BETHESDA, Md., Dec. 30, 2014 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that Health Canada has
accepted the company's New Drug Submission (NDS) for AMITIZA(R)
(lubiprostone), 24 mcg capsules, for the treatment of chronic
idiopathic constipation in adults and opioid induced constipation in
adults with chronic non-cancer pain.
"AMITIZA has been available to patients in the U.S., Japan, U.K. and
Switzerland, with over nine million prescriptions written in the US
alone and continued year over year growth in sales," said Peter
Greenleaf, Chief Executive Officer of Sucampo. "Together with our
partner Takeda, we are now focused on making AMITIZA available to
patients in new markets worldwide, and this new drug submission in
Canada is another important step in this process."
Sucampo is responsible for all regulatory interactions and for
negotiating approval of AMITIZA in Canada, and Takeda Canada Inc. will
have responsibility for product commercialization in that market.
Takeda will now be exclusively marketing AMITIZA in all global markets,
except Japan and the People's Republic of China.
About AMITIZA (lubiprostone)
AMITIZA (lubiprostone) is a prostone and is a locally acting chloride
channel activator, indicated in the United States 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 in the U.S. for irritable bowel syndrome with
constipation (IBS-C) (8 mcg twice daily) in women 18 years of age and
older.
Important Safety Information (U.S.)
-- 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, respectively) 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.
Please see the U.S. Full Prescribing Information here. For further
information on AMITIZA, please visit www.sucampo.com/products.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and
commercialization of medicines that meet major unmet medical needs of
patients worldwide. Sucampo has two marketed products - AMITIZA(R) and
RESCULA(R) - and a pipeline of drug candidates in clinical development.
A global company, Sucampo is headquartered in Bethesda, Maryland, and
has operations in Japan, Switzerland and the United Kingdom. For more
information, please visit www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline, The
Science of Innovation, is a registered/pending trademark of Sucampo AG.
AMITIZA is a registered trademark of Sucampo AG. RESCULA is a
registered trademark of R-Tech Ueno, Ltd, and has been licensed to
Sucampo AG.
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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.
CONTACT: Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
[email protected]