Cipher Pharmaceuticals Inc., specialty pharmaceutical company, has acquired the exclusive Canadian rights to develop, market, distribute and sell Trulance (plecanatide) from Synergy Pharmaceuticals Inc. Trulance is a once-daily tablet approved by the US 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."

Tessarolo added: "Our growth strategy is aimed at assembling a diversified portfolio of prescription medicines across a range of therapeutic areas. This agreement brings a new and differentiated GI product into our Canadian portfolio and demonstrates the continued execution of our strategy. We are targeting a New Drug Submission to Health Canada later this year and potential approval and product launch in 2019."

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.

"As an emerging leader in the Canadian healthcare industry, Cipher is an ideal partner to commercialize Trulance in Canada. Their impressive management team and track record of successfully commercializing medicines in Canada were critical decision-making factors in this collaboration," said Troy Hamilton, chief executive officer of Synergy Pharmaceuticals Inc. "This licensing agreement demonstrates our unwavering commitment to bring Trulance to as many patients and their health care providers as possible."

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), diarrhoea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 per cent of the time they defecate, and loose or watery stools less than 25 per cent of the time.

CIC affects approximately 14 per cent 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 US 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.

Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies.

Cipher is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products.