TOKYO, March 13 /PRNewswire/ -- Sucampo Pharma, Ltd., a subsidiary of U.S.-based Sucampo Pharmaceuticals, Inc., today announced that it has begun a repeated-dose Phase I clinical study in Japan of AMITIZA(R) (lubiprostone), Sucampo Pharmaceuticals’ U.S.-approved drug for Chronic Idiopathic Constipation in adults.
The randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability and pharmacokinetic profile of AMITIZA after repeated dosing in 12 Japanese men. Active drug subjects (n=9) will receive 24 mcg of AMITIZA twice daily for six days, with a single 24-mcg dose on the seventh day to assess the drug’s pharmacokinetics.
“Our global business strategy is designed to create multiple opportunities for AMITIZA,” said Ryuji Ueno, M.D., Ph.D., Ph.D., the Founder, Chief Executive Officer and Chief Scientific Officer of Sucampo Pharmaceuticals. “Following the successful U.S. launch of AMITIZA in 2006, Sucampo Pharmaceuticals is now ready to explore opportunities for AMITIZA outside the U.S., especially in Asia and Europe, where we have operating subsidiaries.”
About AMITIZA(R) (lubiprostone)
AMITIZA is indicated for the treatment of Chronic Idiopathic Constipation in the adult population. AMITIZA 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 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.
AMITIZA 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 (greater than or equal to 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 www.amitiza.com. AMITIZA(R) is a U.S. registered trademark of Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals is an emerging pharmaceutical company based in Bethesda, Maryland, and was founded in 1996 by Sachiko Kuno, Ph.D., the company’s President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., Ph.D., the company’s Chief Executive Officer and Chief Scientific Officer. Sucampo Pharmaceuticals 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 Pharmaceuticals received marketing approval from the U.S. Food and Drug Administration for its first product, AMITIZA, for the treatment of Chronic Idiopathic Constipation in adults. In October 2004, Sucampo Pharmaceuticals entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the U.S. and Canada. Sucampo Pharmaceuticals’ specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. Sucampo Pharmaceuticals has recently completed two pivotal Phase III clinical trials of AMITIZA for the treatment of irritable bowel syndrome with constipation (IBS-C) and expects preliminary results in Q2 2007. Phase III pivotal clinical trials of AMITIZA for the treatment of opioid-induced bowel dysfunction (OBD) are expected to commence in early to mid 2007. Sucampo Pharma, Ltd., is a wholly owned subsidiary of Sucampo Pharmaceuticals and is based in Tokyo, Japan. To learn more about the company and its products, visit www.sucampo.com.
Any statements in this press release about future expectations, plans, and prospects for Sucampo, including statements containing the words “estimates,” “believes,” “anticipates,” “plans,” “expects,” “will,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, many of which are outside of our control. In addition, the forward-looking statements included in this press release represent our views as of March 14, 2007. Subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to March 14, 2007.
Contact: Scott Solomon Vice President Sharon Merrill Associates, Inc. 617-542-5300 SSolomon@investorrelations.com
Sucampo Pharmaceuticals, Inc.
CONTACT: Scott Solomon, Vice President of Sharon Merrill Associates, Inc.,+1-617-542-5300, or SSolomon@investorrelations.com, for SucampoPharmaceuticals, Inc.
