Biocon Biopharmaceuticals, a joint venture between Biocon and Cimab SA, has rights to the drug from Cimab for the Indian subcontinent. In other markets, including Europe, North America, Japan and the Pacific Rim countries excluding China, nimotuzumab is licensed to YM Biosciences’ majority owned subsidiary Cimym BioSciences.
“While our license for nimotuzumab does not extend to India, this approval is an important validation of the safety and efficacy of the drug,” said David Allan, chairman and CEO of YM BioSciences. “In addition, a significant amount of additional clinical data in head & neck cancer will be now generated in India as nimotuzumab is commercialized.”
Nimotuzumab is currently in a phase III trial in Europe in combination with radiation for the treatment of pediatric pontine glioma. YM BioSciences and Cimym BioSciences 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.
Cimab and its parent, the Center of Molecular Immunology, are also conducting trials with nimotuzumab in glioma, breast, esophageal, uterine cervix, prostate and head and neck cancers.