Cipher Pharmaceuticals has acquired the exclusive Canadian rights to right to develop, market, distribute and sell TRULANCE (plecanatide) from Synergy Pharmaceuticals. TRULANCE is a once-daily tablet approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with chronic idiopathic constipation ("CIC") and irritable bowel syndrome with constipation (IBS-C).
"We are excited at the prospect of bringing an innovative new product to market that would be a safe and effective treatment option for the many Canadians who suffer from these chronic GI disorders," said Robert Tessarolo, President and CEO of Cipher. "TRULANCE has established a strong and remarkably consistent efficacy and safety profile in clinical trials with more than 4,700 CIC and IBS-C patients."
It is estimated that one in four Canadians has symptoms of constipation and an estimated 38% of Canadians report constipation within the previous 12 months. According to IMS, the total Canadian laxative and antispasmodic market (prescription and OTC) was valued at over CDN$200 million for the 12 months ending September 2017.
Under the terms of the licensing agreement, Synergy will receive an upfront payment of US$5.0 million and is eligible for an additional milestone payment, as well as royalties from product sales in Canada. The agreement provides that Synergy will be responsible for manufacturing and supplying finished product to Cipher.
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.
CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual's quality of life, including increasing stress levels and anxiety.
The efficacy and safety of TRULANCE for the treatment of CIC and IBS-C was established in four 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies involving over 4,700 patients. TRULANCE demonstrated improvement in FDA endpoints assessing abdominal pain, constipation, stool consistency and straining with bowel movements associated with IBS-C, as well as in the constipation, stool consistency and straining with bowel movements associated with CIC. These patient-reported symptoms returned within one week following discontinuation of TRULANCE. The most common adverse event in both CIC and IBS-C studies was diarrhea (≤5.0% vs. 1.0% placebo).
TRULANCE (plecanatide) is a once-daily tablet approved in the U.S. for adults with CIC or 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.