Lonza - Imclone Systems Incorporated and LonBiologics enter into a supply agreement for manufacturing of IMC-C225 |
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09/07/2000
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| Basel - ImClone Systems Incorporated (Nasdaq: IMCL) and Lonza Biologics, a subsidiary of Lonza Group Ltd Switzerland, announced today that the companies have entered into an agreement for Lonza Biologics to be a second source manufacturer of ImClone Systems' lead targeted cancer therapeutic IMC-C225. |
ImClone Systems Incorporated (Nasdaq: IMCL) and Lonza Biologics, a subsidiary of Lonza Group Ltd Switzerland, announced today that the companies have entered into an agreement for Lonza Biologics to be a second source manufacturer of ImClone Systems' lead targeted cancer therapeutic IMC-C225. ImClone Systems is currently constructing its new commercial-scale manufacturing facility in Somerville, New Jersey, for production of IMC-C225. ImClone Systems' IMC-C225 is a monoclonal antibody that is designed to target and block the Epidermal Growth Factor receptor (EGFr), which is associated with tumor cell growth and repair in a number of solid tumors.
"We are confident that Lonza Biologics, an industry leader in antibody manufacturing, will be able to meet our production and quality goals and timetables as a supplemental supplier of IMC-C225," stated Samuel D. Waksal, Ph.D., President and Chief Executive Officer of ImClone Systems. "This agreement is a major step toward helping to ensure that IMC-C225 will be available to oncologists and their patients once FDA approval is obtained. The antibody supply we have contracted for from Lonza will help support our ongoing clinical development program with IMC-C225, as well as our potential commercial needs."
"This agreement represents an excellent opportunity for Lonza Biologics to support delivering an important new cancer therapeutic to patients in need of treatment alternatives," stated Larry Thomas, V.P., Sales and Marketing of Lonza Biologics. "In addition, this agreement and its scope of activity further underscores the importance of Lonza Biologics within the Lonza Group organization. Providing biological products for the lifescience industry is of key strategic importance to Lonza Group and significant investment in this sector will continue to grow."
ImClone Systems is developing IMC-C225 for use in multiple cancer indications. The Company's initial commercialization effort is for the treatment of patients with refractory colorectal carcinoma. Preliminary clinical findings indicate that the combination of IMC-C225 and irinotecan, a chemotherapeutic agent, can produce responses in patients that have either failed or not responded to prior treatment with irinotecan. The Company is currently conducting a Phase II study evaluating IMC-C225 in combination with irinotecan in patients with refractory colorectal carcinoma.
ImClone Systems is also conducting a Phase II study evaluating IMC-C225 in combination with cisplatin in patients with refractory advanced squamous cell head and neck carcinoma and a Phase II study evaluating IMC-C225 in combination with gemcitabine in patients with pancreatic carcinoma. In addition to the Phase II program, the Company is conducting two Phase III clinical trials evaluating IMC-C225 in combination with radiotherapy and with chemotherapy respectively in patients with advanced squamous cell head and neck carcinoma.
ImClone Systems Incorporated is 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 City with manu-facturing facilities in Somerville, New Jersey.
Lonza Biologics is a subsidiary of Lonza Group and is the world's leader in contract development and production of therapeutic antibodies and proteins. The company undertakes highly specialized services for the pharmaceutical and biotechnology industries based on its nearly 20 years of experience in mammalian cell culture and on proprietary technology for the large scale manufacture of innovative pharmaceutical products. With headquarters in the United Kingdom, Lonza Biologics operates cGMP multi-product manufacturing facilities in Slough, United Kingdom and Portsmouth, New Hampshire.
Lonza Group is a specialty chemicals company headquartered in Switzerland, with sales of CHF 2.2 billion in 1999 and operating 20 facilities in 8 countries. It employs 5,600 people worldwide and is the leading supplier of active chemical intermediates and biotechnology solutions to the pharmaceutical and agrochemical industries. It also offers a broad catalogue of organic intermediates for a wide range of applications such as pharmaceuticals, agrochemicals, vitamins, food and feedstuff, dyes and pigments, adhesives and fragrances as well as polymers and plastics. Furthermore the Group manufactures specialty biocides and oleochemicals.
ImClone Systems' IMC-C225 is an investigational drug currently being evaluated in clinical trials. The determination of the safety and effectiveness of this product is subject to evaluation by the U.S. Food and Drug Administration (FDA). FDA has not reviewed or determined that the information on IMC-C225 is sufficient for approval.
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.
For further information please contact:
Dr. Walter Eschenmoser
Tel + +41 61 316 8363
Fax + +41 61 316 8220
walter.eschenmoser@lonzagroup.com
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