Press Release: Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin
Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin * Patient Enrollment to Commence in 2Q07 at More Than 50 United States Sites IRVINE, Calif., March 13, 2007 -- Spectrum Pharmaceuticals, Inc. today announced that an agreement with the U.S. Food and Drug Administration (FDA) has been reached under the Special Protocol Assessment (SPA) procedure for the Company's non-invasive bladder cancer drug candidate EOquin. The SPA process allows for an agreement between Spectrum Pharmaceuticals and the FDA on the design of a study, including clinical drug supply, pivotal trial design, clinical endpoints, conduct, data analysis, and other clinical trial issues, and is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a New Drug Application (NDA) by the Company for EOquin. "Bladder cancer is one of the most common cancers in the U.S. and there has not been a new treatment approved by the FDA in over 20 years. We believe the initiation of the Phase 3 trial of EOquin is an important step in bringing a more effective treatment for bladder cancer," stated Rajesh Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We have already selected approximately 50 investigators for the clinical trials in the U.S. and expect to conduct an investigator's meeting on March 30-31, 2007." The EOquin SPA calls for two double-blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562-patients with Ta G1 G2 non-invasive bladder cancer. The primary endpoint will be a statistically significant difference (p < 0.05) in the rate of tumor recurrence between the two treatment groups by year two. The Company currently anticipates enrollment of the first patients in the United States trial in the second quarter of 2007. Bladder cancer strikes approximately 62,000 new patients in the U.S. and approximately 180,000 patients in Europe each year. At any given time, it is estimated that there are more than 400,000 patients in the U.S. and more than one million patients in Europe. Bladder cancer is fifth most expensive cancer to treat. Additional information will be available regarding the design, enrollment criteria, and participating centers, at www.spectrumpharm.com, and www.clinicaltrials.gov (keyword: EOquin). About Special Protocol Assessment The PDUFA goals for Special Protocol Assessment and agreement provide that, upon request, FDA will evaluate within 45 days certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. The clinical protocols for Phase 3 trials can relate to efficacy claims that will be part of an original NDA. For more information on Special Protocol Assessment, go to http://www.fda.gov/cber/gdlns/protocol.htm#ii. About EOquin EOquin (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of non-invasive bladder cancer, which is a cancer that has invaded the inner most lining of the bladder. EOquin, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In a Phase 2 pilot study for which patient accrual was completed this year, EOquin instilled into the bladder following TUR-BT was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, would carry a low risk of harming the rest of the body. Spectrum Pharmaceuticals completed a multi-center, Phase 2 clinical trial in Europe. The results of the trial showed that EOquin was well tolerated and produced 67% CRs (complete responses) in patients, many of whom had been treated multiple times. The data from this study were presented to the FDA in early 2006. About Bladder Cancer The American Cancer Society estimates that there were more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. The estimated patient population with bladder cancer is over 400,000 in the United States. Non-invasive bladder cancer accounts for 75% to 80% of all cases of bladder cancer at first diagnosis. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, patients are usually prescribed additional therapy to prevent or delay such recurrences. This additional therapy generally consists of immunotherapy or chemotherapy drugs instilled directly into the bladder. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer. About Spectrum Pharmaceuticals Spectrum Pharmaceuticals acquires and develops 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 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 and develop its portfolio of drug candidates, the Company's promising pipeline, our team's ability to identify promising drugs and opportunistically move these drugs through development and toward commercialization, that the initiation of the Phase 3 trial of EOquin is an important step in bringing a more effective treatment for bladder cancer, that we will enroll the first patients in the United States trial in the second quarter of 2007, the safety and efficacy of EOquin 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.