ProStrakan falls on product delays

ProStrakan Group plc (LSE:PSK) fell 25.50p (32%) to 53p on Tuesday after reporting delays for two products and the departure of its CEO. FDA told the company it will not meet the expected PDUFA date in early September for an NDA for Abstral fentanyl to treat breakthrough cancer pain. ProStrakan said the delay was due to ongoing discussions with FDA regarding the REMS for Abstral. FDA previously extended the original PDUFA date of June 4 by three months after ProStrakan submitted additional information on its proposed REMS at the agency's request. ProStrakan has rights to the sublingual mucoadhesive fentanyl in North America and Europe from Orexo AB (SSE:ORX). Orexo was down SEK1.70 to SEK38.80 on Tuesday.

ProStrakan also said it will not be able to meet customer demand for Sancuso granisetron patch beginning in early October after its manufacturer stopped production for 8-12 weeks to make changes to internal quality assurance systems. ProStrakan announced the decision by the manufacturer, Aveva Drug Delivery Systems, in August. ProStrakan expects to recommence distribution in 1Q11. ProStrakan said the interruption will negatively affect its 2010 operating profit by up to L5 million ($7.7 million). Sancuso, which is marketed in the U.S. for chemotherapy-induced nausea and vomiting (CINV), had 2009 sales of L7.3 million ($11.8 million). ...