Sucampo Pharmaceuticals, Inc announced that its subsidiary, Sucampo Pharma, Ltd, has entered into a license and commercialization agreement with Abbott Japan Co Ltd for Sucampo's lubiprostone (trade name Amitiza) in Japan.

Lubiprostone is the only FDA-approved treatment for chronic idiopathic constipation (CIC) in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. In September 2008, Sucampo reported results from a phase 2b dose-ranging study of lubiprostone for CIC in Japanese patients. Based on these results, Sucampo plans to initiate phase-3 clinical testing of lubiprostone for CIC in Japan in the second quarter of 2009.

Ryuji Ueno, chairman and chief executive officer of Sucampo, said, "We are very excited to enter into this agreement with Abbott because of their strong international presence and infrastructure. Entering the Japanese market represents a key element of Sucampo's overall growth strategy of bringing our proprietary products to the global-market place while also continuing to develop and commercialize other prostone-based portfolio product candidates."

Under the terms of the agreement, Abbott will receive exclusive rights to commercialize lubiprostone in Japan for the treatment of chronic idiopathic constipation (CIC) and will receive the right of first refusal to any additional indications for which lubiprostone is developed in Japan. Abbott will be responsible for all commercialization expenses and efforts.

Sucampo will receive an upfront payment of $10 million and could receive additional milestone payments based on achieving specified development and commercialization goals. Sucampo will continue to lead the development of and regulatory activity for lubiprostone in Japan and will continue to be responsible for the costs of lubiprostone development. Following marketing authorization and pricing approval, Abbott will purchase finished product from Sucampo for distribution in Japan. Sucampo also will retain the right to co-promote lubiprostone in Japan.

In addition, Sucampo and Abbott have agreed to begin negotiating a license, commercialization and supply agreement with respect to other available territories.

Lubiprostone is a selective activator of type-2 chloride channels through which negatively charged chloride ions flow out of the cells lining the small intestine and into the intestinal cavity. As these negatively charged chloride ions enter the intestine, positively charged sodium ions move through spaces between the cells into the intestine to balance the negative charge of the chloride ions. As these sodium ions move into the intestine, water is also allowed to pass into the intestine through these spaces between the cells. This movement of water into the small intestine promotes fluid content, which in turn softens the stool and facilitates its movement, or motility, through the intestine.

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