YM BioSciences and Therapure Biopharma Announce Contract
News Dec 24, 2009
David Allan, Chairman and CEO of YM BioSciences Inc. and Thomas Wellner, President and CEO of Therapure Biopharma Inc., 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."
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.
Quotient Sciences Acquires Pharmaterials, a UK-based Contract Development and Manufacturing OrganizationNews
Quotient Sciences, the drug development services organization, announces it has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K..READ MORE
Researchers Discover Mutation That Appears to Protect Against Multiple Aspects of Biological AgingNews
The first genetic mutation that appears to protect against multiple aspects of biological aging in humans has been discovered in an extended family of Old Order Amish living in the vicinity of Berne, Indiana, report Northwestern Medicine scientists.READ MORE
Researchers Find a Way to Separate Side Effects of Opioid Drugs Reducing RiskNews
Scientists have discovered a way to separate these two effects -- pain relief and breathing, opening a window of opportunity to make effective pain medications without the risk of respiratory failure.READ MORE