ImClone Systems Announces the Early Achievement of $5 Million Clinical Milestone in IMC-C225 Agreement With Merck KGaA.Business Editors/Health & Medical Writers NEW YORK--(BW HealthWire)--May 31, 2001 ImClone Systems Incorporated (Nasdaq:IMCL IMCL International Making Cities Livable IMCL Inter Marine Container Lines IMCL International Management Consultants Ltd. IMCL Indraprastha Medical Corp Ltd (India) IMCL Imperial Majesty Cruise Line ) announced today the early achievement of a clinical development milestone under its agreement with Merck KGaA for the rights to develop and market IMC-C225 outside of North America. The milestone, which triggers a $5 million equity-based payment, relates to the presentation by ImClone Systems of data from its Phase II clinical study of IMC-C225 in combination with irinotecan in patients with irinotecan-refractory colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. and Merck KGaA's confirmation that this data will enable them to further develop IMC-C225 in Europe. IMC-C225 is an investigational monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing designed to target and block the Epidermal Growth Factor Receptor This article is about a cell suface receptor. For estimated measure of kidney function (eGFR), see Glomerular filtration rate. The epidermal growth factor receptor (EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme) EGFR Estimated Glomerular Filtration Rate ), which is expressed on the surface of certain cancer cells. Under the terms of the agreement, Merck KGaA will be issued approximately 63,000 shares of ImClone Systems common stock at a price of $79.33 per share, which represents the 30 day average closing price of the stock on the day the milestone was achieved, plus a 50 percent premium based on the achievement being earlier than specified in the agreement. "The early achievement of this milestone exemplifies the strength of our Phase II data in refractory colorectal cancer and our well managed IMC-C225 clinical trials program," stated Samuel D. Waksal Samuel D. Waksal, who was born September 8, 1947 in Paris, France to Holocaust survivor parents, is an Jewish American immunologist and businessman, who founded the biopharmaceutical company ImClone Systems in 1984. He also served as ImClone's CEO. , Ph.D., President and Chief Executive Officer of ImClone Systems. "Our Phase II data will be added to the information Merck KGaA uses to gain permission for the initiation of new clinical trials of IMC-C225 in Europe, including a Phase II study in patients with refractory colorectal cancer." ImClone Systems is studying IMC-C225 in a series of Phase II and Phase III clinical trials. The Company is conducting Phase II clinical studies of IMC-C225 in combination with standard therapies in patients with various stages of colorectal cancer, pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. , head and neck cancer, and non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . In addition to the Phase II studies, the Company is conducting a Phase III clinical trial combining IMC-C225 with chemotherapy and another study combining IMC-C225 with radiotherapy as first line treatments for head and neck cancer. Under the terms of a 1998 agreement, Merck KGaA has been granted a license from the Company to rights to IMC-C225 outside of North America, with the exception of Japan, where the companies will co-develop the drug. 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 Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine 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 Somerville is a borough in Somerset County, New Jersey, United States. As of the United States 2000 Census, the borough population was 12,423. It is the county seat of Somerset CountyGR6. . 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion