GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin
Martinsried/Munich (Germany), Waltham, Mass. and Princeton, N.J., February 16, 2007 – GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that the Company has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for satraplatin for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) who have failed prior chemotherapy. The Company submitted the third and final portion of the NDA - the clinical section, which is based primarily on data from the SPARC Phase 3 registrational trial. The trial enrolled 950 patients and showed highly statistically significant results for prolonging progression-free survival (PFS). The FDA has up to 60 days to determine whether the application meets the regulatory requirements for filing and thus will be reviewed by the agency. The Company will also be notified during that timeframe if priority review status has been granted.
“The submission of the NDA for satraplatin capsules is a major milestone in the corporate history of GPC Biotech,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “We will work closely with the FDA during the review process to move the application forward as expeditiously as possible. We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope. We are currently building our commercial infrastructure in the U.S. to prepare for the potential launch of satraplatin so that it will be available for these patients as quickly as possible.”
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones – or “hormone-refractory” – and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for hormone-refractory prostate cancer. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed.
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.
In September 2006, GPC Biotech announced positive topline results from the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. The study data show that the results for PFS are highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S. and will also serve as the primary basis for a Marketing Authorization Application (MAA) in Europe. The Company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
The most common adverse reactions in the SPARC trial consisted of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count); gastrointestinal events, such as nausea, constipation and diarrhea; and fatigue. These adverse reactions were mostly mild to moderate in severity. No significant degradation of renal function or worsening of neuropathy was noted.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company’s Web site at www.gpc-biotech.com.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech’s lead product candidate – satraplatin – is an oral platinum-based compound that has shown highly statistically significant results for progression-free survival 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 the rolling NDA submission process for this compound has been completed. 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), and its wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit GPC Biotech’s Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG, including summary statements relating to results of the SPARC trial and summary statements relating to the potential efficacy and safety profile of satraplatin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. In particular, additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. We cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech does not undertake any obligation to update these forward-looking statements, even if new information becomes available in the future.
The scientific information discussed in this press release related to satraplatin is preliminary and investigative. Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
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- GPC Biotech AG
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