FDA delays PDUFA date for Impavido

Paladin Labs Inc. (TSX:PLB) said FDA delayed by three months the PDUFA date for an NDA for Impavido miltefosine to treat cutaneous, mucosal, and visceral leishmaniasis. The new date is March 19, 2014; it was Dec. 19. Paladin said it submitted revisions on CMC details and "other aspects related to the proposed label" for Impavido. Last month, FDA's Anti-Infective Drugs Advisory Committee backed approval of Impavido, which Paladin gained from Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) in 2008. The alkylphosphocholine analog that inhibits CTP phosphocholine cytidylyl transferase is approved for leishmaniasis in Europe, India and Central and South America (see BioCentury Extra, Oct. 18).

Fellow specialty pharma Endo Health Solutions Inc. (NASDAQ:ENDP) is acquiring Paladin for about $1.6 billion in a deal expected to close in 1H14. In connection with the deal, Impavido will be spun off into a newco that will be owned by Paladin shareholders (see BioCentury Extra, Nov. 5). ...