Replidyne stock crashes on FDA non approval letter

LOUISVILLE, Colo. and NEW YORK, Oct. 23-- Replidyne, Inc. and Forest Laboratories, Inc. reported today the U.S. Food and Drug Administration (FDA) has issued a non- approvable letter for Replidyne's new drug application (NDA) for faropenem medoxomil, a novel oral, community antibiotic. Replidyne submitted the NDA in December 2005 for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). The NDA as filed was based on the results of eleven Phase III clinical trials for these indications and a safety data base of more than 5,000 patients treated with faropenem.

According to the non-approvable letter, the FDA recommends further clinical studies for all indications. For ABS and AECB, superiority studies may be needed and for CAP, studies requiring additional microbiologic evaluation. In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product. Replidyne and Forest intend to discuss the clinical plans with the FDA including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies.

Historically the FDA has not required superiority design studies such as placebo-controlled studies for approval for antibiotics, but the Companies believe that recent public FDA deliberations over the need for placebo- controlled studies for antibiotics were a factor in its decision. Further, recent FDA statements have reflected a preference for superiority studies in ABS.

Faropenem medoxomil is in the penecillin class of antibiotics as based on their four-membered lactam ring. It is an inhibitor of bacterial cell wall synthesis, which maintains the shape of the cell.


RDYN (NASDAQ)closed down in trading today 45% to $5.59. OUCH!