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 opioids cause.
"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 patients."
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 movements.
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
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
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
For further information, please visit www.sucampo.com/products
for complete Prescribing Information.
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 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.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718