Sucampo Pharmaceuticals, Inc. (SPI), a global pharmaceutical company,  and Abbott have introduced Amitiza (lubiprostone) in Japan, a prescription medicine for the treatment of chronic constipation not caused by organic diseases. Amitiza was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June.

"Millions of patients in Japan have been suffering from chronic constipation, without efficacious and well-tolerated, long-term treatment options. We are pleased to bring Amitiza's experience of six years and over six million prescriptions in the United States to the Japanese market, to benefit the healthcare providers and patients who need it," says Ryuji Ueno, Sucampo's chairman and chief executive officer.

"Chronic constipation is a medical condition affecting several million people in Japan and is one of the most common digestive condition complaints. Healthcare providers will now have a prescription option to help treat this condition more effectively and longer term, compared to currently approved over-the-counter medications," says Akihiko Honda, general manager, Abbott Japan.

Amitiza may significantly advance the treatment of chronic constipation and will be the only prescription option available in Japan for this condition. The medicine is the world's first chloride channel activator approved for therapeutic use, and has a unique mode of action that induces natural bowel movement frequency that is more in line with normal bowel habits.

Abbott will promote and distribute Amitiza in Japan under the terms of the 2009 license, commercialization and supply agreement with Sucampo.

Amitiza (lubiprostone) is a prostone, a local activator of type-2 chloride ion channels (ClC-2) in cells lining the small intestine. By increasing water secretion, lubiprostone softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic constipation. Additionally, activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function via the restoration of tight junction protein complexes in ex vivo studies of ischemic porcine intestine.

Amitiza is approved in the United States for the treatment of two constipation-related indications, and in Switzerland and the United Kingdom for one constipation-related indication.

Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc.

Under the direction of Sucampo AG (SAG), a wholly owned subsidiary of SPI which holds all of SPI's patents and intellectual property, Sucampo Pharma, Ltd. (SPL), a wholly owned subsidiary of SPI located in Japan, conducts clinical trials and seeks marketing approvals in that market for SAG's products and compounds. SPL submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza in September 2010. The application included data from a phase 3 efficacy trial in 124 Japanese patients as well as from a long-term, open-label safety trial in 209 Japanese patients who received lubiprostone for up to 48 weeks. The application also included data from previous trials conducted in the United States, Canada and Europe.

Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.