IRVINE, Calif., Dec. 15 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that the Company's co-development partner, GPC Biotech AG , has begun the rolling submission of a New Drug Application (NDA) with 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). To begin the rolling NDA process, the chemistry, manufacturing and controls (CMC) section of the NDA has been filed with the FDA.
"I am very pleased to announce this latest milestone in the development of satraplatin as a potential new treatment option for patients suffering from hormone refractory prostate cancer," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "In December alone, we achieved our target enrollment in the Phase 3 registrational trial, announced the opening of accrual of a Phase 2 study evaluating satraplatin in combination with Taxol(R) (paclitaxel) and reported that the independent Data Monitoring Board reviewed the safety data from the Phase 3 trial and recommended that the trial continue as planned. The submission of the rolling NDA is major step forward towards the ultimate goal of making satraplatin available to patients as quickly as possible."
The rolling submission process enables companies that have been granted "fast track" designation by the FDA 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. Under U.S. regulations, within sixty days after the receipt of such a submission, the FDA will determine whether that application may be filed. The filing of an application means that the FDA has determined that the application is sufficiently complete to permit a substantive review.
The FDA's fast track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The FDA granted fast track designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003.
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. Worldwide sales of these drugs exceeded $2.2 billion in 2004. 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. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Target enrollment has been achieved in a Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for HRPC. GPC Biotech has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication.
Phase 2 trials have been completed in HRPC, ovarian cancer and small-cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and Phase 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Further information on satraplatin can be found at the Company's website at www.spectrumpharm.com or in the Anticancer Programs section of GPC Biotech's website at www.gpc-biotech.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at 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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, satraplatin as a potential new treatment option for patients suffering from hormone refractory prostate cancer, completion of the filing of the NDA application in the 2nd Half of 2006, the ultimate goal of making satraplatin available to patients as quickly as possible, the advantages of an oral platinum drug, including ease of administration and patient convenience, in a variety of applications, the initiation of several other Phase 1 and Phase 2 studies evaluating satraplatin in combination with other therapies and in various cancers 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 past results are not indicative of future results, 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.
Contact: Laurie Little Sr. Director, Investor Relations (949) 743-9216
Spectrum Pharmaceuticals, Inc.CONTACT: Laurie Little, Sr. Director, Investor Relations, of SpectrumPharmaceuticals, Inc., +1-949-743-9216
