YM BioSciences Inc, an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency (EMEA) for marketing authorization of nimotuzumab. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
The application for the marketing authorization for nimotuzumab was submitted to the EMEA on October 4th, 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 AG 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'.
"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 paediatric glioma. 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," said David Allan, chairman and CEO of YM BioSciences. "We are very pleased that Oncoscience AG 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."
YM's subsidiary CIMYM BioSciences Inc is the licensee for the highly differentiated EGFR-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 best-in-class in an established area of cancer therapy. It is currently undergoing a YM sponsored confirmatory trial in paediatric 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 AG.
YM BioSciences is a company that identifies, develops and commercializes differentiated products principally in the area of oncology for patients worldwide.