Sucampo Announces Extension of AMITIZA(R) (lubiprostone) License and Collaboration Agreement With Takeda
BETHESDA, Md., Oct. 14, 2014 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global
biopharmaceutical company, today announced that it signed on October 9,
2014 an amendment to the existing collaboration and license agreement
(Collaboration Agreement) covering the United States (U.S.) and Canada
for AMITIZA(R) (lubiprostone) with Takeda Pharmaceutical Company Ltd.
(Takeda). The amendment includes various modifications to the
Collaboration Agreement including the extension of the current term,
minimum commercial investment during the current term and various
governance changes allowing Takeda additional flexibility in
commercializing AMITIZA.
During the extended term, which will begin on January 1, 2021, Takeda
will split with Sucampo the gross profits of branded AMITIZA for any
dosage strength and form for the existing indications in the U.S. and
Canada. In addition, on April 1, 2015 Takeda will no longer reimburse
Sucampo for the product details made by Sucampo sales representatives
to healthcare professionals as well as other ancillary costs of the
sales force.
"Today's announcement of the extended collaboration with Takeda is yet
another step toward achieving our objective of securing Sucampo's
foundation and expanding the AMITIZA business. This extended
collaboration also allows Sucampo to share in the long-term value of
AMITIZA," said Peter Greenleaf, Chief Executive Officer of Sucampo.
"Takeda and Sucampo are aligned in our objectives for the brand, and I
believe this newly extended collaboration and license agreement
positions the companies more strongly than ever to help grow the
AMITIZA business."
About AMITIZA (lubiprostone)
AMITIZA (lubiprostone) is a prostone and is a locally acting chloride
channel activator, indicated in the U.S. 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
-- 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 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 product candidates in clinical
development. A global company, Sucampo is headquartered in Bethesda,
Maryland, and has operations in Japan, Switzerland and the U.K. For
more information, please visit www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline, The
Science of Innovation, is a 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]