[MOL] FDA grants orphan drug designation to pentace for sclc..... [01856] Medicine On Line

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[MOL] FDA grants orphan drug designation to pentace for sclc.....

FDA Grants Orphan Drug Designation To Pentacea For Small Cell Lung Cancer

MORRIS PLAINS, N.J. -- March 9, 2000 -- IBC Pharmaceuticals, LLC, a joint venture between Immunomedics, Inc. and Beckman Coulter Corporation announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted orphan drug designation for its lead product, Pentacea(TM), for the treatment of small cell lung cancer (SCLC). In addition to certain tax benefits, orphan drug designation provides U.S. marketing exclusivity for seven years following the drug's marketing approval.

SCLC is the most aggressive form of lung cancer and there is currently no effective therapy. The majority of these patients succumb to their disease within 12-18 months. Pentacea(TM) is currently in Phase I/II clinical trials for the treatment of small cell lung cancer and is the first commercial drug to be developed using the Company's proprietary platform technology based on 2-step bispecific antibody pretargeting.

With Pentacea(TM), patients first receive an injection of bispecific antibody. One arm of the bispecific antibody binds to the patient's tumor. After allowing time for tumor targeting and clearance of unbound bispecific antibody from the body, the radiation attached to its carrier, is injected. The carrier with the radiation binds to the other half of the bispecific antibody, allowing for specific and high tumor uptake. Radiation that does not bind to pretargeted bispecific antibody is rapidly eliminated from the body, thus limiting the patient's exposure to radiation and allowing high doses to be administered.

The Company's Executive Vice President, Dr. John Reno, remarked: "We are excited about the prospects of this latest method of selective delivery of radiation for cancer therapy, since it holds promise for repeated therapies without evoking major immune responses. Our first products using this technology showed excellent therapeutic results in preclinical studies, as well as encouraging therapeutic responses in patients with small-cell lung cancer."

IBC Pharmaceuticals is developing radiopharmaceutical products for the treatment of cancer based on its proprietary pretargeting technology. Pentacea(TM) binds to CEA positive tumors. CEA is expressed on most of the major solid tumors including those of the colon, breast and lung.

Related Links: IBC Pharmaceuticals, Immunomedics, Inc. and Beckman Coulter Corporation.

Warmly, lillian

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