Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today
announced that Sucampo Pharma Europe, Ltd., its wholly owned
subsidiary, has received a notice of refusal to grant a Type II
variation for AMITIZA® (lubiprostone) 24 mcg for opioid- induced
constipation (OIC) from the Medicines and Healthcare Products
Regulatory Agency (MHRA) in the United Kingdom (U.K.). In 2012, the
MHRA approved AMITIZA for the treatment of chronic idiopathic
constipation (CIC) and associated symptoms in adults when response
to diet and other non-pharmacological measures (e.g., educational
measures, physical activity) are inappropriate. In 2013, the United
States (U.S.) Food and Drug Administration approved AMITIZA as the
first and only oral medication for the treatment of OIC in adult
patients with chronic, non-cancer pain. Sucampo is reviewing the
variation assessment report (VAR) from the MHRA and intends to
explore all available options for a path forward.
Sucampo completed in 2013 a Type II variation submission to
update the Summary of Product Characteristics (SPC) for AMITIZA in
the U.K. to include the additional therapeutic indication of OIC in
non-cancer pain. MHRA is of the opinion that insufficient evidence
of efficacy for the proposed OIC indication had been
presented. The MHRA stated in the VAR that the safety profile
of lubiprostone appears consistent with what is currently described
in the SPC for the approved indication in CIC.
"While we are disappointed with the MHRA decision, we believe in
the potential of AMITIZA to meet the unmet medical needs of OIC
patients," said Peter Greenleaf, Sucampo's Chief Executive Officer.
"AMITIZA is an important treatment option for patients on three
continents, with more than 8 million patients treated in its 8
years on the market. Backed by the approval of AMITIZA for OIC
in the United States in 2013, we remain fully committed to making
AMITIZA available for additional indications in the U.K. and in
other geographic markets around the world. Sucampo intends to
work closely with the MHRA to determine our path forward."
While the MHRA application included data from the comprehensive,
global, multi-study clinical development program for AMITIZA in
OIC, which included approximately 1,300 patients across 3
placebo-controlled Phase 3 trials conducted in 7 countries
including the U.K., the MHRA considered only one of the studies to
be pivotal.
About Opioid-Induced Constipation (OIC)
OIC is a common adverse effect of chronic opioid use.
Binding of opioids to peripheral opioid receptors in the
gastrointestinal tract decreases both muscle motility and secretion
of electrolytes, such as chloride, and causes subsequent reduction
in small intestinal fluid. Together, these processes result
in OIC, which is characterized by infrequent and incomplete
evacuation of stool, hard stool consistency, and straining
associated with bowel movements.
About lubiprostone (AMITIZA)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride
channel activator, indicated in the U.S. for the treatment of CIC
(24 mcg twice daily) in adults and 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 (8 mcg twice
daily) in women 18 years of age and older. In Japan, AMITIZA
(24 mcg twice daily) is indicated for the treatment of chronic
constipation (excluding constipation caused by organic
diseases). In the U.K., AMITIZA (24 mcg twice daily) is
indicated for the treatment of CIC and associated symptoms in
adults, when response to diet and other non-pharmacological
measures (e.g., educational measures, physical activity) are
inappropriate. In Switzerland, AMITIZA (24 mcg twice daily) is
indicated for the treatment of CIC.
Important Safety Information – United
States
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 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 visit www.sucampo.com/products for complete
Prescribing Information and for further information.
Important Safety Information – United
Kingdom
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
to confirm the absence of such an obstruction prior to initiating
lubiprostone treatment.
There are no or limited data from the use of lubiprostone in
pregnant women. Patients who become pregnant or are planning a
pregnancy should be advised to consider the risks and benefits of
continued AMITIZA therapy during pregnancy.
Nausea is the most commonly reported adverse drug reaction
observed in pivotal clinical studies of AMITIZA, with 23.6% of
patients experiencing at least one treatment related nausea event;
however, of those patients, 93% reported only a single event during
treatment with AMITIZA. Of all reported nausea events, 93.7% were
mild to moderate in severity, and 4.0% discontinued treatment as a
result of nausea. Administration of AMITIZA with food has been
shown to reduce symptoms of nausea.
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 inform
their physician if severe diarrhea occurs.
Dyspnea or chest discomfort/pain (usually described as a
sensation of chest tightness and/or difficulty taking in a breath)
has been reported shortly after taking AMITIZA, and some patients
have discontinued treatment. These symptoms generally resolve
within a few hours of dosing, but recurrence has been frequently
reported with subsequent doses. If these symptoms occur, the
patient should seek medical advice before resuming treatment.
In CIC, the safety of AMITIZA has been investigated in 301
patients in 3 pivotal clinical studies. During the pivotal clinical
studies conducted on AMITIZA, a number of ADRs have been reported.
The most common ADR reported by patients taking AMITIZA was nausea,
with diarrhoea and headache also being commonly reported.
Treatment-emergent adverse events led to premature study
discontinuation for 8% of patients in the pivotal clinical
studies.
Please visit http://www.amitiza.co.uk for complete Prescribing
Information and for further information.
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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CONTACT: Silvia Taylor
Senior Vice President, Investor Relations
and Corporate Communications
1-240-223-3718
staylor@sucampo.com
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