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Sucampo Pharma seeks approval for Amitiza in Switzerland
Bethesda, Maryland | Thursday, June 12, 2008, 08:00 Hrs  [IST]

Sucampo Pharmaceuticals, Inc. announced that its wholly owned subsidiary, Sucampo Pharma Europe, Ltd. (SPE), filed a Marketing Authorization Application (MAA) in Switzerland for Amitiza (lubiprostone) for the indication of chronic idiopathic constipation in adults. The MAA was filed with Swissmedic by Sucampo Pharmaceuticals' branch office in Basel, Switzerland.

The submission is part of the ongoing development of Amitiza 24 mcg which was first launched in the United States in April 2006 for the treatment of chronic idiopathic constipation in adults. In May 2008, Amitiza 8 mcg was launched for the treatment of irritable bowel syndrome with constipation in adult women. Earlier this year, MAAs were filed in nine European countries for chronic idiopathic constipation in adults at 24 mcg and are currently under review.

"Building upon the success of Amitiza in the United States, we are systematically developing additional marketing opportunities outside the United States. This application is a continuation of these efforts as well as an ongoing expansion of our European operations," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals.

In the United States, Amitiza is the only FDA-approved prescription treatment option for both chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women. Other than the United States and Canada, Sucampo Pharmaceuticals retains all commercial rights for Amitiza (lubiprostone) in Europe and the rest of the world. Amitiza (lubiprostone) was a 2006 Scrip Awards finalist for the "Best New Small-Molecule Drug" category.

Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones.

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