Spectrum Pharmaceuticals Announces Submission Of Non-Clinical Section Of Rolling NDA For Satraplatin

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that its partner, GPC Biotech AG, has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). GPC Biotech submitted the chemistry, manufacturing and controls -- or CMC -- section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006. Under Spectrum's agreement with GPC Biotech for satraplatin, GPC Biotech is responsible for fully funding the development and regulatory expenses and will pay Spectrum royalties based on sales of this compound.

"The non-clinical information that was submitted by GPC Biotech to the FDA is the second of three parts necessary to complete the NDA submission of satraplatin and brings us one step closer to commercialization," stated Dr. Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum. "The data from the pivotal Phase 3 trial with satraplatin as a second-line treatment for HRPC, expected in the fall of this year, will complete the rolling NDA submission, and if satraplatin is approved, Spectrum could begin receiving royalties from the sales of satraplatin as early as second half 2007."

The FDA granted "fast track" designation for satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003. The FDA's fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.

About Satraplatin

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.

Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, the accrual to the SPARC trial was completed and the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA) was initiated. Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories outside the U.S.

Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.

About Spectrum

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 statements

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 and develop its portfolio of drug candidates, the Company's promising pipeline, satraplatin's ability to treat hormone-refractory prostate cancer, the potential of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers, the initiation of additional clinical trials for satraplatin, data from the trial are expected this fall, we anticipate the NDA submission will be completed by the end of 2006, commercialization of satraplatin, royalties from sales of satraplatin in 2007 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 price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, 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/