GPC Biotech Withdraws Satraplatin NDA For Accelerated Approval; Plans to Resubmit With Survival Analysis
July 30 2007 - 9:48AM
PR Newswire (US)
IRVINE, Calif., July 30 /PRNewswire-FirstCall/ -- Spectrum
Pharmaceuticals, Inc., (NASDAQ:SPPI) today announced that GPC
Biotech has withdrawn the satraplatin New Drug Application (NDA)
filed for accelerated approval for the treatment of
hormone-refractory prostate cancer. The decision was based on the
vote by the Oncologic Drugs Advisory Committee (ODAC) to the U.S.
Food and Drug Administration (FDA) on July 24, 2007 that the FDA
should wait for the survival analysis of the SPARC trial before
deciding whether satraplatin is approvable. GPC Biotech anticipates
overall survival results from the SPARC trial to be available
within six months. However, this timing is based on an
extrapolation of death rates in the trial and may change. "We look
forward to receiving the overall survival data from the SPARC trial
and to the resubmission of the NDA to the FDA next year," stated
Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum
Pharmaceuticals. "Meanwhile, we plan to aggressively continue the
development of Spectrum's diversified pipeline, including,
EOquin(R) in Phase 3 clinical trials for non- invasive bladder
cancer, and ozarelix in a Phase 2b trial for benign prostate
hypertrophy, as we strive to reduce risk and build value for our
shareholders by not depending on the success of any single drug or
technology." Spectrum acquired worldwide rights to satraplatin from
Johnson Matthey PLC. In 2002, Spectrum licensed worldwide rights to
satraplatin to GPC Biotech (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB). GPC Biotech is responsible for all costs
associated with the development and regulatory filings of
satraplatin. About Spectrum Pharmaceuticals Spectrum
Pharmaceuticals acquires, develops and commercializes a diversified
portfolio of oncology drug candidates that meet critical health
challenges for which there are few other treatment options.
Spectrum's expertise lies in identifying drugs with demonstrated
safety and efficacy, and adding value through further clinical
development and selection of the most efficient methods of
commercialization. The company's pipeline includes promising early
and late-stage drug candidates with unique formulations and
mechanisms of action that address the needs of seriously ill
patients, such as at-home chemotherapy and new treatment regimens
for refractory disease. For more information, please visit our
website at http://www.spectrumpharm.com/. Forward-looking statement
- This press release may contain forward-looking statements
regarding future events and the future performance of Spectrum
Pharmaceuticals that involve risks and uncertainties that could
cause actual results to differ materially. These statements include
but are not limited to statements that relate to our business and
its future, Spectrum's ability to identify, acquire, develop and
commercialize its portfolio of drug candidates, the Company's
promising pipeline, our team's ability to identify promising drugs
and move these drugs through development and toward
commercialization, that survival results from the SPARC trial will
be available within six months, that the satraplatin NDA will be
resubmitted to the FDA next year, that we will aggressively
continue the development of our diversified pipeline, that we will
reduce risk and build value for our shareholders and any statements
that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of
historical fact. Risks that could cause actual results to differ
include the possibility that our existing and new drug candidates,
may not prove safe or effective, the possibility that our existing
and new drug candidates may not receive approval from the FDA, and
other regulatory agencies in a timely manner or at all, the
possibility that our existing and new drug candidates, if approved,
may not be more effective, safer or more cost efficient than
competing drugs, the possibility that our efforts to acquire or in-
license and develop additional drug candidates may fail, our lack
of revenues, our limited marketing experience, our dependence on
third parties for clinical trials, manufacturing, distribution and
quality control and other risks that are described in further
detail in the Company's reports filed with the Securities and
Exchange Commission. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to
update the information contained in this press release except as
required by law. COMPANY CONTACTS MEDIA CONTACT Russell Skibsted
Susan Neath SVP & Chief Business Officer Porter Novelli Life
Sciences 619-849-6007 Paul Arndt Manager, Investor Relations
949-788-6700 DATASOURCE: Spectrum Pharmaceuticals, Inc. CONTACT:
Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,
Manager, Investor Relations, +1-949-788-6700, both of Spectrum
Pharmaceuticals; or Susan Neath of Porter Novelli Life Sciences,
+1-619-849-6007 Web site: http://www.spectrumpharm.com/
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