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FDA Approves Supplemental New Drug Application for AMITIZA® (lubiprostone), the First Oral Treatment for Opioid-induced

  FDA Approves Supplemental New Drug Application for AMITIZA® (lubiprostone),
  the First Oral Treatment for Opioid-induced Constipation in Adults with
  Chronic Non-Cancer Pain

      AMITIZA Now Approved and Available for Three Separate Indications

Business Wire

BETHESDA, Md. & DEERFIELD, Ill. -- April 23, 2013

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals
U.S.A., Inc. (TPUSA) announced today that the United States (U.S.) Food and
Drug Administration (FDA) has approved Sucampo’s supplemental new drug
application (sNDA) for AMITIZA^® (lubiprostone) (24 mcg twice daily) as the
first and only oral medication for the treatment of opioid-induced
constipation (OIC) in adult patients with chronic, non-cancer pain. The
effectiveness of AMITIZA in the treatment of opioid-induced constipation in
patients taking diphenylheptane opioids (e.g., methadone) has not been
established.

This is the third indication for AMITIZA, which is also approved in the U.S.
for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg
twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult
women (8 mcg twice daily). There are more than 200 million prescriptions for
opioid use in the U.S. annually, and a substantial number of these
prescriptions are for non-cancer chronic pain. ^ Scientific literature
indicates that approximately 40-80% of patients taking opioids chronically for
non-cancer pain report constipation.

“This approval from the FDA, which received priority review status, provides
the first and only oral treatment option for opioid-induced constipation in
adult patients with chronic, non-cancer pain. As a locally acting ClC-2
channel activator, AMITIZA enhances chloride secretion together with
intestinal fluid, which is important in its role in treating OIC,” said Ryuji
Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Scientific Officer, and Chief
Executive Officer, Sucampo. “With this third indication for AMITIZA, we are
pleased to be able to provide physicians an important new option to help treat
the unmet needs of their patients.”

Opioid-based medicines are widely used in the management of chronic pain, with
OIC being a common adverse effect of chronic opioid use. Some patients may
discontinue opioid therapy and thereby endure pain rather than suffer from the
constipation the opioids cause.

“We are pleased with the FDA approval of this new indication for AMITIZA,”
said Charlie Baum, Vice President, U.S. Medical Affairs, Takeda. “It is
critical that we continue to identify and respond to the needs of physicians
and their patients with OIC.”

AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal
epithelium. AMITIZA, via activation of apical ClC-2 channels in the intestinal
epithelium, bypasses the antisecretory action of opiates.

This approval is based on results from Phase 3, well-controlled studies of 12
weeks’ duration in patients taking opioids (among them morphine, oxycodone,
and fentanyl) chronically for non-cancer pain, as well as a long-term,
open-label safety study, which provides additional support for use in this
population. Two of the Phase 3 studies met their overall efficacy endpoint,
while a third Phase 3 study did not.

About Opioid Induced Constipation (OIC)

OIC is a common adverse effect of chronic opioid use. Binding of opioids to
peripheral opioid receptors in the gastrointestinal tract results in
absorption of electrolytes, such as chloride, and subsequent reduction in
small intestinal fluid. In addition, activation of enteric opioid receptors
results in abnormal GI motility. Together, these processes result in OIC,
which is characterized by infrequent and incomplete evacuation of stool, hard
stool consistency, and straining associated with bowel movements.

About AMITIZA

AMITIZA (lubiprostone) capsules are indicated for the treatment of chronic
idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC)
in adults with chronic, non-cancer pain (24 mcg twice daily). The
effectiveness in patients with OIC taking diphenylheptane opioids (e.g.,
methadone) has not been established. AMITIZA is also indicated for irritable
bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice
daily).

