European Regulatory Committee Recommends Orphan Drug Status for GPC Biotech's Anticancer Monoclonal Antibody 1D09C3 for Multiple Myeloma GPC Biotech AG
(Press Release) Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., February 14, 2006 GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has recommended the granting of orphan medicinal product designation for the anticancer monoclonal antibody 1D09C3 for the treatment of multiple myeloma. The orphan drug status becomes effective when the European Commission has approved this recommendation. 1D09C3 is currently in a Phase 1 clinical program that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, including Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy. The orphan drug program of the EMEA is designed to promote the development of drugs to treat life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union (EU). The designation provides EU market exclusivity for up to ten years in the given indication. Other potential benefits include: a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval, and EMEA guidance in preparing a dossier for marketing approval. 1D09C3 was previously granted orphan medicinal product designation by the European Commission for Hodgkin's lymphoma and chronic lymphocytic leukemia, a type of non-Hodgkin's lymphoma. About 1D09C3 1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to MHC class II molecules on the cell surface and in preclinical studies appears to selectively kill activated, proliferating tumor cells, which include B-cell and T- cell lymphomas. In 2004, it was estimated that more than 54,000 people in the U.S. and about 64,000 people in the EU were newly diagnosed with non-Hodgkin's lymphoma, the most common form of lymphoma. Multiple myeloma is an aggressive type of non-Hodgkin's lymphoma and currently affects approximately 67,000 people in the EU. In preclinical studies, 1D09C3 has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect. A Phase 1 clinical program evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy, is currently underway at several major cancer centers in Europe. 1D09C3 has been granted orphan medicinal product designation for the treatment of Hodgkin's lymphoma and chronic lymphocytic leukemia. Additional information on 1D09C3 can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com. GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company's lead product candidate satraplatin has achieved target enrollment in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and GPC Biotech has begun the rolling NDA submission process for this compound. GPC biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company's Web site at www.gpc-biotech.com. *** This press release may contain projections or estimates about plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements. These statements are forward- looking and are subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company's relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. There can be no guarantee that the Phase 1 trials with 1D09C3 will be successfully completed nor that 1D09C3 will be approved for marketing in a timely manner, if at all. 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