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ImClone (IMCL) Issues Statement Regarding Swissmedic Pre-Notification Of Marketing Authorization For ERBITUX(TM)


10/19/2005 5:10:46 PM

NEW YORK--(BUSINESS WIRE)--Nov. 13, 2003--ImClone Systems Incorporated (NASDAQ: IMCL - News) today issued the following statement regarding the decision by Swissmedic, the Swiss agency for therapeutic products, to pre-notify Merck KGaA of its intent to authorize the marketing of ERBITUX(TM) in Switzerland:

"We are pleased that our partner Merck KGaA has received pre-notification of Swissmedic's intent to authorize marketing of ERBITUX in Switzerland. As Merck KGaA stated, the final approval is expected within thirty days. Once approved, doctors in Switzerland will be able to administer ERBITUX in combination with the standard chemotherapy irinotecan. Today's action by Swissmedic is a significant achievement for ImClone Systems in our continuing effort to bring ERBITUX to patients with cancer."

About ERBITUX (cetuximab)

ERBITUX is an investigational IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. ERBITUX is designed to bind to EGFR and prevent natural ligands called growth factors from binding to the receptor and inducing phosphorylation, i.e., activation of signaling to the tumor. ERBITUX is also being studied in second-line colorectal cancer, and other types of cancer that express the EGF receptor, including lung, pancreatic, ovarian and head and neck cancers. The most common adverse events reported in clinical trials of ERBITUX have been an acne-like rash, asthenia, diarrhea, nausea, abdominal pain and vomiting. Severe allergic reactions were observed in a small percentage of patients. Additional information about ERBITUX can be found at www.cetuximab.com.

About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers. The Company's three programs include growth factor blockers, cancer vaccines and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems is headquartered in New York with manufacturing facilities in Branchburg, New Jersey.

The matters discussed in this news release may include forward-looking statements which involve potential risks and uncertainties. Important factors that may cause actual results to differ materially include, but are not limited to, the risks and uncertainties associated with completing pre-clinical and clinical trials of the company's compounds that demonstrate such compounds' safety and effectiveness; manufacturing losses and risks associated therewith; obtaining additional financing to support the company's operations; obtaining and maintaining regulatory approval for such compounds and complying with other governmental regulations applicable to the company's business; obtaining the raw materials necessary in the development of such compounds; consummating and maintaining collaborative arrangements with corporate partners for product development; achieving milestones under collaborative arrangements with corporate partners; developing the capacity to manufacture, market and sell the company's products, either directly or with collaborative partners; developing market demand for and acceptance of such products; competing effectively with other pharmaceutical and biotechnological products; obtaining adequate reimbursement from third party payers; attracting and retaining key personnel; legal costs and the outcome of outstanding legal proceedings and investigations including but not limited to our investigations pertaining to withholding tax issues; complying with covenants in the indenture for the company's Convertible Subordinated Notes and with the terms of other contractual obligations; obtaining patent protection for discoveries and risks associated with commercial limitations imposed by patents owned or controlled by third parties. The company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

ImClone Systems Incorporated Investors: Andrea F. Rabney, 646-638-5058 or

Media: Jason E. Farber, 646-638-5063 or

The Abernathy MacGregor Group Andrew Merrill or David Pitts, 212-371-5999

Source: ImClone Systems Incorporated


Read at BioSpace.com


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