Sucampo Receives $10 Million Milestone Payment from Takeda on First Sale of
AMITIZA® (lubiprostone) for OIC in the US
AMITIZA is the World’s First and Only Oral Medication Approved for Treatment
of Opioid-Induced Constipation in Adults with Chronic, Non-cancer Pain
BETHESDA, Md. -- June 26, 2013
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) today announced that it has
received a $10 million milestone payment from Takeda Pharmaceutical Company
Limited (Takeda), pursuant to the existing collaboration and license agreement
between SPI and Takeda. The milestone payment was triggered by the commercial
launch of AMITIZA^® (lubiprostone) (24 mcg daily) in the United States 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. Some patients may discontinue opioid
therapy and thereby endure pain, rather than suffer from the constipation the
“Millions of patients in the US have been suffering from OIC, and until the
approval of AMITIZA for OIC, which received priority review status from the
FDA, there were no oral prescription products available to treat it,” said
Sucampo’s Chairman, Chief Executive Officer, and Chief Scientific Officer
Ryuji Ueno, M.D., Ph.D., Ph.D. “Opioids decrease secretion of intestinal
fluid, one of the key factors in causing OIC. As a locally acting ClC-2
channel activator, AMITIZA restores fluid secretion and can lead to relief for
those suffering from OIC. We are pleased that with this third indication for
AMITIZA, we can further our mission of meeting the unmet medical needs of
AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal
epithelium, and it bypasses the antisecretory action of opiates. AMITIZA is
the world’s first chloride channel activator approved for therapeutic use.
With more than seven million prescriptions dispensed worldwide since 2006, it
is the first and currently the only oral prescription medicine in the world
approved for OIC in adults with chronic, non-cancer pain.
In 2004, SPI and Takeda entered into a collaboration and license agreement for
AMITIZA for the United States and Canada.
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 decreases both
muscle motility and secretion of electrolytes, such as chloride, and causes
subsequent reduction in small intestinal fluid. Together, these processes
result in OIC, which is characterized by infrequent and incomplete evacuation
of stool, hard stool consistency, and straining associated with bowel
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
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
*Reduce the dosage in CIC and OIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic
For further information, please visit www.sucampo.com/products for complete
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global biopharmaceutical 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
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
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.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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