MONTREAL, QUEBEC–(Marketwired – Nov. 19, 2014) – Knight Therapeutics Inc., (TSX:GUD) through one of its wholly owned subsidiaries (“Knight”), today announced the sale of its Neglected Tropical Disease Priority Review Voucher (“PRV”). The PRV was granted to Knight in March of this year with the approval of Impavido® (miltefosine) for treatment of patients with visceral, mucosal and cutaneous leishmaniasis. Upon closing of the transaction, Knight will receive US$125 million in cash from Gilead Sciences, Inc. in exchange for the PRV. Knight was advised in the transaction by global investment banking firm, Jefferies LLC.
“We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity” said Jonathan Ross Goodman, Director of Knight.
About the Neglected Tropical Disease Priority Review Voucher Program
Developed by the U.S. FDA in 2007 under the Food and Drug Administration Amendments Act (“FDAAA”), a PRV is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. Leishmaniasis is considered a neglected tropical disease and is one of 16 tropical diseases that qualify for a PRV. A PRV is a transferrable asset that entitles the holder to a priority review for a drug of its choice. Under Prescription Drug User Fee Act (“PDUFA”), the FDA sets a target of 10 months from the date the FDA accepts the application for a standard review of a New Drug Application (“NDA”) or a Biologic License Application (“BLA”). A priority review means that the FDA reduces its target review time for an NDA or BLA to 6 months from the date the FDA accepts the application, speeding up the initial review of the drug.
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 world markets. Knight Therapeutics' shares began trading on TSX-V on March 3, 2014 and graduated to TSX on April 29, 2014 under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or at www.sedar.com.
Knight Therapeutics Forward-Looking Statement
This press release may contain forward-looking statements and predictions. 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. The company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the company 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 the company's final application for listing on TSX Venture Exchange and in two short form prospectuses which can be found on SEDAR at www.sedar.com, which investors should consult for additional information. The company 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.