Cipher Pharmaceuticals Acquires Exclusive Canadian Rights to FDA-Approved TRULANCE from Synergy Pharmaceuticals
MISSISSAUGA, ON, Feb. 28, 2018 /PRNewswire/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced it has acquired the exclusive Canadian rights to right to develop, market, distribute and sell TRULANCE® (plecanatide) from Synergy Pharmaceuticals. (NASDAQ:SGYP) ("Synergy"). 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."
Mr. 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 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 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.
About Irritable Bowel Syndrome with Constipation (IBS-C)
About Chronic Idiopathic Constipation (CIC)
About TRULANCE CIC and IBS-C Phase 3 Clinical Programs
About Synergy Pharmaceuticals Inc.
About Cipher Pharmaceuticals Inc.
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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