ImClone Systems Incorporated Announces Decision by The FDA Not To Accept For Filing The ERBITUX Biologics License Application

Business Wire, Dec 28, 2001

Health/Medical Writers

NEW YORK--(BW HealthWire)--Dec. 28, 2001

ImClone Systems Incorporated (Nasdaq: IMCL) announced today that the U.S. Food and Drug Administration (FDA) has advised the Company that at this time it is not accepting for filing in its current form the Company's rolling Biologics License Application (BLA) for ERBITUX(TM). The BLA was submitted for marketing approval to treat irinotecan-refractory colorectal carcinoma. In accordance with application regulations, the FDA is required to accept or refuse an application within 60 days of the completion of the filing, which occurred on October 31, 2001. Neither the acceptance nor non-acceptance of the BLA filing is a determination of the approvability of ERBITUX.

The Company intends to meet with the FDA as soon as possible to discuss the requests for additional information made by the Agency in order for the filing to be accepted. Following its meeting with the FDA, the Company will be able to better assess the timing for addressing the Agency's issues in order to move the application process forward quickly.

"We will be working closely with the FDA toward the goal of an expeditious acceptance of our BLA," stated Samuel D. Waksal, Ph.D., President and Chief Executive Officer of ImClone Systems Incorporated. "Our goal is to get ERBITUX FDA-approved as soon as possible so that it is accessible to patients suffering from this serious form of cancer."

ERBITUX is an investigational monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells. The FDA is reviewing ERBITUX for the treatment of colorectal cancer.

In February 2001, the FDA granted ImClone Systems Fast Track designation for ERBITUX(TM) in the treatment of irinotecan-refractory colorectal cancer. Under the FDA Modernization Act of 1997, Fast Track designation facilitates the development and expedites the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition. The Agency's Guidelines for Industry Fast Track Development Programs require that a clinical development program must continue to meet the criteria for Fast Track designation for an application to be reviewed under the Fast Track Program.

ImClone Systems is studying ERBITUX(TM) in a series of Phase II and Phase III clinical trials. The Company is conducting Phase II clinical studies of ERBITUX in combination with standard therapies in patients with various stages of colorectal cancer, pancreatic cancer, head and neck cancer, and non-small cell lung cancer. In addition to the Phase II studies, the Company is conducting a Phase III clinical trial combining ERBITUX with chemotherapy and another study combining ERBITUX with radiotherapy as first-line treatments for head and neck cancer. The most common drug-related adverse events reported in clinical trials of ERBITUX has been an acne-like rash. Severe allergic reactions may occur in a small percentage of patients.

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 Somerville, 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; 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 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; 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.