Monday, January 09, 2006

Replidyne Submits New Drug Application (NDA) for Orapem(TM) (Faropenem Medoxomil)

Replidyne Submits New Drug Application (NDA) for Orapem(TM) (Faropenem Medoxomil) to U.S. Food and Drug Administration

LOUISVILLE, Colo., Jan. 9 /PRNewswire/ -- Replidyne, Inc., a privatelyheld biopharmaceutical company focused on the discovery and development of newanti-infective drugs, announced that the Company has submitted a New DrugApplication (NDA) to the U.S. Food and Drug Administration for Orapem(TM)(faropenem medoxomil) for the treatment of the following conditions: acutebacterial sinusitis, community acquired pneumonia, acute exacerbations ofchronic bronchitis and uncomplicated skin and skin structure infections. ThisNDA is the first marketing approval submission for Orapem(TM) worldwide andwas submitted in the electronic common technical document (eCTD) format. It isalso the first NDA submission for the Company.

The Orapem(TM) submission is primarily based on data from eleven Phase IIIclinical trials which assessed the clinical and microbiological efficacy aswell as the safety and tolerability profile of Orapem(TM) in treatingrespiratory tract and skin infections. The safety database included more than5,000 Orapem(TM) treated patients from clinical trials.

"The submission of the Orapem(TM) NDA represents a significant achievementby Replidyne, and the culmination of the efforts of a dedicated team. It alsomarks a substantial step in the Company's growth as we now expand our focustoward commercialization," said Kenneth J. Collins, president and CEO ofReplidyne. "We have been aggressive in our efforts to build a pipeline ofnovel antibacterial programs and the submission of the NDA for Orapem(TM)validates those efforts. If approved, it will mark the introduction of thefirst oral antibiotic of the penem class to be marketed in the United States."

Replidyne acquired exclusive rights to Orapem(TM) in March 2004 fromDaiichi Asubio Pharma Co., Ltd. for the U.S. and Canada and an exclusiveoption to the rest of the world, except Japan. Orapem(TM) was discovered byscientists at Suntory Institute for Biomedical Research, now Daiichi AsubioPharma Co., Ltd. and is manufactured by Nippon Soda Co., Ltd. (Tokyo, Japan).

About Orapem(TM) Orapem(TM) is an ester prodrug derivative of faropenem, one of the mostwell-studied members of the penem class and the only penem that is orallybioavailable. The prodrug form of faropenem offers a dramatically improvedoral bioavailability and leads to higher systemic concentrations of the drug.

About Replidyne, Inc. Replidyne is a biopharmaceutical company focused on developing andcommercializing innovative anti-infective products. Replidyne's currentdevelopment programs include higher dose/shorter course therapy, additionalindications for adults, and a pediatric formulation of Orapem(TM). TheCompany's pipeline also includes a topical anti-bacterial product, REP8839,which has a novel mechanism of action for addressing the major challenge ofmethicillin-resistant Staphylococcus aureus (MRSA). Replidyne also hasdiscovery programs directed to the inhibition of bacterial DNA replication,which could result in therapies to treat a wide range of antibiotic-resistantbacteria.

For additional information about Replidyne, Inc


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