Healthcare Industry News:  sinusitis 

Biopharmaceuticals FDA

 News Release - January 9, 2006

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

LOUISVILLE, Colo., Jan. 9 (HSMN NewsFeed) -- Replidyne, Inc., a privately held biopharmaceutical company focused on the discovery and development of new anti-infective drugs, announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Orapem(TM) (faropenem medoxomil) for the treatment of the following conditions: acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis and uncomplicated skin and skin structure infections. This NDA is the first marketing approval submission for Orapem(TM) worldwide and was submitted in the electronic common technical document (eCTD) format. It is also the first NDA submission for the Company.

The Orapem(TM) submission is primarily based on data from eleven Phase III clinical trials which assessed the clinical and microbiological efficacy as well as the safety and tolerability profile of Orapem(TM) in treating respiratory tract and skin infections. The safety database included more than 5,000 Orapem(TM) treated patients from clinical trials.

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

Replidyne acquired exclusive rights to Orapem(TM) in March 2004 from Daiichi Asubio Pharma Co., Ltd. for the U.S. and Canada and an exclusive option to the rest of the world, except Japan. Orapem(TM) was discovered by scientists at Suntory Institute for Biomedical Research, now Daiichi Asubio Pharma 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 most well-studied members of the penem class and the only penem that is orally bioavailable. The prodrug form of faropenem offers a dramatically improved oral bioavailability and leads to higher systemic concentrations of the drug.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on developing and commercializing innovative anti-infective products. Replidyne's current development programs include higher dose/shorter course therapy, additional indications for adults, and a pediatric formulation of Orapem(TM). The Company's pipeline also includes a topical anti-bacterial product, REP8839, which has a novel mechanism of action for addressing the major challenge of methicillin-resistant Staphylococcus aureus (MRSA). Replidyne also has discovery programs directed to the inhibition of bacterial DNA replication, which could result in therapies to treat a wide range of antibiotic-resistant bacteria. For additional information about Replidyne, Inc., please visit:

Source: Replidyne

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