Thursday, February 16, 2006

European Regulatory Committee Recommends Orphan Drug Status

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. 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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