The application for the marketing authorization for nimotuzumab was submitted to the European Medicines Agency on October 4, 2007. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP). In its official letter Oncoscience states that the withdrawal of the application was made ‘because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule’.
YM’s subsidiary Cimym BioSciences is the licensee for the highly differentiated epidermal growth factor receptor-targeting drug, nimotuzumab, for most of the major market territories including Japan, Europe and North America.
Nimotuzumab is already approved for sale in a number of countries and the data continues to demonstrate the prospect for this molecule to be in an established area of cancer therapy. It is currently undergoing YM sponsored confirmatory trial in pediatric glioma in Canada and the US while being advanced in several Phase II and III trials by YM’s licensees and other companies advancing the drug internationally.
Cimym continues with its application to the London Court of International Arbitration for resolution of matters related to the license with Oncoscience.
David Allan, chairman and CEO of YM BioSciences, said: We are very pleased that Oncoscience withdrew its application in anticipation of a later resubmission as this application was based on a very small sample that was not prospectively studied. We note that this withdrawal is consistent with actions taken by numerous large and development stage pharmaceutical companies under similar circumstances and we believe it was the correct means for managing the quantity of information that is required in these submissions.