Replidyne Completes Phase 2 Trial Enrollment

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials;  Pediatrics / Children's Health
Article Date: 21 Dec 2006 - 0:00 PDT

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Replidyne, Inc. (Nasdaq: RDYN) announced today that it has completed enrollment for a Phase 2 trial evaluating faropenem medoxomil (faropenem) in pediatric patients with acute otitis media (AOM), an infection of the middle ear. AOM is the most frequent pediatric bacterial infection that results in the prescription of an antibiotic and accounts for 30 million office visits in the US annually(1).

This comprehensive study including over 300 children will provide pharmacokinetic, safety and clinical outcome data with different treatment doses while also determining bacteriologic outcomes. Results for the trial are expected by the end of the first quarter in 2007.

In February 2006, Replidyne entered into a collaboration agreement with Forest Laboratories (Forest) to develop and commercialize faropenem in the US, including developing an oral liquid formulation of faropenem for the pediatric market. Under the agreement with Forest, Replidyne has the option to exclusively promote faropenem to pediatricians.

"We are pleased to advance this important pediatric program, a key component in building our initial commercial organization," said Kenneth J. Collins, Replidyne's President and CEO. "Faropenem has a demonstrated safety profile and in the future could provide caregivers with a much needed safe and effective treatment for children."

About AOM

Acute otitis media (AOM) is a condition resulting from infection of the middle ear fluid (MEF) and symptoms include severe malaise, irritability, decreased oral intake, vomiting and fever with or without ear complaints. AOM remains a major burden of illness due to both its high incidence and complications resulting from a shift of disease to younger children due to increased use of day care(2).

About Faropenem Medoxomil

Replidyne's lead product candidate, faropenem medoxomil (faropenem), is a novel oral community antibiotic under development for the treatment of respiratory and other community infections. Faropenem is a member of the penem sub-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 typically first-line therapy in many respiratory and skin infections in adult and pediatric patients.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. In February 2006, Replidyne entered into a partnership agreement with Forest Laboratories to develop and commercialize faropenem medoxomil in the US. An IND for Replidyne's second drug candidate, REP8839, was submitted to the FDA in May 2006. REP8839 is a topical anti-infective product under development for the treatment of skin and wound infections, and the prevention of S. aureus infections, including multiple antibiotic-resistant S. aureus (MRSA) infections, in hospital settings. 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 http://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.

(1) Bondy J, Berman S, Glazner J, Lezotte D. Direct expenditures related to otitis media diagnoses: extrapolations from a pediatric medicaid cohort. Pediatrics 2000 Jun;105(6):E72.

(2) Capra AM, Lieu TA, Black SB, Shinefield HR, Martin KE, Klein JO. Costs of otitis media in a managed care population. Pediatr Infect Dis J 2000 Apr;19(4):354-5.

Replidyne, Inc.
http://www.replidyne.com/

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