Healthcare Industry News: COSTAR II
News Release - March 16, 2006
Conor Medsystems Licenses Pimecrolimus From Novartis for Use in Next-Generation Reservoir-Based Drug-Eluting StentsMENLO PARK, Calif., March 16 (HSMN NewsFeed) -- 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 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.
Source: Conor Medsystems
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