Cipher Pharmaceuticals Announces PLECANATIDE Accepted for Review by Health Canada
MISSISSAUGA, ON /CNW/ - Cipher Pharmaceuticals (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.
This press release includes forward-looking statements within the meaning of certain securities laws, including the "safe harbour" provisions of the Securities Act (Ontario) and other provincial securities law in Canada and U.S. securities laws. These forward-looking statements include, among others, statements with respect to our objectives, goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. Forward-looking statements in this press release include statements with respect to the anticiapated commercial launch of Trulance in late 2019, subject to the receipt of requisite regulatory approvals. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements.
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(1) "Understanding the Prevalence and Impact of Constipation in Canada": A Special Report from the Canadian Digestive Health Foundation.
SOURCE Cipher Pharmaceuticals Inc.
Company Codes: OtherOTC:CPHRF, Toronto:CPH, OTC-PINK:CPHRF