GPC Biotech Schedules Conference Call on July 25 to Discuss Oncologic
Drugs Advisory Commi
* ODAC briefing documents now available online on FDA website
Martinsried/Munich (Germany), Princeton, N.J., July 20, 2007 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that the Company will hold a conference call on July 25, 2007 at 7:00 AM CET/1:00 AM ET to discuss the recommendation of the Oncologic Drugs Advisory Committee (ODAC) relating to satraplatin for the treatment of patients with hormone-refractory prostate cancer whose disease has progressed after prior chemotherapy. The ODAC meeting will be held on Tuesday, July 24, 2007 and its outcome will be published in advance of the conference call.
The Company also announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the ODAC meeting. Documents posted on the FDA website include briefs submitted by GPC Biotech and the FDA. The briefing documents can be accessed at http://www.fda.gov/ohrms/dockets/ac/cder07.htm#OncologicDrugs
Dial-in information for GPC Biotech conference call on July 25th Participants may listen to the Company's conference call via live webcast, accessible through the GPC Biotech Web site at www.gpc-biotech.com or via telephone. A replay will be available on the Web site following the live event. The call, which will be conducted in English, will be held on July 25, 2007 at 7:00 AM CET/1:00 AM ET, prior to the opening of the German markets. The dial-in numbers for the call are as follows:
Participants from Europe: +49 (0)89 9982 99910 or +44 (0)20 7806 1950 Participants from the U.S.: 1-718-354-1385
Please dial in 10 minutes before the beginning of the call.
About GPC Biotech 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 currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. 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 has a wholly owned U.S. subsidiary headquartered in 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 statements about the status of the FDA review process. 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, there can be no guarantee that 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. Furthermore, 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, 2006 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 undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
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.
The ODAC will report to the FDA and make recommendations and we expect the report of the ODAC to the FDA on satraplatin to be an important element in the FDA's review of our NDA. However, views of the ODAC may differ from those of the FDA and there can be no guarantee that the FDA will follow the ODAC's recommendations.
For further information, please contact:
GPC Biotech AG Martin Braendle Director, Investor Relations & Corporate Communications Phone: +49 (0)89 8565-2693 firstname.lastname@example.org
In the U.S.: Laurie Doyle Director, Investor Relations & Corporate Communications Phone: +1 609 524 5884 email@example.com
Additional Media Contacts:
In Europe: Maitland Brian Hudspith Phone: +44 (0)20 7379 5151 firstname.lastname@example.org
In the U.S.: Russo Partners, LLC David Schull Phone: +1 212 845 4271 email@example.com
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GPC Biotech AG Fraunhoferstr. 20 Martinsried
WKN: 585150; ISIN: DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX, HDAX, TECH All Share; Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin Bremen, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Geregelter Markt in Frankfurter Wertpapierbörse;