Sucampo Receives $15 Million Milestone Payment from Abbott on First Sale of AMITIZA®(lubiprostone) in Japan
AMITIZA is First-ever Approved Prescription Medicine for Chronic Constipation in Japan
BETHESDA, Md. & TOKYO--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (NAS: SCMP) (SPI) today announced that its subsidiary, Sucampo AG, has received a $15 million milestone payment from Abbott's (NYS: ABT) subsidiary, Abbott Japan Co., Ltd. (Abbott), pursuant to the existing license, commercialization, and supply agreement between Sucampo Pharma Ltd. (SPL), SPI's subsidiary, and Abbott. The milestone payment was triggered by the first sale of AMITIZA® (lubiprostone) capsule 24 μg in Japan. AMITIZA is available through Abbott in Japan as a prescription medication for chronic constipation not caused by organic diseases, and was launched to primary care and specialist physicians on November 21, 2012.
"For years, millions of patients in Japan have been suffering from chronic constipation," said Sucampo's Chairman, Chief Executive Officer, and Chief Scientific Officer Ryuji Ueno, M.D., Ph.D., Ph.D. "Until the approval of AMITIZA, there had been no new chemical entity developed for chronic constipation in Japan in 32 years. Sucampo and Abbott are honored to bring AMITIZA to the Japanese market, and we look forward to the positive impact we hope this medicine will have for patients who need it."
Dr. Ueno also said the availability and first sale of AMITIZA in Japan is another step forward in the company's objective of bringing medicines with novel mechanisms of action to patients globally with unmet medical needs.
AMITIZA is the world's first chloride channel activator approved for therapeutic use, and has a unique mechanism of action to restore mucosal barrier function. With more than six million prescriptions worldwide, it is the first and currently the only prescription medicine available in Japan for chronic constipation.
In 2009, SPL and Abbott entered into a license, commercialization and supply agreement for AMITIZA in Japan.
About Chronic Constipation (excluding constipation caused by organic diseases)
Millions of people in Japan live with the pain and discomfort of chronic constipation, yet many do not seek physician care. Medical attention could mean early diagnosis and effective, long-term treatment. More than one-third of patients in Japan who seek healthcare provider care for constipation are dissatisfied with their current therapy.
AMITIZA (lubiprostone) is a prostone, a local activator of ClC-2 chloride channels in cells lining the small intestine. By increasing intestinal fluid 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.
Outside Japan, AMITIZA is approved in the United States for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older (8 mcg twice daily). AMITIZA is also approved for chronic idiopathic constipation in Switzerland and the United Kingdom.
AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.
About Sucampo Pharmaceuticals
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, Chief Scientific 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.
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 Sucampo incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
KEYWORDS: United States Asia Pacific North America Maryland Japan
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