Therapure Biopharma to Provide Fill and Finish Services for YM BioSciences' Nimotuzumab

Strategic Insights -

YM BioSciences, a Canadian biopharmaceutical company, has announced that it has signed an agreement with Therapure Biopharma to provide fill and finish services for its humanized monoclonal antibody, nimotuzumab. The agreement will enable YM BioSciences to leverage Therapure's aseptic GMP certified and Health Canada-licensed fill suite in Mississauga, Canada to produce nimotuzumab for global clinical trials and commercial use.

Key Takeaways:

  • YM BioSciences has licensed nimotuzumab to CIMYM BioSciences, its majority-owned Canadian subsidiary, from the Centre of Molecular Immunology.
  • Therapure Biopharma will formulate and fill nimotuzumab into sterile vials in their aseptic GMP certified and Health Canada licensed fill suite.
  • The facility is built to FDA, EMEA, MHRA, and Health Canada standards, ensuring compliance with global regulatory requirements.
  • Nimotuzumab is being evaluated in 32 clinical studies worldwide, with three Phase III trials and eight Phase II trials being conducted between YM BioSciences and its four licensees.
  • Nimotuzumab has been approved for marketing in 23 countries, including Argentina, Brazil, China, India, Indonesia, and Mexico.
  • The global market for EGFR-targeting monoclonal antibodies is expected to reach $2 billion in 2009.
  • The agreement has been concluded between Therapure Biopharma and YM BioSciences, with implementation to occur upon finalization of the contract with CIM.
  • YM BioSciences' CEO, David Allan, and Therapure Biopharma's CEO, Thomas Wellner, have expressed their satisfaction with the agreement and its potential to bring a cost-effective and complete biologics manufacturing solution to the Canadian market.

Statistics:

  • 32 clinical studies worldwide for nimotuzumab
  • 3 Phase III trials and 8 Phase II trials being conducted between YM BioSciences and its four licensees
  • $2 billion global market for EGFR-targeting monoclonal antibodies in 2009
  • 23 countries where nimotuzumab has been approved for marketing
  • 1 majority-owned Canadian subsidiary, CIMYM BioSciences, for YM BioSciences

Sources:

YM BioSciences Inc. via NewsRx.com

Pediatrics Week editors and staff reports