Sucampo and Takeda Launch Direct-to-Consumer Advertising Campaign for AMITIZA(R) (lubiprostone) for Chronic Idiopathic Constipation
BETHESDA, Md., Sept. 29, 2014 (GLOBE NEWSWIRE) -- Sucampo
Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) and its development and
commercialization partner, Takeda Pharmaceuticals (Takeda), today
announced the launch of a pilot direct-to-consumer advertising campaign
in select U.S. markets for AMITIZA(R) (lubiprostone) for adults with
chronic idiopathic constipation (CIC). The campaign will consist of a
60-second television spot that will air in programming including Good
Morning America, Headline News Network, and the Oprah Winfrey Network,
and a print advertisement that will run in outlets including USA
Weekend, Good Housekeeping, and Woman's Day.
"As I stated during Sucampo's second quarter earnings call, continuing
to drive revenue growth for AMITIZA is a top imperative for the
company," stated Peter Greenleaf, Chief Executive Officer of Sucampo.
"Additionally, the launch of this patient-focused campaign is critical
to educating patients and physicians about AMITIZA, and is one we hope
will increase dialogue about options to treat CIC, a condition for
which many patients remain untreated. We are pleased to be working
closely with our partner Takeda on this campaign and other ways to
maximize the value of AMITIZA in the U.S."
Both the television and print advertisements are intended to encourage
patients to talk to their doctors about CIC and AMITIZA and to direct
patients to visit www.amitiza.com or call 888-9-AMITIZA to obtain
About AMITIZA (lubiprostone)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel
activator, indicated in the United States for the treatment of 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 IBS-C (8 mcg
twice daily) in women 18 years of age and older in the U.S.
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) 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
-- Reduce the dosage in CIC and OIC patients with moderate and severe
hepatic impairment. Reduce the dosage in IBS-C patients with severe
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 to meet the 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.
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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.
Senior Vice President,
Investor Relations and Corporate Communications