Replidyne Discontinues Phase III Trial
Wednesday April 23, 7:30 am ET
LOUISVILLE, Colo., April 23 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN - News) announced today that it has discontinued enrollment in a placebo-controlled Phase III clinical trial testing faropenem medoxomil (faropenem) in patients with acute exacerbation of chronic bronchitis (AECB). Replidyne took this action to conserve its cash assets and support initiatives that include pursuing strategic transactions and maintaining its research programs.
The AECB study is one in a package of four clinical trials, including two in community-acquired pneumonia and one in acute bacterial sinusitis, recommended as a way forward by the U.S. Food and Drug Administration for a new drug application submission for faropenem to treat these three adult community respiratory tract infections. Replidyne has not initiated the other three trials, and consistent with prior guidance, further faropenem development will depend on Replidyne securing a partner for the program.
"In the interest of conserving our financial position, we have made a difficult decision to discontinue enrollment in this faropenem trial," said Kenneth J. Collins, Replidyne's President and CEO. "This decision reflects our sense of urgency and the belief that in today's environment available cash assets broaden the scope of potential partnering and strategic options."
As of March 31, 2008, Replidyne had cash assets of approximately $78 million.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's most advanced product candidate, 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 investigational antibacterial agent REP3123 targets Gram-positive C. difficile bacteria and C. difficile- associated disease (CDAD). Replidyne is pursuing the development of other novel anti-infective programs based on its DNA replication inhibition technology and its in-house discovery research.
surf's up......crikey
