IDM expects L-MTP-PE EC decision in 4th qtr

US drugmaker IDM Pharma has requested additional data analyses from a Phase III trial of its osteosarcoma drug mifamurtide in order to respond to questions raised by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on the recent inspection of the Children's Oncology Group.

The new data will also help address the remaining chemistry, manufacturing and control issues by the end of August, according to the current CHMP timeline, noted the California-headquartered cancer specialist.

This is a welcome piece of good news for the firm which, at the end of last year (Marketletter January 7), saw its share price plummet 18% to a 52-week low of $1.05, after the company announced in mid-December that it was reviewing strategic alternatives following the failure of mifamurtide to gain an approval recommendation from an FDA advisory panel. IDM hopes the committe will consider its responses at its September meeting, when an oral explanation hearing will be held if required. It expects resolution of the remaining issues regarding application in the third quarter, with a final decision in the fourth quarter.