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FDA Grants Fast Track Designation for Anticancer Drug Candidate Satraplatin

MARTINSRIED/MUNICH, GERMANY and U.S. Research Facilities in WALTHAM/BOSTON, MA and PRINCETON, NJ -- September 22, 2003 -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30) today announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" designation to satraplatin as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC).

The FDA's fast track programs are intended to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The "fast track" designation enables a company to do a rolling submission, submitting sections of the NDA (New Drug Application) as they become available.

A multicenter, global, randomized study evaluating satraplatin plus prednisone versus prednisone alone as a second-line chemotherapy regimen for treating patients with HRPC is expected to begin soon. The primary endpoint of the trial will be the time to disease progression. The study's objectives also will include the evaluation of pain control and survival, as well as an assessment of drug safety in this patient population.

"The receipt of fast track designation from the FDA represents another important step forward in our strategy to advance satraplatin through the clinical/regulatory process as rapidly as possible," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech. "This fast track designation recognizes the need for new, efficacious therapies in treating hormone-refractory prostate cancer patients who have failed one chemotherapeutic regimen. We will continue to work closely with the FDA throughout the trial process."

Prostate cancer is the most common cancer among men in the U.S. Over 220,000 new cases are projected for 2003, and an estimated one in six men is expected to develop prostate cancer in his lifetime. An estimated 100,000 patients in North America, Europe and Japan combined have hormone-refractory prostate cancer. For those patients failing hormone therapy, treatment currently involves a limited number of options, including chemotherapy. These options are usually only marginally effective. For those patients who fail first-line chemotherapy, there are currently no approved treatment regimens.

About Satraplatin

Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered. Satraplatin has successfully completed the Special Protocol Assessment (SPA) process with the FDA and is expected to enter a Phase 3 registrational study in HRPC in the near future. Positive results from a randomized, 50-patient study in HRPC were presented at the ASCO Annual Meeting in June 2003. These data demonstrated statistical significance in time to disease progression, doubling progression-free survival in the satraplatin- treated group versus the control group. Additionally, Phase 2 trials have been successfully completed in HRPC, as well as in other tumor types, including ovarian and small-cell lung cancer. Further information on satraplatin can be found in the Drug Discovery and Development section of the Company's Web site at http://www.gpc-biotech.com.


SOURCE: GPC Biotech AG

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