Conor Medsystems Licenses Pimecrolimus From Novartis for Use in Next-Generation Reservoir-Based Drug-Eluting Stents
March 16 2006 - 9:00AM
PR Newswire (US)
MENLO PARK, Calif., March 16 /PRNewswire-FirstCall/ -- Conor
Medsystems, Inc. (NASDAQ:CONR) today announced that the company
exercised its option to obtain a worldwide, non-exclusive license
from Novartis Pharma AG (NYSE:NVS) to the pharmaceutical compound
pimecrolimus for use with Conor's next-generation controlled
vascular drug delivery technologies. Conor expects to begin a
clinical trial this year evaluating the therapeutic potential of
two novel stents incorporating pimecrolimus for the treatment of
coronary artery disease. Both stents will utilize the company's
reservoir-based cobalt chromium drug-eluting stent platform. One
stent will be loaded with pimecrolimus, and the other stent will be
a dual-drug stent loaded with both pimecrolimus and paclitaxel. The
initiation of this clinical trial will position Conor as a leader
in dual-drug delivery stents. "We are very pleased to expand our
pipeline of product candidates through the licensing of
pimecrolimus from Novartis and look forward to furthering the
development of our drug-eluting stents," said Frank Litvack, M.D.,
Chairman and CEO of Conor. "The unique reservoir design of Conor's
drug-eluting stent platform enables us to explore novel
therapeutics and new therapeutic combinations for treating coronary
artery disease. Our pre-clinical studies conducted with
pimecrolimus indicate that the compound's anti-inflammatory
properties may be beneficial in treating vascular diseases, making
this new product an exciting candidate for the treatment of
restenosis." Under the terms of the licensing agreement with
Novartis, Conor is responsible for product development, including
clinical trials, manufacturing and regulatory filings, and will pay
Novartis licensing fees, milestone payments and royalties on
product sales. Novartis will supply Conor with pimecrolimus and
will collaborate with Conor on the regulatory and technical issues.
Further terms of the agreement were not disclosed. Pimecrolimus is
a cell-selective inhibitor of the production and release of
pro-inflammatory cytokines. Inflammation is believed to be one of
the key mechanisms in restenosis as well as other vascular
inflammatory diseases such as unstable plaques and diabetic
lesions. In March of 2005, Conor and Novartis announced an
agreement to evaluate three Novartis pharmaceutical agents --
imatinib mesylate, pimecrolimus and a pre-commercial compound,
midostaurin -- for the potential development of a product combining
a Novartis compound with Conor's reservoir-based drug-eluting
stents for the treatment of vascular diseases. Pimecrolimus was
selected for licensing by Conor following pre-clinical studies of
all three compounds in combination with Conor's drug-eluting stent
platform. In contrast to conventional surface-coated stents,
Conor's stent has been specifically designed for vascular drug
delivery. Conor's stent incorporates hundreds of small holes, each
acting as a reservoir into which drug-polymer compositions can be
loaded. Through this proprietary design, Conor believes that it can
greatly enhance control of the rate and direction of drug delivery,
enable a wider range of drug therapies, and potentially increase
the range of clinical applications of drug eluting stents. In
addition, Conor's stents use bioresorbable polymers that are
absorbed by the body after the drug is released, leaving no
permanent residual polymers or drug at the target site. In
February, Conor received CE Mark approval for its CoStar(TM)
paclitaxel-eluting stent for the treatment of coronary artery
disease which is currently being marketed in the European Union and
other countries accepting CE Mark. Conor is currently conducting a
U.S. pivotal clinical trial, COSTAR II, to support its application
for U.S. regulatory approval of the CoStar stent. Additional
programs are underway to explore the utilization of other compounds
for the treatment of restenosis and other vascular diseases. CoStar
is not available for sale in the United States. CoStar is an
investigational device limited by law to investigational use. About
Conor Medsystems Conor Medsystems, Inc. is developing and
commercializing a pipeline of innovative controlled vascular drug
delivery technologies and products with an initial focus on the
development of drug-eluting stents to treat coronary artery
disease. For further information on Conor Medsystems and controlled
vascular delivery, visit http://www.conormed.com/. This press
release contains certain forward-looking statements that involve
risks and uncertainties, including without limitation, the
statements related to clinical development of the company's
drug-eluting stent platform and potential regulatory approval of
the company's CoStar stent. All forward- looking statements and
other information included in this press release are based on
information available to Conor Medsystems as of the date hereof,
and the company assumes no obligation to update any such
forward-looking statements or information. The company's actual
results could differ materially from those described in the
company's forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to,
those discussed in detail under the heading "Risk Factors" in the
company's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2005 filed with the SEC on November 14, 2005,
including (i) risks related to the uncertain, lengthy and expensive
clinical development and regulatory process, including, among other
things, (a) the risk that clinical results reported to date may not
be indicative of future clinical results, (b) the risk that a
clinical trial, including the COSTAR II trial, may not be completed
on schedule, or at all, including as a result of patients
experiencing adverse side effects or events related to the
company's stents, which could result in substantial delays and a
redesign of the trial, (c) the risk that issues in the company's
manufacturing processes could delay or impede the company's
clinical development plans, (d) the risk that the third parties on
whom the company relies to conduct its clinical trials may not
perform as contractually required or expected, and (e) risks
related to regulation by the FDA and foreign regulatory authorities
and the company's limited experience in regulatory affairs,
including the risk that that the company may never obtain FDA and
equivalent foreign market approvals, including approval to market
our CoStar stent in the United States; and (ii) risks related to
patent infringement, including, among other things, (a) the risk
that if any patent infringement claims or other intellectual
property claims against the company are successful, the company
may, among other things (1) be enjoined from, or required to cease,
the development, manufacture, use and sale of products that
infringe the patent rights of others, (2) be required to expend
significant resources to redesign its technology so that it does
not infringe others' patent rights, which may not be possible,
and/or (3) be required to obtain licenses to the infringed
intellectual property, which may not be available to the company on
acceptable terms, or at all, and (b) the risk that intellectual
property litigation against the company could significantly disrupt
the company's development and commercialization efforts, divert
management's attention and quickly consume the company's financial
resources. The risks and other factors discussed above should be
considered only in connection with the fully discussed risks and
other factors discussed in detail in the company's periodic reports
filed with the SEC, including the company's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2005. DATASOURCE:
Conor Medsystems, Inc. CONTACT: investors, Michael Boennighausen,
Chief Financial Officer of Conor Medsystems, Inc., +1-650-614-4100;
or media, Karen L. Bergman of BCC Partners, +1-650-575-1509; or Nan
Foster, +1-415-307-6955, both for Conor Medsystems, Inc. Web site:
http://www.conormed.com/
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