IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News) today announced the formation of a Canadian affiliate, Spectrum Pharma Canada, Inc. headquartered in the Province of Québec, Canada.
“The establishment of Spectrum Pharma Canada is another important milestone as we build a global pharmaceutical organization,” said Rajesh C. Shrotriya, M.D., Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals. “The Canadian research infrastructure, highly qualified talent pool, and economic incentives provided by the individual provinces, especially the Province of Québec, were all factors in the establishment of this affiliate. Furthermore, we were impressed with the receptiveness of Investissement Québec, and are currently working with this state-owned corporation to help Spectrum Pharma Canada succeed in its mission.”
As announced in February 2008, the Therapeutic Product Directorate of Health Canada approved clinical trials to be conducted in Canada by issuing a No Objection Letter to Spectrum’s Clinical Trial Application for EOquin®. Patients are being enrolled at approximately 30 clinical centers in Canada, including the Province of Québec.
The EOquin® registration plan calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 evaluable patients with Ta G1 or G2 low risk non-muscle invasive bladder cancer (NMIBC).
Clinical studies with our second leading drug, Ozarelix, are likely to be initiated later this year, and to be followed by other drug development activities.
About EOquin®
EOquin® (apaziquone for intravesical instillation) is an anti-cancer agent that becomes activated by certain enzymes often present in higher amounts in cancer cells than in normal cells. It is currently being developed for the treatment of NMIBC, which is a cancer that is only in the innermost layers of the bladder and has not spread to the deeper, muscle layer of the bladder. EOquin® is formulated for administration directly into the urinary bladder.
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 with other intravesical agents. The data from this study were presented to the FDA in early 2006.
About Bladder Cancer
The American Cancer Society estimates that the 2008 incidence and prevalence of bladder cancer in the United States will be approximately 68,810 and over 500,000, respectively. Based on Globocan data, we estimate that the 2008 incidence and prevalence of bladder cancer in Europe is approximately 149,000 and 944,000, respectively. According to Botteman et al., (Pharmacoeconomics, 2003), bladder cancer is the most expensive cancer to treat on a lifetime basis.
The initial treatment of this cancer is complete surgical removal of the tumor. However, bladder cancer is a highly recurrent disease with approximately 75% of patients recurring within 5 years, and a majority of patients recurring within 2 years. This high recurrence rate is attributed to: 1) the highly implantable nature of cancer cells that are dispersed during surgery, 2) incomplete tumor resection, and 3) tumors present in multiple locations in the bladder which may be missed or too small to visualize at the time of resection. Despite evidence in the published literature and guidance from the American and European Urology Associations, instillation of a chemotherapeutic agent immediately following surgery is not a standard clinical practice. Currently, there are no approved drugs for this indication which may, in part, explain the difference between the literature and urology guidelines and actual clinical management of this disease. For more than 30 years no new drugs have been introduced in the market for the treatment of NMIBC.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus, and; leveraging the expertise of partners around the world to assist us in the execution of our strategy. 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 clinical studies with our second leading drug, Ozarelix, are likely to be initiated later this year to be followed with other drug development activities and any statements that relate to the intent, belief, plans or expectations of Spectrum Pharmaceuticals, Spectrum Pharma Canada, 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, our lack of a majority control over Spectrum Pharma Canada Inc., 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.® is a registered trademark of Spectrum Pharmaceuticals, Inc., and EOquin™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc. Russell Skibsted, 949-788-6700, x234 SVP & Chief Business Officer or Paul Arndt, 949-788-6700, x216 Manager, Investor Relations
Source: Spectrum Pharmaceuticals, Inc.