Knight Therapeutics Inc.
TSX : GUD

Knight Therapeutics Inc.

March 19, 2018 06:30 ET

Knight Announces Exclusive License Agreement with Ardelyx for Tenapanor

Agreement Advances First-in-Class Tenapanor for IBS-C and Hyperphosphatemia in Canada

Ardelyx to Receive Up to CAD 25 Million in Upfront Payment and Subsequent Milestones

MONTREAL, QUEBEC--(Marketwired - March 19, 2018) - Knight Therapeutics Inc. (TSX:GUD) ("Knight") announced today a license agreement with Ardelyx, Inc. (NASDAQ:ARDX)("Ardelyx") that provides Knight with exclusive rights to commercialize tenapanor in Canada. Tenapanor is Ardelyx's oral, first-in-class small molecule treatment that has completed Phase 3 development for irritable bowel syndrome with constipation (IBS-C) and is being evaluated in a second Phase 3 study for hyperphosphatemia.

Under the terms of the agreement, Knight will pay up to CAD 25 million in total payments including an upfront payment and development and sales milestones, as well as double-digit tiered royalties on net sales. Knight will have the exclusive rights to market and sell tenapanor in Canada.

"We are excited to bring Canadian patients a product like tenapanor with its differentiated mechanism and established efficacy and safety profiles in both IBS-C and hyperphosphatemia," said Jonathan Ross Goodman, chief executive officer of Knight. "The addition of tenapanor to our pipeline will further enhance Knight's leadership in GI disorders. Because of its novel mechanism, we believe tenapanor will have advantages in treating IBS-C through an entirely new approach than those of today's approved medicines. In addition, we see great potential for tenapanor as the first and only new option outside of phosphate binders to treat hyperphosphatemia, with an opportunity to make an important difference for patients who would benefit from a new safe, effective and easy to take alternative. We look forward to working with the Ardelyx team and Health Canada to bring tenapanor to Canadian patients."

"Knight has a proven approach of successfully collaborating with biotechnology companies to bring forward important medicines, which makes them an invaluable component to our strategy of working with industry leaders to bring tenapanor to patients with IBS-C and hyperphosphatemia," said Mike Raab, president and chief executive officer of Ardelyx. " With a highly differentiated product profile, we believe that tenapanor will make a meaningful impact on Canadian patients and are pleased to be collaborating with the experienced and proven Knight team to make this a reality."

Knight Conference Call Notice

Knight will host a conference call to discuss the transaction today at 8:00 am ET. Knight cordially invites all interested parties to participate in this call.

A presentation with additional information about the transaction can be found on Knight's website at www.gudknight.com under presentations and will remain available for 30 days.

Date: March 19, 2018
Time: 8:00 a.m. EST
Telephone: 1-877-223-4471 or 647-788-4922
Webcast: http://www.gudknight.com/ or http://bit.ly/2tT9F3P
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
Replay: An archived replay will be available for 30 days at http://www.gudknight.com/

About Tenapanor

Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, minimally absorbed, oral, experimental medication in late-stage clinical development. It has a unique mechanism of action that, in IBS-C, acts by inhibiting, or blocking, the NHE3 transporter in the gastrointestinal (GI) tract to reduce the absorption of dietary sodium, which leads to an increased amount of sodium within the gut. This increased sodium increases water in the gut, which loosens stool, helping to alleviate constipation. Preclinical studies have shown that tenapanor may work to reduce abdominal pain caused by IBS-C through the inhibition of TRPV-1 dependent signaling. Ardelyx has successfully completed its T3MPO program designed to support the registration of tenapanor for the treatment of IBS-C. Collectively, the T3MPO-1 and T3MPO-2 Phase 3 trials demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain caused by IBS-C, in many patients treated. The favorable safety profile of tenapanor is supported by the completed T3MPO-3 long-term, safety extension study. With the completion of this program, Ardelyx is preparing a New Drug Application for tenapanor for IBS-C, which the company intends to submit to the U.S. Food and Drug Administration in the second half of 2018.

Tenapanor is also in Phase 3 development for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis. In hyperphosphatemia, tenapanor blocks the NHE3 sodium transporter in the GI tract, reducing the absorption of dietary sodium and resulting in increased protons within the cells. The increase in protons causes a reduction in phosphate uptake by tightening junctions or pores that regulate phosphate absorption in the GI tract. Overall, this mechanism appears to be preferential to phosphate absorption given that Ardelyx has not observed any meaningful changes in other ions, other than sodium, in preclinical or clinical studies. Ardelyx completed its first Phase 3 clinical trial for tenapanor in hyperphosphatemia, which demonstrated a statistically significant primary endpoint, the difference in change in serum phosphorus between the pooled tenapanor-treated patients and placebo-treated patients from the end of the eight-week treatment period to the end of the four-week randomized withdrawal period, in the responder population. Tenapanor was well-tolerated in the trial. Ardelyx has begun treating patients in a second Phase 3 clinical trial, the Phreedom Trial, with data anticipated in 2019.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gudknight.com or www.sedar.com.

Forward Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2017. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

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