Therapure Biopharma to fill/finish nimotuzumab at its Canadian GMP certified fill suite

Dec 17 2009

- Therapure Biopharma to perform fill/finish of nimotuzumab -

David Allan, Chairman and CEO of YM BioSciences Inc. and Thomas Wellner, President and CEO of Therapure Biopharma Inc. today announced the signing of an agreement under which Therapure Biopharma will provide fill and finish services for nimotuzumab, the humanized monoclonal antibody licensed to YM's majority-owned Canadian subsidiary, CIMYM BioSciences Inc., by the Centre of Molecular Immunology (CIM). Under the terms of the agreement, Therapure will formulate and fill nimotuzumab into sterile vials in their aseptic GMP certified and Health Canada licensed fill suite in Mississauga, Canada. The facility is built to FDA, EMEA, MHRA and Health Canada standards. 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.

Nimotuzumab is a humanized monoclonal antibody that targets and binds to the epidermal growth factor receptor (EGFR), the well-validated oncology target. Nimotuzumab is currently being evaluated in 32 clinical studies worldwide in numerous indications, including multiple stages of non-small-cell lung cancer, pediatric and adult glioma, esophageal cancer, pancreatic cancer, gastric cancer and head & neck cancer. Three Phase III trials and eight Phase II trials of those 32 are being conducted between 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 monoclonal antibodies are expected to approximate $2 billion.

"We have been very pleased with the performance of nimotuzumab during our on-going clinical development program advancing it toward the market," said David Allan. "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."

"Therapure Biopharma is proud to be able to work with YM BioSciences and to apply our expertise to support the clinical evaluation of this differentiated drug, and we look forward to continuing the process through supply of the commercial product when marketing authorizations are granted in the major markets," said Thomas Wellner. "Therapure Biopharma has much experience filling and finishing a variety of biopharmaceutical products in different formats. Working closely with YM BioSciences, another successful Canadian-based biotech company, has allowed us to meet their quality requirements for a successful globalization of this exciting cancer treatment."

The agreement has been concluded between Therapure Biopharma and YM BioSciences and the implementation of the agreement will occur upon the finalization of the contract agreed with CIM.