MONTREAL, CANADA--(Marketwired - Nov. 11, 2013) - Paladin Labs Inc. ("Paladin") (TSX:PLB), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has notified Paladin that it is extending the Prescription Drug User Fee Act (PDUFA) goal date for its new drug application (NDA) for Impavido® (miltefosine) for the treatment of cutaneous, mucosal, and visceral leishmaniasis from December 19, 2013 to March 19, 2014.
During the course of recent discussions with the FDA, Paladin submitted revisions regarding chemistry, manufacturing and control (CMC) details and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date to March 19, 2014. The FDA has not requested at this time any additional clinical studies prior to the revised PDUFA action date.
"We appreciate the efforts of the FDA to review the Impavido NDA in this review cycle, and will continue to support their review in any way possible," said Mark Beaudet, interim President & CEO of Paladin Labs.
As announced on November 5, 2013, in connection with the transaction with Endo Health Solutions Inc. (NASDAQ: ENDP), Impavido will be spun off to a new company, Knight Therapeutics Inc., the shares of which will be owned by the shareholders of Paladin.
"We remain both committed to bringing this novel treatment for leishmaniasis to patients in the United States and rapidly closing our transaction with Endo," said Jonathan Ross Goodman, Chairman of Paladin Labs Inc.
Impavido is an oral agent for the treatment of leishmaniasis and is currently the only oral treatment for leishmaniasis approved for sale in Europe, the Indian subcontinent, and Central and South America. Impavido has been granted orphan designation and fast-track status by the FDA, and has qualified for priority review.
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).
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.
||The Selection and Use of Essential Medicines: report of the WHO Expert Committee, March 2011, WHO Technical Report Series 965 (2012).
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.