Sucampo Pharmaceuticals Obtains FDA Approval for AMITIZA® for the Treatment of Irritable Bowel Syndrome with Constipation in Adult Women
Sucampo Pharmaceuticals, Inc., (NASDAQ: SCMP, Sucampo Pharmaceuticals)
and Takeda Pharmaceutical Company Limited (TSE: 4502, Takeda) and its
wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc.
today announced that the U.S. Food and Drug Administration (FDA) has
approved Sucampo Pharmaceuticals´ supplemental
New Drug Application (sNDA) for AMITIZA® (lubiprostone) 8 mcg capsules twice daily to treat irritable bowel
syndrome with constipation (IBS-C) in women 18 years of age or older. As
a result of this sNDA approval, Sucampo Pharmaceuticals will receive a
development milestone payment of $50 million from Takeda in accordance
with the Collaboration and License Agreement dated on October 29, 2004
between Sucampo Pharmaceuticals and Takeda to jointly market AMITIZA in
the United States and Canada.
AMITIZA, developed by Sucampo Pharmaceuticals, is an established therapy
for Chronic Idiopathic Constipation in adults. It received FDA approval
in January 2006 and has been available for that indication in the United
States since April 2006. The product is co-marketed in the United States
by Sucampo Pharmaceuticals and Takeda through Takeda Pharmaceuticals
North America, Inc.
"Sucampo Pharmaceuticals is very pleased to
have the FDA approval for the IBS-C indication for AMITIZA within the
10-month PDUFA date," said Ryuji Ueno, M.D.
Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo
Pharmaceuticals. "Currently, AMITIZA is the
only widely available prescription drug therapy to treat Chronic
Idiopathic Constipation in adults. The approval of IBS-C as an
additional indication for adult women validates our commitment to the
continued development of AMITIZA for further indications and dedication
to patients and physicians in bringing forth effective drugs to serve
unmet medical needs. Sucampo Pharmaceuticals and Takeda will begin
promotion for this indication at Digestive Disease Week 2008, the
largest gathering of gastroenterologists, to raise awareness regarding
IBS-C and the ability of AMITIZA to treat this condition."
"AMITIZA´s approval
for the IBS-C indication obtained by Sucampo Pharmaceuticals is
important for Takeda since gastroenterology is one of the core
therapeutic areas for our company," said
Yasuchika Hasegawa, president of Takeda. "This
additional indication for AMITIZA will help Takeda further enhance our
position in the U.S. primary care and GI specialty markets."
"Through this approval, we are pleased to be
able to offer a medication that can provide overall symptom relief for
the millions of adult women in the U.S. with IBS-C," said Art Rice, general manager, Gastroenterology, of Takeda
Pharmaceuticals North America, Inc. "We are
prepared to rapidly roll out our extensive efforts together with Sucampo
Pharmaceuticals to educate both physicians and adult women with IBS-C to
help them understand the condition and how it may be treated with
AMITIZA."
The sNDA was based on a clinical study program that included two Phase
III, multi-center, double-blinded, randomized, placebo-controlled trials
involving 1,154 adults, followed by one long-term, open-labeled
extension trial involving 476 adults diagnosed with IBS-C. In the two
Phase III studies, patients received AMITIZA 8 mcg or placebo taken
twice daily over a 12-week period. In both trials, patients receiving
AMITIZA 8 mcg twice daily were nearly twice as likely to achieve an
overall response that was statistically significant compared to those
receiving placebo. The safety profile of AMITIZA was established during
the double-blinded period, and further confirmed by an open-labeled
extension period with a total treatment period of up to 52 weeks.
In the pivotal three-month trials, AMITIZA and placebo groups showed a
similar incidence of serious adverse events (one percent in both the
AMITIZA and placebo groups) and related adverse events (22 percent in
AMITIZA vs. 21 percent in the placebo group). The most common
treatment-related adverse events (>4
percent of patients) were nausea (8 percent in the AMITIZA group vs. 4
percent in the placebo group), diarrhea (7 percent vs. 4 percent
respectively) and abdominal pain (5 percent vs. 5 percent, respectively).
Sucampo Pharmaceuticals is currently conducting additional trials with
AMITIZA, including a clinical study for treatment of constipation in
pediatric patients; a clinical study of AMITIZA in patients with hepatic
impairment, and a full clinical development for the treatment of
opioid-induced bowel dysfunction, with two pivotal Phase III efficacy
and safety studies and one long-term safety study ongoing.
Important Safety Information about AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel
Syndrome with Constipation
AMITIZA® (lubiprostone) is indicated for the
treatment of Chronic Idiopathic Constipation in adults and Irritable
Bowel Syndrome with Constipation (IBS-C) in women ≥18 years old.
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. In
guinea pigs, lubiprostone has been shown to have the potential to cause
fetal loss. 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 3 hours, but may recur with
repeat dosing.
In clinical trials of patients with Chronic Idiopathic Constipation, the
most common adverse reactions (incidence > 4%) for Chronic Idiopathic Constipation were nausea (29%), diarrhea
(12%), headache (11%), abdominal pain (8%), abdominal distention (6%)
and flatulence (6%).
In clinical trials of patients with IBS-C, the most common adverse
reactions (incidence > 4%) were nausea
(8%), diarrhea (7%) and abdominal pain (5%).
For full prescribing information, visit www.amitiza.com.
AMITIZA® is a
registered trademark of Sucampo Pharmaceuticals, Inc.
About Irritable Bowel Syndrome with Constipation
Irritable Bowel Syndrome with Constipation (IBS-C) is a disorder
characterized by symptoms including abdominal pain or discomfort
bloating, and changes of bowel habits such as constipation and/or
diarrhea. There are three main types of IBS: IBS with constipation
(IBS-C), IBS with diarrhea (IBS-D), and IBS mixed with both constipation
and diarrhea (IBS-M). Approximately 58 million Americans have IBS, with
IBS-C accounting for approximately one-third of these cases. In IBS-C
symptoms are present for at least three months with symptom onset at
least six months prior to diagnosis. Although people with IBS-C report
many of the symptoms associated with constipation, the presence of
abdominal pain or discomfort is what mainly differentiates IBS-C from
chronic constipation. Additionally, the hypersensitivity of the
gastrointestinal system of individuals with IBS-C makes them prone to
experience the effects of even mild symptoms of constipation. IBS is
more prevalent in women than men.
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 (lubiprostone) in the U.S.
for chronic idiopathic constipation in adults and is developing the drug
for additional gastrointestinal disorders with large potential markets.
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.
Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to striving toward better health for individuals and progress
in medicine by developing superior pharmaceutical products. Additional
information about Takeda is available through its corporate website, http://www.takeda.com.
Takeda Pharmaceuticals North America, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. In
the United States, TPNA currently markets products for diabetes
insomnia, wakefulness and gastroenterology. The company has a robust
pipeline with compounds in development for diabetes, cardiovascular
disease and other conditions. To learn more about the company and its
products, visit www.tpna.com.
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 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.