FDA Accepts Satraplatin NDA And Grants Priority Review
Main Category: Prostate / Prostate Cancer News
Article Date: 17 Apr 2007 - 0:00 PDT

Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) today announced that the New
Drug Application (NDA) for satraplatin has been accepted for priority review
by the U.S. Food & Drug Administration (FDA). A Prescription Drug User Fee
Act (PDUFA) date of August 15, 2007 has been established by the FDA for a
decision regarding the approval of the satraplatin application. Satraplatin
is an investigational drug for the treatment of hormone refractory prostate
cancer (HRPC) for those patients who have failed prior chemotherapy.

"The acceptance by the FDA of the satraplatin NDA represents an important
milestone for Spectrum as it validates our risk-reduced business model,"
said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive
Officer of Spectrum Pharmaceuticals. "We identified satraplatin as a
promising treatment for hormone refractory prostate cancer patients and
moved the product through development without incurring major development
expenses or diluting our shareholders. The regulatory and sales-related
milestone payments as well as the royalties we expect to receive related to
satraplatin will serve as a non- dilutive source of funding for the
advancement of our pipeline of nine other drugs including EOquin(TM) for
non-invasive bladder cancer in Phase 3 clinical trials, ozarelix for benign
prostatic hypertrophy, expected to enter Phase 3 clinical trials by year end
and SPI-1620 a novel adjunct to chemotherapy, expected to enter clinical
testing this year."

The FDA's acceptance of the NDA triggers a $4 million milestone payment to
Spectrum. Spectrum is also entitled to receive milestone payments upon the
achievement of additional regulatory milestones in the U.S., Europe, Japan
and other countries. Further payments are due on achieving certain sales
targets. In addition to milestones, Spectrum is entitled to receive
royalties on worldwide sales of satraplatin. The company also has
co-promotion rights in the U.S., now that the partner has announced its
decision to market satraplatin in the U.S.

A PDUFA date is the date by which the FDA is expected to review and act on
an NDA submission. A PDUFA date typically occurs ten months following the
submission of an NDA. However, a PDUFA date for an NDA that is granted
priority review typically occurs six months following the submission of the
NDA. The FDA grants priority review status to products that, if approved,
would address an unmet medical need or are considered to be potentially
significant therapeutic advancements over existing approved therapies in the
treatment, diagnosis or prevention of a disease. On the August 15, 2007
PDUFA date set for satraplatin, the FDA is expected to notify the Company
whether satraplatin will be approved for marketing in the US, or not.

About Prostate Cancer

Prostate cancer is the most common cancer among men in the U.S. and Europe.
According to the American Cancer Society, approximately 219,000 men in the
U.S. are expected to be diagnosed and over 27,000 men are expected to die
from the disease in 2007. 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.

About Satraplatin

Satraplatin, a fourth-generation, oral 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 oral compound and is given as capsules that patients can take at home.

In addition to HRPC, 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.

In 2002, Spectrum licensed the global rights to GPC Biotech. GPC Biotech is
responsible for all costs associated with the development and regulatory
filings of satraplatin. GPC Biotech 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.

Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
Spectrum is required to pay to Johnson Matthey $500,000 in cash upon
acceptance of the NDA by the FDA.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is opportunistically acquiring and advancing 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 undervalued drugs with demonstrated safety and
efficacy, and adding value through further clinical development and
selection of the most viable and low-risk 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 satraplatin-related milestones and royalties will
serve as a non-dilutive source of funding for the advancement of our
pipeline, that ozarelix is expected to enter phase 3 clinical trials by year
end for benign prostatic hypertrophy, that SPI-1620 is expected to enter
clinical testing this year, that on the August 15, 2007 PDUFA date set for
satraplatin, the FDA is expected to notify the Company whether satraplatin
will be approved for marketing in the US, or not, that 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 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.

Spectrum Pharmaceuticals, Inc.
http://www.spectrumpharm.com