MONTREAL, QUEBEC–(Marketwired – Dec 15, 2016) – Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company today announced the signing of an exclusive license agreement with AstraZeneca, for the rights to Movantik (naloxegol) in Canada and Israel. The financial terms of the agreement were not disclosed.
Movantik, the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) approved in Canada for the treatment of opioid-induced constipation (“OIC”) in adult patients with non-cancer pain who have had an inadequate response to laxative(s), was launched by AstraZeneca in October 2015. Movantik is currently under regulatory review in Israel and, when approved, will be marketed under the name Moventig.
According to the Canadian Family Physician Practice Guideline, it is estimated that at least 26% of chronic opioid users suffer from OIC.
Based on QuintilesIMS, Movantik sales in Canada were $372,000 for the ten-month period ending October 2016.
Under the terms of the exclusive license agreement, Knight will be responsible for all commercial, regulatory and certain supply chain activities for Movantik in Canada and Israel.
“We are pleased to partner with AstraZeneca and to continue their efforts at introducing Movantik to patients in Canada and Israel,” said Jonathan Ross Goodman, CEO of Knight. “Movantik is a unique product that addresses a clear unmet need and will be a great addition to our portfolio of products that treat conditions associated with the use of opioids, such as Probuphine®.”
Conference Call Notice
Knight will host a conference call to discuss the transaction today at 8:00 am ET. Investors and other interested parties may call 1-877-223-4471 (Operator Assisted Toll-Free) or 647-788-4922 (local or international).
A taped replay of the conference call will be available from today at 11:00 am ET until January 15, 2017 at 11:59 pm ET. To access the replay, please call 1-800-585-8367 or 416-621-4642 and use access code 33758691.
Movantik/Moventig is a peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to laxative(s). It is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in Canada. In Phase III clinical studies, Movantik/Moventig was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.
The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12-week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety study.
Movantik/Moventig is part of the exclusive worldwide licence agreement announced on 21 September 2009 between AstraZeneca and Nektar Therapeutics. Movantik/Moventig was developed using Nektar’s oral small molecule polymer conjugate technology.
Moventig was granted Marketing Authorisation by the European Medicines Agency in December 2014. Outside the EU, it was launched in the US in March 2015 and in Canada in October 2015 under the brand name Movantik.
In March 2015, AstraZeneca entered into an agreement with Daiichi Sankyo, Inc., for the co-commercialisation of Movantik in the US and in March 2016, AstraZeneca entered into an agreement with Kyowa Kirin International for the rights to Moventig in the European Union, Iceland, Norway, Switzerland and Liechtenstein.
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.gud-knight.com or www.sedar.com.
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, 2015. 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.