and Drug Administration Grants Priority Review Status to AMITIZA®
(lubiprostone) Submission Seeking Approval for Treatment of
BETHESDA, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)--September 25,
2012--Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda
Pharmaceuticals U.S.A., Inc. (TPUSA) today announced that the U.S. Food
and Drug Administration (FDA) has granted priority review of their
supplemental new drug application (sNDA) filing. The sNDA was filed in
late July seeking approval for an additional indication for AMITIZA®
(lubiprostone) for the treatment of opioid-induced constipation (OIC) in
patients with chronic, non-cancer pain.
The FDA’s priority review, which allows for an abbreviated review period
of six months, is granted to drugs that offer either significant
advances in treatment or provide a treatment where there is no existing
adequate therapy. As a result of this priority review, Sucampo and
Takeda expect the FDA’s decision by late January 2013.
“One of the most common adverse reactions of opioid medications is
opioid-induced constipation, a medical condition for which there are
currently no approved oral prescription treatment options available,”
said Dr. Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Scientific
Officer, and Chief Executive Officer. “The priority review of this sNDA
application underscores that the management of OIC is an unmet need of
patients with chronic pain and highlights the need for new therapies to
address this condition.”
AMITIZA (lubiprostone) is a chloride channel activator indicated for the
treatment of chronic idiopathic constipation (CIC) (24 mcg twice daily)
in adults and for irritable bowel syndrome with constipation (8 mcg
twice daily) in women 18 years of age and older by the FDA in the United
States. AMITIZA (lubiprostone) is approved in Japan for the treatment of
chronic constipation (excluding constipation caused by organic
diseases); in Switzerland for CIC; and in the United Kingdom for CIC.
Important Safety Information
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 healthcare provider 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
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 healthcare provider if the diarrhea becomes
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
healthcare provider. Some patients have discontinued therapy because of
In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=1113
vs. N=316) in patients with Chronic Idiopathic Constipation (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 (8 mcg twice daily vs. placebo; N=1011 vs.
N=435) in patients with Irritable Bowel Syndrome with Constipation
(IBS-C), the most common adverse reactions (incidence > 4%) were nausea
(8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Reduce the dosage in CIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused
on innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of
prostones, which occur naturally in the human body as a result of
enzymatic (15-PGDH) transformation of certain fatty acids, 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. For more information, please visit www.sucampo.com.
AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.
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
Form 10-K for the year ended Dec. 31, 2011, which the Company
incorporates by reference.
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research &
Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. The respective companies currently market oral diabetes,
insomnia, rheumatology, gastroenterology, and cardiovascular treatments
and seek to bring innovative products to patients through a pipeline
that includes compounds in development for metabolic and cardiovascular
disease, gastroenterology, neurology and other conditions. To learn more
about these Takeda companies, visit www.takeda.us.
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 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 United States 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.
Sucampo Pharmaceuticals, Inc.
Kate de Santis,
Pharmaceuticals U.S.A., Inc.
Jocelyn Gerst, 1-224-554-5542