AMITIZA(R) (lubiprostone) 8 mcg Now Available to Treat Irritable Bowel Syndrome with Constipation in Adult Women

BETHESDA, Md., and DEERFIELD, Ill., May 27 -
Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals
North America, Inc. today announced that AMITIZA(R) (lubiprostone) 8 mcg
capsules are now available by prescription in pharmacies across the U.S.
for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in
women 18 years and older. AMITIZA 24 mcg capsules have been available by
prescription to treat Chronic Idiopathic Constipation in adults since 2006.

    AMITIZA is the only widely available FDA-approved prescription
treatment option that can provide overall symptom relief for the millions
of adult women in the U.S. with IBS-C.

    AMITIZA has a mechanism of action that works locally in the intestine
to increase fluid secretion, resulting in increased passage of stool and
alleviating symptoms associated with Chronic Idiopathic Constipation.
Although it is not well understood how AMITIZA works to reduce symptoms in
patients with IBS-C, ex vivo animal studies suggest that AMITIZA stimulates
recovery of mucosal barrier function by restoring tight junction protein
complexes.

    “The effects of IBS-C can be debilitating and far-reaching — affecting
many aspects of a person’s life,” said Charles Baum, M.D.,
gastroenterologist, executive medical director, Gastroenterology and
Internal Medicine, at Takeda Pharmaceuticals North America, Inc. “The
availability of AMITIZA makes it possible for appropriate patients to
receive a widely available prescription medication that can be an important
tool to help treat this condition.”

    “I am very pleased with the quick commercial launch of AMITIZA 8 mcg
for this particular indication as it could provide a treatment option to
many adult women suffering from IBS-C,” said Ryuji Ueno, M.D., Ph.D.,
Ph.D., founder, chairman and chief executive officer, Sucampo
Pharmaceuticals. AMITIZA was developed by Sucampo Pharmaceuticals and is
co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda
Pharmaceuticals North America, Inc.

    About Irritable Bowel Syndrome with Constipation (IBS-C)

    IBS is a disorder characterized by symptoms including abdominal
discomfort or pain, bloating and changes of bowel habits such as
constipation and/or diarrhea. There are three main types of IBS: IBS with
constipation (IBS-C), IBS with diarrhea (IBS-D) and IBS with mixed
constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at
least 12 weeks (not necessarily consecutive) over a 12-month period.
Although people with IBS-C report many of the symptoms associated with
constipation, the presence of abdominal discomfort or pain is what
differentiates IBS-C from chronic constipation. IBS is approximately two to
two-and-a-half times more prevalent in women than men.

    About AMITIZA(R) (lubiprostone) for Chronic Idiopathic Constipation and
IBS-C Indication

    AMITIZA(R) (lubiprostone) is indicated for the treatment of Chronic
Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome
with Constipation (8 mcg) in women 18 years and older.

    Important Safety Information

    AMITIZA is contraindicated in patients with known or suspected
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.
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. Patients who experience severe nausea should inform their
physician.

    AMITIZA should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment and inform their physician if the diarrhea becomes severe.

    Patients taking AMITIZA may experience dyspnea within an hour of first
dose. This symptom generally resolves within three hours, but may recur
with repeat dosing. Patients who experience dyspnea should inform their
physician.

    In clinical trials of AMITIZA (24 mcg) in patients with Chronic
Idiopathic Constipation, the most common adverse reactions (incidence > 4%)
were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%),
abdominal distention (6%), and flatulence (6%).

    In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel
Syndrome with Constipation, the most common adverse reactions (incidence >
4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).

    Please see complete Prescribing Information at http://www.amitiza.com.

    AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda
Pharmaceuticals North America, Inc.

    AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.

    Sucampo Pharmaceuticals, Inc.

    Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company
based in Bethesda, Md., focuses on the development and commercialization of
medicines based on prostones. The therapeutic potential of prostones, which
are bio-lipids that occur naturally in the human body, 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 is marketing AMITIZA (lubiprostone) in the U.S.
for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome
with Constipation in adult women 18 years and older, and is developing the
drug for additional gastrointestinal disorders with large potential
markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of
compounds with the potential to target underserved diseases affecting
millions of patients worldwide. Sucampo Pharmaceuticals has two wholly
owned subsidiaries: Sucampo Pharma Europe, Ltd. headquartered in Oxford,
U.K., with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd.,
located in Tokyo and Osaka, Japan. To learn more about Sucampo
Pharmaceuticals and its products, visit http://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 http://www.tpna.com.

    Media Contacts:

     Brad Fackler
     Sucampo Pharmaceuticals, Inc.
     301-961-3400 (office)

     Dave Buckalew
     Takeda Pharmaceuticals North America, Inc.
     224-554-5486 (office)

     Scott Solomon
     Sharon Merrill Associates, Inc.
     617-542-5300 (office)

     Amy Losak
     Ketchum
     646-935-3917 (office)
     917-865-6688 (cell)

SOURCE Takeda Pharmaceuticals North America, Inc.; Sucampo
Pharmaceuticals