MEMY Trial Halted...FDA wants more information

FDA Requests Further Information

Memory Pharma provides update on Phase 2a trial of MEM 3454 in alzheimer's disease; FDA requires further explanations of revisions Co announces an update on the investigational new drug application filed in Sept 2006 with the FDA for MEM 3454.

The FDA has advised the co that in order to fully review the toxicology reports that were submitted with the I.N.D, the agency requires further explanations of revisions that were made to those reports since they were submitted with the co's first I.N.D for this trial in May, and as a result the proposed Phase 2a clinical trial for MEM 3454 in Alzheimer's disease has been placed on clinical hold. The FDA has also deferred assessment of the adequacy of the Investigator's Brochure for the trial pending submission of the additional information.

MEMY also reported that the FDA confirmed that the clinical hold was not related to any manufacturing issues with MEM 3454 and that the potential impurities issue, previously raised by the FDA in connection with the co's first IND for the proposed Phase 2a clinical trial of MEM 3454, had been adequately resolved. The co believes that no additional studies or data will be required to address the FDA's questions and that, as a result, it should be able to provide to the FDA, by early November, the information necessary to facilitate the FDA's review


The nicotinic alpha-7 receptor target represents a novel approach to thetreatment of CNS disorders, and we are pleased by the rapid progress of MEM3454," said Peter Hug, Roche's Global Head of Pharma Partnering. "Ourrelationship with Memory Pharmaceuticals has been a productive one and allowsus to leverage their strengths in CNS drug discovery and development.