Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its
wholly-owned European subsidiary, Sucampo Pharma Europe Ltd., received
notice that all of the Marketing Authorization Applications (MAA) for
lubiprostone, 24 mcg, (AMITIZA®)
for the indication of Chronic Idiopathic Constipation in adults have
been received and validated by the individual regulatory agencies in
Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain
Sweden and the United Kingdom. The applications were submitted using the
decentralized process with the United Kingdom serving as the reference
member state. With the validation, the agencies will begin their formal
review of the applications.
AMITIZA, developed by Sucampo Pharmaceuticals, is an established therapy
for Chronic Idiopathic Constipation in adults in the United States.
AMITIZA, 24 mcg, received U.S. Food and Drug Administration (FDA)
approval in January 2006 and has been available in the United States for
Chronic Idiopathic Constipation in adults since April 2006. In April
2008, AMITIZA® 8 mcg
was approved by the FDA for Irritable Bowel Syndrome with Constipation
in adult women 18 years of age and older. It is the only approved
prescription product for this indication in the United States.
"The validation of our applications and
initiation of the review process moves us one step closer to achieving
our goal of international expansion," said
Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive
officer of Sucampo Pharmaceuticals. "We will
work closely with these regulatory agencies over the coming months to
address their questions during the review and approval process."
These applications represent the first major marketing authorization
effort for Sucampo Pharmaceuticals outside the United States. Sucampo
Pharmaceuticals continues to review marketing opportunities in other
parts of the world in order to build upon the current success of AMITIZA® in the United States.
About AMITIZA® (lubiprostone)
AMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic
Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with
Constipation (8 mcg) in women 18 years of age and older.
AMITIZA 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 physician to confirm the absence of
such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans.
AMITIZA should be used during pregnancy only if the benefit justifies
the potential risk to the fetus. Women who could become pregnant should
have a negative pregnancy test prior to beginning therapy with AMITIZA
and should be capable of complying with effective contraceptive measures.
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
physician.
AMITIZA should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during
treatment and inform their physician if the diarrhea becomes severe.
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
physician.
In clinical trials of AMITIZA (24 mcg) in patients with Chronic
Idiopathic Constipation, the most common adverse reactions (incidence >
4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain
(8%), abdominal distention (6%), and flatulence (6%).
In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel
Syndrome with Constipation, the most common adverse reactions (incidence
> 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).
For full prescribing information, visit www.amitiza.com.
About Sucampo Pharma Europe, Ltd.
Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo
Pharmaceuticals, Inc., is a specialty biopharmaceutical company based in
Oxford, United Kingdom, with a branch office in Basel, Switzerland. The
European operations are focused on developing, commercializing and
marketing of AMITIZA® (lubiprostone) within Europe, the Middle East, and Africa and developing
other pipeline products based upon prostone technology. To learn more
about Sucampo Pharma Europe, Ltd., visit www.sucampoeurope.com.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company
based in Bethesda, MD, focuses on the development and commercialization
of medicines based on prostones. The therapeutic potential of prostones
which are bio-lipids that occur naturally in the human body, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals´
Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo
Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief
Executive Officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA(R) (lubiprostone) 24 mcg in
the U.S. for Chronic Idiopathic Constipation in adults and is developing
the drug for additional gastrointestinal disorders with large potential
markets. AMITIZA 8 mcg was recently approved by the FDA to treat
Irritable Bowel Syndrome with Constipation in adult women 18 years of
age and older. In addition, Sucampo Pharmaceuticals has a robust
pipeline of compounds with the potential to target underserved diseases
affecting millions of patients worldwide. Sucampo Pharmaceuticals has
two wholly-owned subsidiaries: Sucampo Pharma Europe, Ltd.
headquartered in Oxford, UK with a branch office in Basel, Switzerland
and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn
more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.
AMITIZA® is a
registered trademark of Sucampo Pharmaceuticals, Inc.
Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for Sucampo Pharmaceuticals, Inc. are forward-looking
statements made under the provisions of The Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be
identified by the words "project," "believe," "anticipate," "plan,"
"expect," "estimate," "intend," "should," "would," "could," "will,"
"may" or other similar expressions. Actual results may differ materially
from those indicated by such forward-looking statements as a result of
various important factors, including risks relating to: the results of
clinical trials with respect to Sucampo Pharmaceuticals´ products under
development; the timing and success of submission, acceptance and
approval of regulatory filings; Sucampo Pharmaceuticals´ dependence on
the commercial success of AMITIZA; Sucampo Pharmaceuticals´ ability to
obtain additional funding required to conduct its discovery, development
and commercialization programs; Sucampo Pharmaceuticals´ dependence on
its co-marketing alliance with Takeda Pharmaceutical Company Limited;
and Sucampo Pharmaceuticals´ ability to obtain, maintain and enforce
patent and other intellectual property protection for its discoveries.
These and other risks are described in greater detail in the "Risk
Factors" section of Sucampo Pharmaceuticals´ Annual Report on Form 10-K
filed with the Securities and Exchange Commission for the fiscal year
ended December 31, 2007. Any forward-looking statements in this press
release represent Sucampo Pharmaceuticals´ views only as of the date of
this release and should not be relied upon as representing its views as
of any subsequent date. Sucampo Pharmaceuticals anticipates that
subsequent events and developments will cause its views to change.
However, while Sucampo Pharmaceuticals may elect to update these
forward-looking statements publicly at some point in the future, it
specifically disclaims any obligation to do so, whether as a result of
new information, future events or otherwise.
