MENLO PARK, Calif., May 7 /PRNewswire-FirstCall/ -- Citing issues
related to potentially sub-optimal therapeutic dosing of paclitaxel, Conor
Medsystems, LLC has concluded that the COSTAR II (CObalt Chromium STent
with Antiproliferative for Restenosis) trial, the pivotal study for the
CoStar(R) cobalt chromium paclitaxel-eluting coronary stent, failed to meet
its primary endpoint. The trial did not identify safety issues, and the
overall rates of death, myocardial infarction and stent thrombosis were
consistent with those observed in other clinically relevant drug-eluting
stent studies.
As a result of these outcomes, the company will terminate ongoing
clinical trials with the CoStar(R) stent and will not conclude the
submission of its Pre-Market Approval application to the U.S. Food and Drug
Administration for the product. Further, Conor Medsystems will discontinue
sale of the product through commercial partners in certain countries in
Europe, Asia and Latin America where the CoStar stent is already approved,
and will work with those partners to facilitate return of product in
inventory in customer accounts.
The COSTAR II trial compared the CoStar(R) stent with the Taxus
Express(2) paclitaxel drug-eluting stent, and was designed to demonstrate
non-inferiority at eight-month follow-up with respect to major adverse
cardiac events (MACE) in patients with multi-vessel or single-vessel
disease. In this trial, MACE was defined as a composite of clinically
driven target vessel revascularization, heart attack (new myocardial
infarction) related to the target vessel and cardiac death related to an
intervened vessel.
"While we are disappointed in these results, we remain optimistic about
the ability of the novel Conor Medsystems reservoir platform to provide
precise and controlled delivery of a therapeutic agent based on earlier
proof of concept testing and trials," said Campbell Rogers, M.D., chief
technology officer, cardiovascular franchise. "Unfortunately, the dose of
paclitaxel used in this trial was ineffective. We expect that the continued
development of sirolimus on this platform will demonstrate promising
outcomes, because sirolimus has been shown to be a versatile and potent
anti-restenosis agent with a wide therapeutic dosing range."
Sirolimus is the proven drug used with the CYPHER(R) Sirolimus-eluting
Coronary Stent -- the most widely studied coronary stent in the world.
"While the safety data from this trial are consistent with other
drug-eluting stent studies, it was disappointing that this product did not
meet the high standards for efficacy that our product portfolio
represents," said Rick Anderson, Johnson & Johnson Company Group Chairman
and worldwide cardiovascular franchise leader. "At the same time, as we
have indicated since the acquisition of Conor Medsystems, we are
enthusiastic about the development of this platform with a versatile,
highly effective drug like sirolimus. Going forward, our clinical program
will be heavily focused on the study of sirolimus on the platform, as well
as on investigating the vast library of therapeutic agents accessible to
our scientists through the research and development programs of
pharmaceutical companies in the Johnson & Johnson family of companies."
Data from the pivotal trial will be presented at the upcoming EuroPCR
meeting to be held May 22 to 25 in Barcelona, Spain.
Conor Medsystems, LLC, a wholly-owned subsidiary of Johnson & Johnson
(NYSE: JNJ), develops innovative controlled vascular drug delivery
technologies and has primarily focused on the development of drug-eluting
stents to treat coronary artery disease. For further information about
Conor Medsystems and controlled vascular delivery, visit http://www.conormed.com.
NOTE TO INVESTORS
Johnson & Johnson will conduct a conference call with financial
analysts to discuss this news release today at 8:30 a.m., EST. A
simultaneous webcast of the call for interested investors and others may be
accessed by visiting the Johnson & Johnson website at http://www.investor.jnj.com.
A replay and podcast will be available approximately two hours after the
live webcast by visiting http://www.investor.jnj.com.
(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the expectations and projections
reflected in this press release. Risks and uncertainties include general
industry conditions and competition; technological advances and patents
attained by competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign health care
reforms and governmental laws and regulations; and trends toward health
care cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December 31,
2006. Copies of this Form 10-K, as well as subsequent filings, are
available online at http://www.sec.gov or on request from Johnson & Johnson or
Conor Medsystems, LLC. Neither Johnson & Johnson nor Conor Medsystems
undertakes to update any forward-looking statements as a result of new
information or future events or developments.)
SOURCE Conor Medsystems
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