Awarded Priority Review Voucher
MONTREAL, QUEBEC–(Marketwired – March 19, 2014) – Knight Therapeutics Inc. (“Knight”) (TSX VENTURE:GUD) today announced that the U.S. Food and Drug Administration (FDA) has approved Impavido® (Miltefosine) for patients with Visceral, Mucosal and Cutaneous Leishmaniasis. Also received today was a Priority Review Voucher, which is designed to be transferable or sold and provides the bearer with an expedited FDA review for any new drug application.
“We are thrilled to get Impavido approved for patients and to be the fourth company in the world to receive a Priority Review Voucher,” said Jonathan Ross Goodman, President and Chief Executive Officer of Knight, “and we would like to thank the many team members at Paladin Labs Inc. for all their hard work. Our plan is to commercialize Impavido in the United States and to monetize the voucher for maximum value, which may take time to materialize.”
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 the TSX-V on March 3, 2014 under the symbol GUD. For more information about Knight Therapeutics, please visit the Company's web site at www.gud-knight.com or at www.sedar.com.
About Impavido® (miltefosine):
Impavido® (miltefosine) is an oral alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. Miltefosine was included in the WHO essential medicines list as an anti-leishmaniasis medicine in March 2011.
Leishmania organisms are intracellular protozoan parasites that are transmitted to a mammalian host by the bite of the female phlebotomine sandfly. The main clinical syndromes are visceral leishmaniasis, cutaneous leishmaniasis, and mucosal leishmaniasis. In the United States, leishmaniasis may be seen in returning travelers following exposure in endemic regions, and in American soldiers serving in Iraq, Afghanistan or South America.
The WHO estimates that approximately 400,000 new cases of visceral leishmaniasis occur annually world-wide. Approximately 0.7-1.2 million new cutaneous leishmaniasis cases occur annually world-wide.
About Priority Review Voucher:
Developed by the U.S. FDA in 2007, a Priority Review Voucher (“PRV”) is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. A Priority Review means that the time it takes the FDA to review a new drug application is reduced. The PRV is transferable and can be sold and entitles the bearer to a priority review for any product. To date, only 3 companies have received a PRV and none have been sold.
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 the TSX Venture Exchange and 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 and except as required by law.
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