Move follows filing of arbitration by YM BioSciences stating inappropriate actions taken for approval.
Oncoscience has withdrawn its MAA for cancer drug candidate nimotuzumab because it would not be able to meet requirements for approval from the EMEA’s advisory committee in time. The Committee for Medicinal Products for Human Use (CHMP) expressed concerns regarding the quality and efficacy of nimotuzumab.
Oncoscience holds the European license for this compound from YM BioSciences’ subsidiary, CIMYM BioSciences. The MAA, submitted to the EMEA on October 4, 2007, was based on a small Phase II trial. On November 17, CIMYM BioSciences notified Oncoscience that it planned to submit issues for arbitration to the London Court of International Arbitration (LCIA) as the firm felt that Oncoscience was not taking the correct steps to gain approval in the EU.
“The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma,” states David Allan, Chairman and CEO of YM BioSciences.
Oncoscience has completed a Phase III trial, according to James Smith, YM BioSciences’ investor relations representative. He noted that more robust information is thus available but couldn’t comment on Oncosciences plans going forward.
No one from Oncoscience was immediately available to comment on why an MAA was filed at this early stage or what the future plan for European approval would be.
Smith went on to note that the strategy for approval followed by Oncoscience was not acceptable by the other companies involved in the development and commercialization of nimotuzumab. The application with LCIA would also seek to determine if the issues raised are justification to terminate the license agreeement with Oncoscience.
CIMYM BioSciences is the licensee for nimotuzumab, an EGFR-targeting drug, for most major markets including Japan, Europe, and North America. Nimotuzumab is currently undergoing a trial in pediatric glioma in Canada and the U.S. while being advanced in several Phase II and III trials by YM’s licensees and other companies internationally.
“This analysis in no manner reflects on the overall efficacy of nimotuzumab, which already has been approved for marketing in twelve countries with efficacy demonstrated in numerous indications,” Allan continues.