Replidyne Discontinues Phase III Trial
23 Avril 2008 - 2:30PM
PR Newswire (US)
LOUISVILLE, Colo., April 23 /PRNewswire-FirstCall/ -- Replidyne,
Inc. (NASDAQ:RDYN) 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. 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 a new partner
for faropenem on acceptable terms; 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 most recent Form 10-K 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 gathering 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. DATASOURCE: Replidyne, Inc. CONTACT: Sabrina B. Oei,
Dir. Investor & Public Relations of Replidyne, Inc.,
+1-303-996-5535 Web site: http://www.replidyne.com/
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