FDA provides feedback on the pending NDA for EXALGO tablets

Nov 17 2009

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGO^TM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA). In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA). Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, Inc., who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2) of the FDCA, which utilizes different criteria to determine the basis for approval of a new drug candidate.

So that each company's stockholders can be provided with additional information regarding these developments, CombinatoRx and Neuromed each plan to convene their respective stockholders meetings at the previously scheduled times and then adjourn these meetings until, in the case of CombinatoRx, 9:00 a.m. ET on November 30, 2009, at the offices of Goodwin Procter LLP, 53 State Street, Boston, MA 02109, and in the case of Neuromed, 8:00 a.m. PT on November 30, 2009, at Neuromed’s offices, 301 – 2389 Health Science Mall, Vancouver, BC V6T1Z3.

The U.S. rights to Exalgo™ were acquired by Mallinckrodt, Inc., a Covidien company, on June 11, 2009. CombinatoRx and Neuromed entered into a definitive merger agreement on June 30, 2009.