Replidyne Seeks Another Partner Before Conducting New Phase III Orapem Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests four additional studies to reconsider a new NDA for antibiotic candidate that was previously deemed “not approvable.”
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Although it has received additional guidance from FDA, Replidyne will not proceed with additional Phase III studies for its experimental antibiotic Orapem (faropenem medoxomil) until it finds a new partner, the firm told "The Pink Sheet" DAILY. The Louisville, Colo.-based company announced March 27 that FDA has stated that four new studies will be needed to support a new NDA. In October, the agency issued a "not approvable" letter for four indications (1 (Also see "Forest’s Faropenem Is “Not Approvable”; Additional Studies Will Take Two Years" - Pink Sheet, 23 Oct, 2006.)). In its latest communication, FDA requested Replidyne conduct two Phase III noninferiority studies in patients with community-acquired pneumonia, and one superiority trial each in acute bacterial sinusitis and acute exacerbations of bacterial sinusitis. All four trials will utilize a 600 mg dose given twice daily. Replidyne told "The Pink Sheet" DAILY it is now in a better position to seek a partner to continue Orapem's development following the FDA guidance and positive Phase II pediatric results of faropenem in acute otitis media released earlier this month (2 (Also see "Phase II Pediatric Results A Boost For Replidyne’s Faropenem" - Pink Sheet, 8 Mar, 2007.)). The firm also said a Phase III study halted in December comparing Orapem with Sanofi-Aventis' Ketek (telithromycin) is to resume soon, though with a different comparator. In February, Forest backed out of an agreement for development of Orapem, leaving Replidyne without a major partner to continue development of the antibiotic (3 (Also see "Replidyne Seeks New Partner For Orapem After Forest Backs Out Of Development" - Pink Sheet, 7 Feb, 2007.)). - Jonathan M. Block ([email protected]) |