Oncoscience has withdrawn its MAA for cancer drug candidate nimotuzumab because it would not be able to meet requirements for approval from the EMEA’s advisory committee in time.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. [Care to guess the results of that trial?]
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