MISSISSAUGA, ON, Dec. 17, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced that its New Drug Submission ("NDS") for plecanatide for irritable bowel syndrome with constipation ("IBS-C") has been accepted by Health Canada. Cipher acquired the Canadian rights to develop, market, distribute and sell plecanatide (branded as TRULANCE® in the U.S.) from Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) ("Synergy") in February 2018. TRULANCE® is a once-daily tablet approved by the U.S. Food and Drug Administration ("FDA") for the treatment of adults with IBS-C.
It is estimated that one in four Canadians has symptoms of constipation and an estimated 38% of Canadians report constipation within the previous 12 months1. According to IMS, the total Canadian laxative and antispasmodic market (prescription and OTC) was valued at over CDN$200 million for the 12 months ended September 2017.
"This is an important milestone for the commercialization of plecanatide, an innovative new product that provides a well-tolerated and effective treatment option for the many Canadians who suffer from chronic GI disorders," said Robert Tessarolo, President and CEO of Cipher. "We continue to execute on our growth strategy and launching plecanatide in late 2019, if approved, would be a significant step in building a diversified commercial portfolio."
About Irritable Bowel Syndrome with Constipation ("IBS-C")
Irritable bowel syndrome ("IBS") is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with two or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea ("IBS-D") or mixed ("IBS-M"). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time.
TRULANCE® (plecanatide) is a once-daily tablet approved in the U.S. for adults with IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE® is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal ("GI") therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy's proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate – dolcanatide. For more information, please visit www.synergypharma.com.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs. For more information, visit www.cipherpharma.com.
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We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our Annual Information Form and in our Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2017, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
(1) "Understanding the Prevalence and Impact of Constipation in Canada": A Special Report from the Canadian Digestive Health Foundation.
SOURCE Cipher Pharmaceuticals Inc.