LOUISVILLE, Colo., March 27 /PRNewswire-FirstCall/ -- Replidyne, Inc. announced today a preliminary regulatory plan resulting from its ongoing discussions with the U.S. Food and Drug Administration (FDA) for the further Phase III development of faropenem medoxomil (faropenem). Faropenem is a novel oral community antibiotic that if approved could be one of the first products to meet the FDA’s new standards for community antibiotic development. New treatment options are necessary as, according to the Centers for Disease Control and Prevention, nearly all significant bacterial infections in the world are becoming resistant to the most commonly prescribed antibiotic treatments.
In its communications with Replidyne to date, the FDA has indicated that a total of four Phase III clinical trials in three adult respiratory indications will be sufficient for a new drug application (NDA) for faropenem. These indications are acute bacterial sinusitis (ABS), community acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB). According to this plan, Replidyne could conduct two active-controlled, non-inferiority studies using faropenem in patients with CAP, as well as one placebo-controlled superiority trial each in patients with ABS and AECB to submit for approval of these three indications. Replidyne and the FDA have agreed that future clinical trials of faropenem will be conducted using a 600 mg dose, administered twice daily. The FDA has further indicated that an acceptable safety database needed for review at this dose is approximately 1500 patients, assuming no safety signals emerge during the studies. The proposed four Phase III studies in three adult respiratory indications are expected to provide this requisite safety database. Replidyne is continuing to work with the FDA to define the specific details that will permit the timely enrollment of patients in these proposed new studies.
“It has been our highest priority to gain regulatory clarity for faropenem and we are encouraged by the progress in our discussions with the FDA to date,” said Kenneth J. Collins, Replidyne’s President and CEO. “We have confidence in faropenem’s potential benefit to patients and believe that with these additional studies it can meet the new approval standards leading to significant commercial value.”
About Faropenem
Faropenem is a member of the penem class within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are often used as first line therapy in many respiratory and skin infections in adult and pediatric patients.
In October 2006, the FDA issued a non-approvable letter to Replidyne for faropenem in acute bacterial sinusitis (ABS), community acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (uSSSI). In its letter, the FDA recommended further clinical studies, including studies using a superiority design for ABS and AECB, more extensive microbiologic confirmation, and consideration of alternate dosing regimens. The FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to faropenem.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne’s lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne’s second drug candidate, REP8839, is a topical anti-infective product under Phase I development for the treatment of skin and wound infections, including methicillin-resistant S. aureus (MRSA) infections. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research.
Safe Harbor
This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company’s ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company’s product candidates and the Company’s ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company’s ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company’s sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company’s Form S-1 and most recent periodic report filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC’s electronic data gather analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.
Replidyne, Inc.
CONTACT: Sabrina B. Oei, Dir. Investor & Public Relations, Replidyne,Inc., +1-303-996-5535
Web site: http://www.replidyne.com/
