Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Abbott (NYSE: ABT) today announced the availability of 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, M.D., Ph.D., Ph.D., 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.
About Chronic Constipation (excluding constipation caused by organic diseases)
According to MHLW epidemiology data, millions of people in Japan may live daily with the pain and discomfort of chronic constipation, yet not seek physician care. Medical attention could mean early diagnosis and effective, long-term treatment.
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.
About the AMITIZA Development Program in Japan
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.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com.
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. The company employs approximately 91,000 people and markets its products in more than 130 countries.
In Japan, Abbott employees are devoted to the manufacture, development, distribution, and marketing of pharmaceuticals and medical products, including nutrition, devices, diagnostics, and products for vision care. Abbott's main offices in Japan are located in Tokyo, Fukui, and Chiba. News releases issued by Abbott Japan and Abbott Headquarters are available at www.abbott.co.jp and www.abbott.com, respectively.
Sucampo Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo’s ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo’s business, particularly those mentioned in the risk factors and cautionary statements in Sucampo’s Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.