YM Biosciences Inc., a company has engaged in the acquisition, development and commercialization of oncology and acute care products, has announced that its majority owned subsidiary, CIM YM Biosciences Inc., has licensed development and marketing rights in Japan for its anti-Egfr humanized antibody, nimotuzumab, to Daiichi Pharmaceutical Co., Ltd. (a wholly owned subsidiary of Daiichi Sankyo Company, Ltd., one of Japan's largest pharmaceutical companies).
Under the terms of agreement, CIM YM will receive an up-front payment of US$14.5 million and significant milestone payments at certain stages of development for each of a number of indications as well as payments based on supply of nimotuzumab and sales performance in the territory. Daiichi will develop nimotuzumab for the Japanese market in several cancer indications.
"This is an exceptional agreement, which provides nimotuzumab with the prospect of accessing the second largest pharmaceutical market in the world. The license will result in a substantial broadening of the development and commercialization efforts directed to our anti-cancer antibody," stated David Allan, Chairman and CEO of YM Biosciences.
In July 2006, nimotuzumab was approved in India for the treatment of head and neck cancer. Nimotuzumab is currently in a phase IIl trial in Europe in combination with radiation for the treatment of paediatric pontine glioma. A trial in North America in paediatric pontine glioma is also currently in design. Nimotuzumab is being variously developed in non-small cell lung cancer, paediatric glioma and pancreatic cancer in Canada and Europe and YM is preparing to pursue further clinical development of the drug in adult glioma and colorectal cancer as well as a number of other indications.
YM's licensor, Cimab SA, and its parent, the Centre for Molecular Immunology, are conducting trials with nimotuzumab in glioma, breast, esophageal, uterine cervix, prostate and head and neck cancers. In the paediatric and adult trials in Europe, the head and neck trial in India, and in trials in Canada and elsewhere, the debilitating side effects of severe rash, diarrhoea, conjunctivitis and hypomagnesaemia, evident in some or all of the other products in development targeting the tyrosine kinase pathway, were not observed.