Replidyne, Inc.
(Nasdaq: RDYN), reported today that the current phase III clinical trial
comparing faropenem medoxomil (faropenem) to placebo and Ketek
(telithromycin) in patients being treated for acute exacerbation of chronic
bronchitis (AECB) is being temporarily stopped to consider the exclusion of
the Ketek arm in the study. This decision has been made in response to the
findings from the December 14 and 15, 2006 joint Advisory Committee meeting
of the FDA's Anti-Infective Drug and Drug Safety and Risk Management
committees that considered the benefit risk of Ketek for the indication of
AECB. The Advisory Committee recommended to the FDA that the risks of Ketek
outweigh the benefits of using the drug for the treatment of patients with
AECB in a 17 to 2 vote.
"We believe that stopping enrollment in this trial to consider the
inclusion of Ketek in the study is the appropriate and responsible action
at this time to consider the new scientific evidence presented at the
recent FDA Advisory Committee meeting," said Kenneth J. Collins, President
and Chief Executive Officer of Replidyne. "While this action will cause a
delay in obtaining the results from this AECB study we do not expect that
it will impact the total time to complete the clinical program required to
support the overall submission for the adult respiratory indications of
Acute Bacterial Sinusitis (ABS), Community Acquired Pneumonia (CAP) and
AECB. This action today will not impact the development of our pediatric
clinical program for faropenem."
The phase III clinical trial for AECB is designed to compare faropenem
to placebo and Ketek, an approved ketolide antibiotic. The primary
objective of the study is to demonstrate superiority of faropenem to
placebo. The additional comparison to Ketek represented a secondary
analysis and was initially included primarily for commercial competitive
reasons.
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
sec. 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.
replidyne
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