Synthon today announced that it has entered into a global license agreement with Amgen Inc. and Watson Pharmaceuticals, Inc. for Synthon’s trastuzumab, being developed as a biosimilar to Herceptin, which is currently approved for treatment of breast cancer and gastric cancer.
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. 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.
Rudy Mareel, CEO of Synthon, commented: ”We are very pleased to partner with Amgen and Watson for our trastuzumab biosimilar, positioning it for success in the next phases of its development and commercialization. The agreement is testimony to the quality of Synthon’s science and our innovative strength, which we will continue to foster and invest in.”
‘’We are impressed with Synthon’s trastuzumab program and are anxious to advance it, consistent with our goal of reliably serving patients worldwide with high quality biosimilar products”, said Scott Foraker, VP/GM Biosimilars at Amgen.
“This transaction with Synthon reflects the determination of all three parties to maximize the value of biosimilar trastuzumab through accelerated product development, and demonstrates the flexibility of the collaboration between Amgen and Watson by combining our expertise to identify and execute on opportunities to participate at market formation,” said Fred Wilkinson, President, Watson Global Brands and Biosimilars.
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.
Source: Synthon press release