Takeda and Sucampo Enter Into Global Licensing Agreement for AMITIZA(R) (lubiprostone)
Takeda Gains Exclusive Rights to AMITIZA Beyond U.S. and Canada for All Markets Except Japan and China
BETHESDA, Md., October 21, 2014 and OSAKA, Japan, October 22, 2014
(GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo)
(Nasdaq:SCMP), a global biopharmaceutical company, and Takeda
Pharmaceutical Company Limited (Takeda) today announced that on October
17, 2014, they entered into a global license, development,
commercialization and supply agreement for AMITIZA(R) (lubiprostone).
Through this agreement, Takeda expanded its exclusive rights beyond the
United States (U.S.) and Canada to further develop and commercialize
AMITIZA in all global markets, except Japan and the People's Republic
of China.
"Takeda is committed to being a patient and customer-centric
organization, making quality health products available to the patients
who need them. Through this agreement, AMITIZA can now be made
available to patients worldwide," said Shinji Honda, Senior Managing
Director and Corporate Strategy Officer. "Takeda forms partnerships to
advance science and to provide innovative treatment options for
patients, and this global agreement is an excellent example. This
global collaboration leverages the expertise we have established
through our gastroenterology portfolio of products."
"The expansion of our collaboration with Takeda represents a critical
step forward with our strategic plan and is the natural evolution of
our partnership with them for North America," said Peter Greenleaf,
Chief Executive Officer of Sucampo. "This agreement allows Sucampo to
remain focused on our strengths in drug development while allowing us
to make AMITIZA available to more patients in need around the world. We
are confident that with the combination of their extensive experience
with AMITIZA and proven global infrastructure, that Takeda will build
the brand in new global markets as they have done in the U.S., where
AMITIZA continues to grow steadily."
Under the terms of the agreement, Sucampo will receive an upfront
payment of $14 million from Takeda and will also be eligible for up to
$35 million in additional commercial milestones contingent on the
achievement of certain net sales revenue targets. Additionally, Sucampo
will be the exclusive supplier of AMITIZA to Takeda at an agreed-upon
supply price.
Takeda will be responsible for all development activities and costs,
with Sucampo assuming responsibility for the first $6 million in
development expenses. In addition, Takeda will become the marketing
authorization holder and will be responsible for all commercialization
and regulatory activities.
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
-- 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 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 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.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals).
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; the ability of Sucampo to
develop and commercialize existing and pipeline products; 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; the effects of competitive
products on Sucampo's products; 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 10-K as filed with the
Securities and Exchange Commission on March 12, 2014 as well as its
filings with the Securities and Exchange Commission on Form 10-Q and
8-K, which Sucampo incorporates by reference.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda
is committed to strive towards better health for people worldwide
through leading innovation in medicine. Additional information about
Takeda is available through its corporate website, www.takeda.com.
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 U.S. 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
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
[email protected]
Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
Tel: +81-3-3278-2037
Takeda Pharmaceuticals International, Inc.
Jocelyn Gerst
Corporate Communications Dept.
Tel: +1-224-554-5542