--Spectrum Pharmaceuticals, Inc. headquarted in California announced the formation of a Canadian affiliate, Spectrum Pharma Canada, Inc. based in the province of Quebec.
"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 Quebec, were all factors in the establishment of this affiliate. Furthermore, we were impressed with the receptiveness of Investissement Quebec, 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(R). Patients are being enrolled at approximately 30 clinical centers in Canada, including the Province of Quebec.
The EOquin(R) 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.