by Sucampo
Pharmaceuticals, is currently approved for the treatment of Chronic
Idiopathic Constipation in adults as AMITIZA(R) (24 mcg, oral gel capsules,
twice daily) and is under FDA review for Irritable Bowel Syndrome with
constipation. AMITIZA is marketed in the United States by Sucampo
Pharmaceuticals and Takeda Pharmaceuticals North America.

"Each year, millions of patients who suffer from chronic pain are treated
with opiates," said Egilius L. H. Spierings, M.D., Ph.D, Associate Clinical
Professor of Neurology at Brigham and Women's Hospital, Harvard Medical
School. "Many of these patients frequently develop severe constipation from
these powerful analgesics; however, there are currently no approved
prescription products available to treat this condition. This study is
designed to determine whether lubiprostone can help many Americans who have
constipation as a result of taking opioid-based drugs for chronic pain."

According to the American Pain Foundation, more than 50 million Americans
suffer from chronic pain. Opioid-based pain relievers are widely prescribed
for these patients, and many of them also develop opioid-induced bowel
dysfunction.

Opioid drugs are known to increase absorption of electrolytes, including
chloride, in the small intestine, contributing to the constipating effects of
these analgesics. Lubiprostone, as a locally acting chloride channel
activator, is being studied to evaluate if it may directly counteract this
condition without interfering with the analgesic benefits of opioids. Should
lubiprostone be approved as a treatment of OBD, Sucampo Pharmaceuticals
believes it may fill an important unmet need in the market. Sucampo
Pharmaceuticals expects to file a supplemental new drug application for this
indication in mid-2009 if the results of these studies are positive.

About Opioid-Induced Bowel Dysfunction (OBD)

Opioid-Induced Bowel Dysfunction comprises a variety of gastrointestinal
conditions inclusive of severe constipation brought about by the use of
narcotic medications such as morphine and codeine, which are commonly
referred to as opioids. Physicians prescribe opioids for patients with
advanced medical illnesses as well as those undergoing surgery. Despite their
pain-relieving effectiveness, opioids are known to produce gastrointestinal
effects that lead to opioid-induced constipation, including inhibition of
large intestine motility, decreased gastric emptying and hard stools.

About AMITIZA(R) (lubiprostone) 24 mcg Twice Daily for Chronic Idiopathic
Constipation

AMITIZA (24 mcg, oral gel capsules, twice daily) is indicated for the
treatment of Chronic Idiopathic Constipation in adults. AMITIZA should not be
used in patients with a known gastrointestinal obstruction. Patients with
symptoms suggestive of mechanical gastrointestinal obstruction should be
evaluated 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 administered to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment. If the diarrhea or nausea becomes severe, patients should consult
their health professional.

In clinical trials for Chronic Idiopathic Constipation (24 mcg, oral gel
capsules, twice daily), the most common adverse reaction was nausea (29%).
Other adverse reactions (greater than or equal to 4% of patients) included
diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distension
(6%) and flatulence (6%).

For full prescribing information, visit www.amitiza.com.
    AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.



Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company based
in Bethesda, Md., focuses on the 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 CEO and
advisor, international business development. Sucampo Pharmaceuticals' first
product, AMITIZA(R), received marketing approval from the U.S. Food and Drug
Administration in January 2006 for the treatment of Chronic Idiopathic
Constipation in adults. AMITIZA is co-promoted in the United States and
Canada through an alliance between Sucampo Pharmaceuticals and Takeda
Pharmaceutical Company Limited (Osaka, Japan). Sucampo Pharmaceuticals' sales
force targets the institutional marketplace, including academic medical
centers and long-term care facilities, while Takeda focuses on office-based
specialty and primary care physicians. To learn more about Sucampo
Pharmaceuticals and its products, visit www.sucampo.com.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a
wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, the largest
pharmaceutical company in Japan. In the United States, Takeda currently
markets products for diabetes, insomnia, wakefulness and gastroenterology.
The company has a robust pipeline with compounds in development for diabetes,
cardiovascular disease and other conditions. Takeda is committed to striving
toward better health for individuals and progress in medicine by developing
superior pharmaceutical products. To learn more about the company and its
products, visit www.tpna.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 on August 22, 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.

Contact:

    Scott Solomon
    Vice President
    Sharon Merrill Associates, Inc.
    +1-617-542-5300

    David Buckalew
    Takeda Pharmaceuticals North America, Inc.
    +1-224-554-5486

    Web site: http://www.sucampo.com
              http://www.tpna.com



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