|[April 18, 2012]
Sucampo and Clinigen Announce Named Patient Program for European Union, Iceland and Norway to Provide Access to AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation Patients
BETHESDA, Md. & BURTON-ON (News - Alert)-TRENT, U.K. --(Business Wire)--
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its
wholly-owned subsidiary, Sucampo AG, has implemented a Named Patient
Program (NPP) to permit access to AMITIZA (lubiprostone) for patients
with chronic idiopathic constipation (CIC) in the European Union (EU),
Iceland and Norway. Clinigen Global Access Programs (GAP) will manage
the program and will allow healthcare professionals to prescribe
lubiprostone for their patients until the time that it is approved
within their countries.
Under an NPP, physicians can prescribe unlicensed products to qualifying
patients on an individual basis. Such products can be administered to
individual patients who are suffering from serious illnesses and have no
other therapeutic options.
David Dodds, Commercial Affairs, Europe, said, "Named patient programs
are designed to assist patients who have no other alternative
therapeutic options. They are in need of access to therapies that are
either approved in other parts of the world or have shown promise in
clinical studies, prior to regulatory authority approval. Sucampo's
mission is to provide patients with safe and effective drugs with novel
mechanisms of action to the patients with unmet medical needs.
Implementing this program with Clinigen GAP assists Sucampo in
fulfilling that mission and meeting important business objectives."
Mark Corbett, Vice President Clinigen GAP commented, "We are delighted
that Sucampo has selected Clinigen GAP to manage a Named Patient Program
to provide access to lubiprostone for patients with no therapeutic
alternative. Our team has extensive global experience in developing
innovative, flexible and effective Named Patient Programs that meet the
necessary regulatory requirements for each individual territory and
address the needs of patients, health professionals and
biopharmaceutical companies. We look forward to working with Sucampo."
Lubiprostone is a local activator of ClC-2 chloride channels in cells
lining the small intestine. Lubiprostone increases fluid secretion into
the intestinal tract. This increased fluid level softens the stool,
facilitating intestinal motility and bowel movements. Type 2 chloride
channels also play an important role in the restoration of tight
junction complexes and in the recovery of barrier function in the body.
Lubiprostone is not yet licensed in the EU, Iceland or Norway.
About Chronic Idiopathic Constipation (CIC)
Constipation is characterized by infrequent and difficult passage of
stool and becomes chronic when a person suffers specified symptoms for
over 12 non-consecutive weeks within a 12 month period. Chronic
constipation is idiopathic if it is not caused by other diseases or by
the use of medications. Symptoms of CIC include straining, hard stools,
bloating and abdominal pain or discomfort.
Important Safety Information
Lubiprostone is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction. Patients with symptoms
suggestive of mechanicl gastrointestinal obstruction should be
thoroughly evaluated by the treating healthcare provider to confirm the
absence of such an obstruction prior to initiating lubiprostone
The safety of lubiprostone in pregnancy has not been evaluated in
humans. Lubiprostone 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 lubiprostone and should be capable of complying with
effective contraceptive measures.
Patients taking lubiprostone may experience nausea. If this occurs,
concomitant administration of food with lubiprostone may reduce symptoms
of nausea. Patients who experience severe nausea should inform their
Lubiprostone 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 severe.
Patients taking lubiprostone 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 dyspnea.
In clinical trials of lubiprostone (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%
In clinical trials of lubiprostone (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%
Reduce the dosage in CIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic
Sucampo AG, based in Zug, Switzerland, is a wholly-owned subsidiary of
Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc., an
international pharmaceutical company is focused on the 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 enzymic (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 and currently Advisor,
International Business Development, and a member of the Board of
Directors. For more information, please visit www.sucampo.com.
Sucampo Forward-Looking Statements
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 US 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.
Clinigen is a fast-growing global specialty global pharmaceutical
products and services business dedicated to serving patients, the
medical community and the healthcare industry. Clinigen's Global Access
Programs Division (GAP) specializes in the consultancy, development,
management and implementation of Global Access Programs for
biotechnology and pharmaceutical companies.
Clinigen's innovative, bespoke programs provide a fully outsourced
solution for managing access to unlicensed, licensed or end of lifecycle
products. Clinigen understand the value of products to a company and the
importance of protecting and maximizing the long-term value of assets
through Global Access Programs. Clinigen's highly dedicated,
multilingual and experienced team effectively manages client and product
needs. Clinigen GAP have proven management experience of implementing
over 30 programs, providing access for thousands of patients globally.
For more information, please visit www.clinigengroup.com
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