FDA panel to discuss Paladin's leishmaniasis compound

FDA's Anti-Infective Drugs Advisory Committee will meet on Oct. 18 to discuss an NDA for Impavido miltefosine from Paladin Labs Inc. (TSX:PLB) to treat leishmaniasis. The compound is under Priority Review, with a Dec. 19 PDUFA date. Impavido is approved for leishmaniasis in Europe, India and Central and South America. Paladin acquired the alkylphosphocholine analog that inhibits CTP phosphocholine cytidylyl transferase from Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) in 2008.

Paladin said it is eligible for a Priority Review voucher if FDA approves Impavido. The transferrable voucher entitles the bearer to priority FDA review for another drug. The voucher program was started in 2007 to create incentives to develop drugs for neglected tropical diseases (see BioCentury, Aug. 8, 2011). ...