To: If only I'd held who wrote (100045 ) 4/25/2000 8:54:00 AM From: manny t Respond to of 108040
IMCL, ImClone Systems Receives Notice of Allowability of U.S. Patent for TherapeuticCombination of Anti-EGF Receptor Monoclonal Antibodies and Anti-NeoplasticAgents Tue Apr 25 06:46:00 EDT 2000 NEW YORK, Apr 25, 2000 (BUSINESS WIRE) -- ImClone Systems Incorporated (Nasdaq:IMCL) announced today it has received notification from the United States Patent and Trademark Office of the allowability of a patent claiming the therapeutic combination of anti-Epidermal Growth Factor receptor (EGFr) monoclonal antibodies and anti-neoplastic agents, for use in the treatment of cancer. ImClone Systems' lead targeted cancer therapeutic, IMC-C225, is a monoclonal antibody that inhibits EGFr and is currently being tested in late stage pivotal studies. The patent will cover a composition of matter of any EGFr monoclonal antibody which inhibits the binding of EGF to its receptor, in combination with any anti-neoplastic agent, as well as the therapeutic use of such combinations. "This patent will solidify ImClone Systems' position as the leader in the development of monoclonal antibodies which inhibit EGFr," stated Samuel D. Waksal, Ph.D., President and Chief Executive Officer of ImClone Systems Incorporated. "This patent along with others in our intellectual property portfolio will provide ImClone with a distinct advantage in the development and commercialization of our lead product candidate, IMC-C225." IMC-C225, ImClone Systems' lead biologic cancer therapeutic, is being developed to target and treat cancers that are positive for the Epidermal Growth Factor receptor (EGFr), associated with tumor cell growth and repair in a number of solid tumor cancers. The Company is conducting two Phase III clinical trials evaluating IMC-C225 in combination with radiotherapy and with chemotherapy in patients with advanced squamous cell head and neck carcinoma. In addition to the Phase III studies, ImClone Systems is conducting a Phase II trial evaluating IMC-C225 in combination with cisplatin in patients with refractory advanced squamous cell head and neck carcinoma. ImClone Systems is testing IMC-C225 in other indications as well. The Company is conducting a Phase II trial evaluating IMC-C225 in combination with irinotecan in patients with refractory colorectal carcinoma and, a Phase II study evaluating IMC-C225 in combination with the anti-cancer agent gemcitabine in patients with pancreatic carcinoma. ImClone Systems Incorporated is advancing oncology care by developing a portfolio of targeted biologic treatments, which address the medical needs of patients with a variety of cancers. The Company's three programs include growth factor blockers, cancer vaccines and anti-angiogenesis therapeutics. 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 City with manufacturing facilities in Somerville, New Jersey. Except for the historical information contained herein, the matters discussed in this news release may include forward-looking statements. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company's business, including, without limitation, risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, and the Company's ability to obtain additional financing to support its operations. The Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Distributed via COMTEX. Copyright (C) 2000 Business Wire. All rights reserved