BETHESDA, Md., May 7, 2015 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator, for the prevention of oral mucositis. The FDA has also accepted the company's Investigational New Drug (IND) application to initiate a phase 2 clinical trial of cobiprostone for the prevention of oral mucositis in patients suffering with head and neck cancer receiving concurrent radiation and chemotherapy.
The FDA established the Fast Track Designation process to facilitate the development and expedite the review of drugs that have the potential to treat serious conditions and address an unmet medical need. Fast Track designated programs are afforded greater access to the FDA and may be eligible for accelerated approval and priority review, thereby expediting the FDA review process.
"Oral mucositis is a severe condition that affects patients receiving radiation and chemotherapy for the treatment of head and neck cancer, and for which there are no approved drugs in the U.S.," said Peter Greenleaf, Chief Executive Officer of Sucampo. "In the U.S., there are approximately 60,000 new patients who are diagnosed with head and neck cancer every year, and there is a significant need for new strategies to address the risk of oral mucositis associated with the treatment of the cancer. With FDA Fast Track Designation, we will be able to interact more frequently with the agency as we advance cobiprostone, which potentially will be eligible for accelerated approval and priority review. We plan to initiate a proof-of-concept, Phase 2 study for cobiprostone in oral mucositis by the end of the quarter."
About Cobiprostone
Cobiprostone is a locally acting chloride channel activator that works to stimulate and protect the mucosal barrier function. Cobiprostone is also currently being developed for the treatment of non-erosive reflux disease (NERD), a major subtype of gastroesophageal reflux disease (GERD).
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is a global biopharmaceutical company that is built on the ongoing pursuit of scientific innovation to improve the lives of patients. Sucampo has one marketed product – AMITIZA – and a pipeline including lifecycle management and clinical development programs. Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
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Sucampo Forward-Looking Statement
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; the ability of Sucampo to continue to develop the market for AMITIZA; the ability of Sucampo to develop, commercialize or license existing pipeline products or compounds or license or acquire non-prostone products or drug candidates; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the effects of competitive products on Sucampo's products; 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 most recent Form 10-K (Form 10-K) as filed with the Securities and Exchange Commission on March 9, 2015 as well as its filings with the Securities and Exchange Commission on Forms 8-K and 10-Q since the filing of the Form 10-K, all of which Sucampo incorporates by reference.