Sucampo Pharma Americas, LLC, a wholly owned subsidiary of Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), and its development
and commercialization partner's subsidiary Takeda Pharmaceuticals
U.S.A., Inc. (Takeda) today announced that the New Drug Application
(NDA) for the liquid formulation of AMITIZA® (lubiprostone) will
not be filed in the second half of 2014. In preliminary pre-NDA
meeting comments, the FDA informed Sucampo that it would require
additional data to characterize pharmacokinetics (PK) of the new
formulation.
Sucampo and Takeda announced topline results from a
pharmacodynamic, PK and tolerability study of a liquid formulation
of AMITIZA in adults with chronic idiopathic constipation (CIC).
The study showed directional improvement in spontaneous bowel
movement (SBM) frequency in favor of liquid AMITIZA compared to
placebo, but did not reach statistical significance. The
safety profile observed in this study was consistent with previous
clinical studies of AMITIZA. As a result of this outcome in
conjunction with the FDA feedback, Sucampo and Takeda are now
assessing next steps, which may include formulation modification.
The companies are also evaluating potential impact to the timing of
initiation of the second pivotal trial in the global, multicenter
Phase 3 program for pediatric functional constipation in children
aged 6 months to less than 6 years, as the liquid formulation would
be required for this study.
"As we have previously disclosed, our goals in developing a
liquid formulation of AMITIZA are to help meet the needs of
patients who will not take AMITIZA in its capsule form, as well as
to support our pediatric clinical program," said Peter Greenleaf,
Sucampo's Chief Executive Officer. "The FDA feedback and study
results provide useful direction as we seek to develop an
alternative formulation of AMITIZA for a wider range of patients
who may need it."
About (AMITIZA) lubiprostone
AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved
to treat Chronic Idiopathic Constipation (CIC) in adults.
"Idiopathic" means the cause of the constipation is unknown and not
due to an underlying illness or medication. AMITIZA 24 mcg twice
daily is also approved to treat constipation caused by opioids, a
type of prescription pain medicine, in adults with chronic,
noncancer pain. The effectiveness of AMITIZA has not been
established if you are taking a diphenylheptane opioid (e.g.,
methadone). AMITIZA 8 mcg capsules twice daily is approved to treat
Irritable Bowel Syndrome with Constipation (IBS-C) in women 18
years of age and older.
Sucampo and Takeda are developing a liquid formulation of
AMITIZA for patients who will not take a capsule, such as certain
pediatric and long-term care patients.
Important Safety Information
AMITIZA (lubiprostone) is not for everyone. If you know or
suspect you have a bowel blockage, do not take AMITIZA. If you are
unsure, your healthcare provider (HCP) should evaluate your
condition before starting AMITIZA. You should not take AMITIZA if
you have severe diarrhea.
Some patients taking AMITIZA may experience nausea or diarrhea.
If nausea occurs, take AMITIZA with food and water, if it becomes
severe, tell your HCP. If your diarrhea becomes severe, stop taking
AMITIZA and tell your HCP.
Within an hour of taking AMITIZA, a sensation of chest tightness
and shortness of breath may occur. These symptoms usually go away
within three hours, but may recur with repeated use. Tell your HCP
if you experience these symptoms.
The most common side effects of taking AMITIZA (24 mcg) twice
daily are nausea, diarrhea, headache, abdominal pain, abdominal
distension, and gas for patients treated for CIC; nausea and
diarrhea for patients treated for Opioid-Induced Constipation. The
most common side effects of taking AMITIZA (8 mcg) twice daily for
IBS-C are nausea, diarrhea, and abdominal pain. These are not all
the side effects associated with AMITIZA.
Tell your HCP if you are taking a diphenylheptane opioid (e.g.
methadone).
AMITIZA has not been studied in pregnant women. Based on animal
studies, AMITIZA may cause fetal harm. AMITIZA should only be used
during pregnancy if the potential benefits justify the potential
risk to the fetus. If you are pregnant or become pregnant while
being treated with AMITIZA, talk to your HCP to evaluate the risks
to the fetus. Tell your HCP if you are nursing and monitor infants
for diarrhea.
Tell your HCP if you have liver problems.
For further information, please
visit www.sucampo.com/products for complete Prescribing
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery,
development and commercialization of drugs based on ion channel
activators knows as prostones. Discovered by the company's
scientific co-founder, Ryuji Ueno, M.D., Ph.D., Ph.D., prostones
are naturally occurring fatty acid metabolites with unique
physiological activities. Sucampo has two marketed products –
AMITIZA and RESCULA® – and a pipeline of prostone-based product
candidates in clinical development. A global company, Sucampo is
headquartered in Bethesda, Maryland, and has operations in Japan,
the United Kingdom and Switzerland. For more information, please
visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are
registered trademarks 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.
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.
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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.
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.
CONTACT: Silvia Taylor
Senior Vice President, Investor Relations and
Corporate Communications
Sucampo Pharmaceuticals, Inc.
1-240-223-3718
staylor@sucampo.com
Roseanne Durril
Takeda Pharmaceuticals U.S.A., Inc.
1-224-554-1474
roseanne.durril@takeda.com
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