Paladin Receives Priority Review Status from FDA for Impavido® NDA Submission
If approved, Paladin to receive priority review voucher through the Tropical Disease Voucher Program
MONTREAL, CANADA--(Marketwired - June 19, 2013) - Paladin Labs Inc. ("Paladin")(TSX:PLB) announced today that it has received notice that its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Impavido® (miltefosine) has been accepted for review and has been granted priority review status. If approved, Paladin will be authorized to commercialize Impavido in the U.S. and will receive a priority review voucher through the FDA's tropical disease priority review voucher program. The FDA has informed Paladin that the Prescription Drug User Fee Act (PDUFA) action date will be December 19, 2013.
Impavido is an oral agent for the treatment of leishmaniasis which Paladin acquired on a worldwide basis from Aeterna Zentaris in 2008. Impavido is currently the only oral treatment for leishmaniasis approved for sale in Europe, the Indian subcontinent, and Central and South America.
Priority reviews are granted to drugs that potentially offer major advances in treatment, or that potentially provide a treatment where no adequate therapy currently exists. A priority review granted by the FDA reduces the target review time for a NDA from the standard target of ten months to a target of six months.
Leishmaniasis is one of the diseases targeted by the FDA for innovation and development of new therapies through their tropical disease priority review voucher program. Under this program, if a therapy for a selected tropical disease qualifies for priority review and receives FDA approval, the sponsor will be awarded a priority review voucher. A priority review voucher entitles the bearer to a priority review of a future NDA that would not otherwise qualify for such a review. A priority review voucher is transferable and can be sold to another organization.
"We are pleased that the FDA has accepted to review our application for Impavido® and granted us priority review status," said Mark Beaudet, interim President & CEO of Paladin Labs. "Leishmaniasis is a neglected tropical disease for which research and medical breakthroughs are rare and we believe that, if approved, Impavido® can bring important benefits to US patients suffering from this disease."
Leishmaniasis is a parasitic disease transmitted by a species of sandfly (Phlebotomus sp. and Lutzomyia sp.) and is found in over 80 countries worldwide. It is estimated that 350 million people are at risk for leishmaniasis. Twelve million people are currently infected, with 1.5-2 million new cases being reported annually, and 70,000 deaths occurring annually. While exact data on incidence of leishmaniasis is not available for the United States, persons immigrating/travelling from endemic countries, military personnel, and immunocompromised patients are most at risk for infection.
Based on the evidence of safety and efficacy from multiple clinical studies, miltefosine has been recognized by the World Health Organization (WHO) as being one of only five therapeutic agents to be placed on their Essential Medicines List for the treatment of leishmaniasis (1).
(1) The Selection and Use of Essential Medicines: report of the WHO Expert Committee, March 2011, WHO Technical Report Series 965 (2012).
About Paladin Labs Inc.
Paladin Labs 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. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company's web site at www.paladinlabs.com.
Paladin Labs 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 annual report as well as in the Company's Annual Information Form for the year ended December 31, 2012. 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. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.