YM BioSciences reports anti-EGFr drug nimotuzumab approved in India for treatment of head and neck cancer

24-Jul-2006

YM BioSciences Inc. reported that India's Drug Controller General has granted marketing approval to nimotuzumab, an anti-EGFr monoclonal antibody, for the treatment of head & neck cancer. Biocon Biopharmaceuticals Ltd, a joint venture between Biocon and CIMAB SA (Havana, Cuba), has rights to the drug from CIMAB for the Indian subcontinent. Nimotuzumab is also licensed to YM's majority owned subsidiary CIMYM BioSciences Inc. by CIMAB for the major market countries including Europe, North America, Japan and the Pacific Rim countries excluding China.

"While our license for nimotuzumab does not extend to India, this approval is an important validation of the safety and efficacy of the drug. In addition, a significant amount of additional clinical data in head & neck cancer will be now generated in India as nimotuzumab is commercialized," said David Allan, Chairman and CEO of YM BioSciences. "YM has been advised that in the trials undertaken by Biocon Biopharmaceuticals Ltd to gain approval for nimotuzumab no cases were observed of the severe rash commonly produced by similar agents with the same target, consistent with previous study results. The absence of this debilitating side-effect should prove a key differentiator for nimotuzumab in the marketplace."

Nimotuzumab is currently in a Phase IIl trial in Europe in combination with radiation for the treatment of pediatric pontine glioma. YM BioSciences and CIMYM BioSciences Inc. are preparing to file for authorization to conduct a trial in North America in pediatric pontine glioma. In addition, YM is developing nimotuzumab for non-small cell lung cancer and pancreatic cancer and proposes to pursue the clinical development of the drug in adult glioma, esophageal cancer and colorectal cancer. YM's licensor, CIMAB SA and its parent, the Center of Molecular Immunology, are conducting trials with nimotuzumab in glioma, breast, esophageal, uterine cervix, prostate and head and neck cancers.

https://www.bionity.com/en/news/56563/ym-biosciences-reports-anti-egfr-drug-nimotuzumab-approved-in-india-for-treatment-of-head-and-neck-cancer.html