Orphan Drug Designation Granted by European Commission for Anticancer Monoclonal Antibody 1D09C3 for Chronic Lymphocytic Leukemia
Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., January 27, 2006 – GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that the European Commission has granted orphan drug designation for the anticancer monoclonal antibody 1D09C3 for the treatment of chronic lymphocytic leukemia (CLL). 1D09C3 is currently in a Phase 1 clinical trial that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, such as Hodgkin’s and non-Hodgkin’s lymphomas including CLL, who have failed prior standard therapy.
The orphan drug program of the European Medicines Agency (EMEA) is designed to promote the development of drugs to treat rare 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 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody. 1D09C3 binds to MHC class II molecules on the cell surface and selectively kills 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 European Union were diagnosed with non-Hodgkin’s lymphoma, the most common form of lymphoma. CLL is considered a sub-type of non-Hodgkin’s lymphoma and is the most common form of adult leukemia in the Western world. 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, such as Hodgkin’s and non-Hodgkin’s lymphomas including CLL, who have failed prior standard therapy is currently underway at major cancer centers in Europe. 1D09C3 has also been granted orphan medicinal product designation for the treatment of Hodgkin’s lymphoma. 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. We direct you to the Company’s Annual Report on Form 20-F, as amended, for the fiscal year ended December 31, 2004 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the Company’s future results, performance and achievements. The Company disclaims any intent or obligation to update these forward-looking statements or the factors that may affect the Company’s future results, performance or achievements, even if new information becomes available in the future.
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