Important Safety Information

  *AMITIZA (lubiprostone) 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 healthcare provider (HCP) to confirm the absence
    of such an obstruction prior to initiating AMITIZA treatment.
  *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 HCP.
  *AMITIZA should not be prescribed to patients that have severe diarrhea.
    Patients should be aware of the possible occurrence of diarrhea during
    treatment. Patients should be instructed to discontinue AMITIZA and inform
    their HCP if severe diarrhea occurs.
  *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
    HCP. Some patients have discontinued therapy because of dyspnea.
  *In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs
    N=316, respectively) in patients with CIC, the most common adverse
    reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs <1%),
    headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6%
    vs 2%), and flatulence (6% vs 2%).
  *In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=860 vs.
    N=632) in patients with OIC, the most common adverse reactions (incidence
    >4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).
  *In clinical trials of AMITIZA (8 mcg twice daily vs. placebo; N=1011 vs.
    N=435, respectively) in patients with IBS-C the most common adverse
    reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%),
    and abdominal pain (5% vs 5%).
  *Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere
    with the efficacy of AMITIZA.
  *The safety of AMITIZA in pregnancy has not been evaluated in humans. Based
    on animal data, AMITIZA may cause fetal harm. AMITIZA should be used
    during pregnancy only if the potential benefit justifies the potential
    risk to the fetus. Caution should be exercised when AMITIZA is
    administered to a nursing woman. Advise nursing women to monitor infants
    for diarrhea.

  *Reduce the dosage in CIC and OIC patients with moderate and severe hepatic
    impairment. Reduce the dosage in IBS-C patients with severe hepatic
    impairment.

For further information, please visit www.sucampo.com/products for complete
Prescribing Information.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on
innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of prostones
was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman,
Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones,
naturally occurring fatty acid metabolites that have emerged as promising
compounds with unique physiological activities, can be targeted for the
treatment of unmet or underserved medical needs. For more information, please
visit www.sucampo.com.

AMITIZA^® is a registered trademark of Sucampo AG.

Sucampo Forward-Looking Statement

This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential, future financial and
operating results, and other statements that are not historical facts. The
following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the impact of
pharmaceutical industry regulation and health care legislation; Sucampo's
ability to accurately predict future market conditions; dependence on the
effectiveness of Sucampo's patents and other protections for innovative
products; the risk of new and changing regulation and health policies in the
U.S. and internationally and the exposure to litigation and/or regulatory
actions.

No forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Sucampo undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this presentation
should be evaluated together with the many uncertainties that affect Sucampo's
business, particularly those mentioned in the risk factors and cautionary
statements in Sucampo's most recent Form 8-K and 10-K, which Sucampo
incorporates by reference.

Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development
Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.
The respective companies currently market oral diabetes, insomnia,
rheumatology, gastroenterology, and cardiovascular treatments and seek to
bring innovative products to patients through a pipeline that includes
compounds in development for metabolic and cardiovascular disease,
gastroenterology, neurology and other conditions. To learn more about these
Takeda companies, visit www.takeda.us.

Takeda Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook, strategies,
results for the future, and other statements that are not descriptions of
historical facts. Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect," "project,"
"estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro
forma," "potential," "target," "forecast," "guidance," "outlook" or "intend"
or other similar words or expressions of the negative thereof. Forward-looking
statements are based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and difficult
to predict. Investors are cautioned not to unduly rely on such forward-looking
statements.

Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements. Some of these risks and
uncertainties include, but are not limited to, (1) the economic circumstances
surrounding Takeda's business, including general economic conditions in Japan,
the United States and worldwide; (2) competitive pressures and developments;
(3) applicable laws and regulations; (4) the success or failure of product
development programs; (5) actions of regulatory authorities and the timing
thereof; (6) changes in exchange rates; (7) claims or concerns regarding the
safety or efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as
of the date of this press release, and Takeda undertakes no obligation to
revise or update any forward-looking statements to reflect new information,
future events or circumstances after the date of the forward-looking
statement. If Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make additional
updates or corrections.

Contact:

Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
staylor@sucampo.com
or
Takeda Pharmaceuticals U.S.A., Inc.
Jessica Tuquero, 1-224-554-2021
jessica.tuquero@takeda.com
or
Carrie Rose, 1-646-935-3938
Carrie.rose@ketchum.com
 
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