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GPC BIOTECH GETS GERMANY PERMITS FOR MONOCLONAL ANTIBODY.

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30) has received three important permits from the responsible German regulatory agency for the company's fully human oncology monoclonal antibody, 1D09C3. First, the company has received a permit certifying that the antibody drug substance was manufactured according to the GMP (Good Manufacturing Practice) rules of the European Union (EU). This certificate was issued after the U.S. manufacturer successfully passed a GMP inspection by the German regulatory agency. Second, the agency has granted a permit allowing the importation of the antibody drug substance into the EU. Third, GPC Biotech has received a manufacturing permit allowing the company to store and label the antibody drug substance. These three permits are a pre-requisite for initiating clinical trials in the EU. Clinical trials are expected to begin in the second half of 2004.

At the beginning of August, GPC Biotech provided an update on the development of 1D09C3. The company reported a number of significant achievements for this program, including: 1) consistent in vivo efficacy results in various lymphoid tumor animal models; 2) production of sufficient quantities of GMP-quality material for Phase 1/2 clinical trials; and 3) identification of an appropriate administration schedule.

About 1D09C3

GPC Biotech is developing a fully human anti-MHC class II monoclonal antibody, 1D09C3. This antibody binds to certain cell surface receptors, the so-called MHC (major histocompatibility complex) class II molecules, killing activated, proliferating MHC class II positive tumor cells, including B-cell- and T-cell-lymphomas and others. Normal, resting cells are not similarly killed. The antibody has been shown to induce programmed cell death. Cell death occurs rapidly via a novel mechanism-of-action that does not require a fully functioning immune system. Since most patients with these types of tumors are immunocompromised as a result of prior chemotherapy or the disease itself, this is potentially a significant advantage over most antibodies targeting B-cell lymphomas. This antibody was isolated by MorphoSys AG from its HuCAL(R) library of fully human antibodies and has a very high binding affinity to its MHC class II target.

GPC Biotech AG is a biotechnology company dedicated to discovering and developing new anticancer drugs through innovative discovery technologies and development approaches. The company's lead product candidate - satraplatin - has successfully completed Phase II clinical trials and is expected to enter a Phase III registrational study during 2003. The company is leveraging its drug discovery technologies in novel ways to elucidate the mechanisms-of- action of drug candidates and to support the growth of its drug pipeline. The company has formed successful collaborations with a number of pharmaceutical firms, including ALTANA Pharma of ALTANA AG (FSE: ALT; NYSE: AAA), Aventis Pharma (PAVE.PSE), Bayer AG (FSE: BAY; NYSE: BAY), Boehringer Ingelheim International GmbH, Eli Lilly and company (NYSE:LLY) and Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) . GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The company's wholly owned U.S. subsidiary has research sites in Waltham, Massachusetts and Princeton, New Jersey.

For more information, visit http://www.gpc-biotech.com or call 781/890-9007 ext. 267.
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Publication:Worldwide Biotech
Geographic Code:4EUGE
Date:Oct 1, 2003
Words:504
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