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Sucampo's Amitiza(TM) is Finalist for The Scrip Award for Best New Small-Molecule Drug in 2006

Posted on: Tuesday, 19 September 2006, 15:00 CDT

BETHESDA, Md., Sept. 19 /PRNewswire/ -- Sucampo Pharmaceuticals, Inc. today announced that it is a finalist for the 2006 Scrip Award for the best new small-molecule drug category for its new drug Amitiza(TM), a selective chloride channel activator for the treatment of chronic idiopathic constipation in adults.

The other finalists for the award, which will be announced November 15 in London, are Pfizer Inc., for Chantix, and Bayer AG, for Nexavar.

Amitiza(TM) (lubiprostone), is based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. Sucampo is focused on developing prostones that have novel mechanisms of action for the treatment of gastrointestinal, respiratory, vascular and central nervous system diseases and disorders.

Amitiza(TM), approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, was developed by Sucampo Pharmaceuticals, Inc., and is jointly marketed in the United States by Sucampo and Takeda Pharmaceuticals North America, Inc. Amitiza(TM) is a selective type-2 chloride channel activator that promotes intestinal fluid secretion, thereby facilitating the passage of stool and relieving associated symptoms of constipation. In clinical studies, Amitiza(TM) increased the frequency of bowel movements and improved abdominal bloating, abdominal discomfort, stool consistency, and straining. Amitiza(TM) is the only prescription product for the treatment of chronic idiopathic constipation that has been approved by the FDA for use by adults of all ages, including those over 65 years of age, and has demonstrated effectiveness for use beyond 12 weeks.

The Scrip Awards, annual awards inaugurated in 2005, are, in the words of its sponsors, "designed to recognize the excellent work taking place throughout the pharmaceutical and biotech industries globally, and give deserved publicity to the many in pharma and biotech who routinely exceed and excel, and whose work benefits us all. With awards ranging from Best New Drug to Scientist/Team of the Year, The Scrip Awards give the chance for all in the pharmaceutical and biotech industries to shine in their particular area of expertise." The Scrip Awards were created by Informa Healthcare, a British- based provider of business information for the pharmaceutical, biotechnology, medical devices, diagnostics, instrumentation, crop protection, animal health and brewing industries.

About Amitiza(TM)

Amitiza(TM) is indicated for the treatment of chronic idiopathic constipation in the adult population in the United States. Amitiza(TM) should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating Amitiza(TM) treatment.

The safety of Amitiza(TM) in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. Amitiza(TM) 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(TM) and should be capable of complying with effective contraceptive measures.

Amitiza(TM) should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.

In clinical trials, the most common adverse event was nausea (31%). Other adverse events (>_5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).

For full prescribing information, visit http://www.amitiza.com/. Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is an emerging pharmaceutical company based in Bethesda, Md. Sucampo was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and CEO, and Ryuji Ueno, MD, Ph.D., Ph.D., the company's co-founder and Chief Scientific Officer. Sucampo focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo received marketing approval from the FDA for its first product, Amitiza(TM), for the treatment of chronic idiopathic constipation in adults. Sucampo has entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to jointly commercialize Amitiza(TM) for gastrointestinal indications in the United States and Canada. Sucampo's specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities.

Amitiza(TM) is a trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

CONTACT: Brad Fackler of Sucampo Pharmaceuticals, Inc., +1-301-961-3400

Web site: http://www.sucampo.com/http://www.amitiza.com/

Source: PRNewswire

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