Date: 2012-07-18
Type of information: Licensing agreement
Compound: trastuzumab, being developed as a biosimilar to Herceptin®
Company: Synthon (The Netherlands) Amgen (USA) Watson Pharmaceuticals (USA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism:
Disease: breast cancer, gastric cancer
Details: Synthon has entered into a global license agreement with Amgen and Watson Pharmaceuticals, for Synthon’s trastuzumab, being developed as a biosimilar to Herceptin®, which is currently approved for treatment of breast cancer and gastric cancer. Synthon’s trastuzumab is one of the most advanced products in the company’s biopharmaceuticals pipeline. It is one of the first trastuzumab biosimilar products to have completed a Phase I trial in Europe.
Earlier this year, Synthon successfully completed a Phase I clinical trial in Europe showing bio-equivalence between its trastuzumab biosimilar and Herceptin®. The company was preparing for a confirmatory Phase III trial for Europe with this compound.
Under the agreement, Watson has acquired the license to the biosimilar program and has contributed it to the Amgen/Watson biosimilars collaboration. Amgen and Watson will assume responsibility for all future development work worldwide, including Phase III clinical trials, as well as global manufacturing and commercialization. Synthon will provide transitional support as set forth in the agreement.
Additional details of the transaction were not disclosed.
In December 2011 Amgen and Watson announced that they will collaborate to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients.
Financial terms: The deal entitles Synthon to an initial payment and potentially a milestone fee and royalties on net sales. Synthon will also receive compensation for its transitional support activities under the agreement. Synthon has retained rights to move forward independently with a HER2-targeted antibody-drug conjugate (ADC) candidate using its proprietary Linker-Drug technology.
Latest news:
