Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI) today announced that it has received notice from the European Medicines Agency ("EMEA) that it agrees with the overall clinical development plan, design and endpoints of the pivotal North American Phase 3 trials for EOquin, the Company's lead drug candidate for non-invasive bladder cancer. Two Phase 3 protocols are open and currently recruiting patients in North America. The trial design was reviewed under a Special Protocol Assessment procedure with the FDA. The EMEA agrees that the current placebo-controlled studies as designed should be sufficient for a regulatory decision regarding European registration. Additionally, the EMEA indicated that, pending a review of the study outcomes, no additional safety data would be required for registration.
"We are pleased to announce that we have received a favorable response to our request for scientific advice from the EMEA regarding the registration of EOquin in Europe, said Rajesh C. Shrotriya, MD, President and Chief Executive Officer of Spectrum Pharmaceuticals. "This is a significant advancement for the EOquin program, as the advice indicates that we will not be required to repeat the current North American studies in Europe for registrational purposes. Having a defined registration path in Europe, where the incidence and prevalence of bladder cancer is about double that in the US, makes EOquin an even more attractive licensing candidate for potential global partners that seek to serve this large and underserved patient population.
European Association of Urology guidelines currently recommend an immediate single, post-operative instillation of a chemotherapeutic agent following trans-urethral resection of a bladder tumor in all patients with low risk bladder cancer, as it has been shown in clinical studies to decrease the risk of recurrence. The recent American Urology Association guidelines on the treatment of low risk non-invasive bladder cancer recommend that a single immediate post-operative installation of a chemotherapeutic agent following trans-urethral resection be considered an option for these patients. Thus, if the US FDA and the EMEA ultimately approve EOquin for this indication, EOquin would fill an unmet medical need and be the only drug approved by these agencies for immediate instillation in low-risk bladder cancer.
The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase 3 clinical trials in patients with low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint is the difference in the rate of tumor recurrence between the two treatment groups by year two.
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 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 which was completed earlier this year, EOquin instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.
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 a 67% CR (complete response) 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 67,160 new cases of bladder cancer will be found in the United States. According to Globocan Data estimates, approximately 147,000 new patients will be diagnosed with bladder cancer in Europe during 2007. The American Cancer Society estimates that approximately 13,750 people will die of this disease in the U.S. in 2007. Globocan Data estimates more than 53,000 will die in Europe in 2007. According to these sources, at any given time, it is estimated that there are more than 500,000 patients in the U.S. and more than 935 thousand patients in Europe living with bladder cancer. Non-invasive bladder cancer accounts for 75 to 80 percent 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 on a lifetime basis. 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.
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. 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, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, the safety and efficacy of EOquin, that EOquin is expected to carry a low risk of systemic toxicity, that EOquin is an attractive licensing candidate for potential global partners, that EOquin will fill an unmet medical need 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, including EOquin, may not receive approval from the FDA or the EMEA, 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.