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Therapure To Fill/Finish for YM MAb

Therapure Biopharma will provide fill and finish services for YM BioSciences' EGFR binder

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Therapure Biopharma will provide fill and finish services for YM BioSciences‘ nimotuzumab, a humanized monoclonal antibody currently being tried against a variety of cancers. Nimotuzumab is licensed to YM’s majority-owned Canadian subsidiary, CIMYM BioSciences Inc., by the Centre of Molecular Immunology (CIM).

Therapure will formulate and fill nimotuzumab into sterile vials in its aseptic GMP-certified and Health Canada-licensed fill suite in Mississauga, Canada. The final product will be utilized by YM BioSciences and its licensees, Daiichi Sankyo in Japan, Kuhnil in South Korea, and Oncoscience AG in Europe for all activities and by Innogene Kalbiotech, YM’s licensee in Southeast Asia, for global clinical trials.

Of the 32 trials currently underway, three Phase III trials and eight Phase II trials are being conducted by YM and its four licensees. Nimotuzumab has been approved for marketing in 23 countries including Argentina, Brazil, China, India, Indonesia and, most recently, Mexico. In 2009, worldwide revenues for EGFR-targeting MAbs like nimotuzumab are expected to reach $2 billion.

“We have been very pleased with the performance of nimotuzumab during our ongoing clinical development program advancing it toward the market,” said David Allan, chairman and chief executive officer of YM BioSciences. “Combining the supply of the active drug product from the Center Molecular Immunology with the fill/finish capabilities of Therapure’s manufacturing suite provides CIM and YM BioSciences with a cost-effective and complete Canadian solution that integrates the numerous skills required in the production of biologics and provides a North American GMP standard to the nimotuzumab manufacturing process. Our product is well suited to Therapure’s flexible and modern Health Canada-licensed facility.”

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