MONTREAL, QUEBEC–(Marketwired – Apr 25, 2016) – Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, today announced that it has received a Notice of Deficiency (“NOD”) for its ATryn® New Drug Submission.
In its notice, Health Canada requested additional technical information on ATryn® in order to complete its assessment of the product.
“Such requests are not unusual during the regulatory review. I am confident that we can work through Health Canada’s questions towards approval”, said Jonathan Ross Goodman, President and CEO of Knight. “ATryn® is approved for sale in both the U.S. and Europe, and touches the lives of patients with hereditary antithrombin deficiency. We look forward to working with Health Canada to bring this important treatment option to Canadian patients.”
ATryn® is a recombinant human antithrombin. If approved, ATryn® would be used for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. “ATryn®, is the first and only recombinant antithrombin concentrate.” ATryn® received EMA approval in 2006 and FDA approval in 2009, for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
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.