ImClone, Lonza enter manufacturing supply agreement

Lonza to become a second source for cancer therapeutic

ImClone Systems Inc. (New York, NY) and Lonza Biologics (Portsmouth, NH), a subsidiary of Lonza Group Ltd. of Switzerland, have entered into an agreement whereby Lonza will become a second source manufacturer of ImClone Systems' lead targeted cancer therapeutic, IMC-C225. ImClone is currently building a new commercial-scale manufacturing facility in Somerville, New Jersey, for producing IMC-C225, a monoclonal antibody that blocks epidermal growth factor receptor (EGFr), which is associated with tumor cell growth and repair in solid tumors.

Said Samuel D. Waksal, president and CEO of ImClone Systems, "This agreement is a major step towards ensuring 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."

The agreement represents an opportunity for Lonza to support the delivery of an important new drug for an important indication. According to Larry Thomas, Lonza Biologics' VP of marketing, the deal underscores the importance of his division within the Lonza group. "Providing biological products for the life science 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. Initial commercialization efforts are targeted towards patients with refractory colorectal cancer. 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. ImClone is conducting a Phase II study evaluating IMC-C225 combined with irinotecan in patients with refractory colorectal carcinoma.

ImClone is also conducting a Phase II study evaluating IMC-C225 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. Two Phase II trials are underway evaluating IMC-C225 plus radiotherapy or with chemotherapy in patients with advanced squamous cell head and neck carcinoma.

For more information: Andrea F. Rabney, ImClone Systems Inc., 180 Varick St., New York, NY 10014. Tel: 646-638-5058. Walter Eschenmoser, Lonza Group Ltd., Feldeggstrasse 4, CH-8034 Zurich, Switzerland. Tel: +41-61-316-8363. Fax: +41-61-316-8220.

Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online