NEW YORK – Byondis and Medac on Tuesday announced a licensing deal to commercialize Byondis' anti-HER2 antibody-drug conjugate trastuzumab duocarmazine, also known as SYD985, if it is approved by regulators in Europe.
Under the terms of the agreement, Wedel, Germany-based Medac made an undisclosed upfront payment to Byondis for an exclusive license to commercialize the agent in the EU, UK, and other European countries. In the deal, Byondis will also receive future royalties on sales of the drug and is eligible for additional payments for achieving development and sales milestones.
SYD985 is designed to target a range of HER2-expressing cancers including metastatic breast and endometrial cancers. In the Phase III TULIP trial, advanced HER2-positive breast cancer patients garnered a significant progression-free survival benefit with the antibody-drug conjugate compared to those on physician's choice treatment. Researchers are still tracking SYD985's impact on overall survival in the ongoing TULIP trial, data from which will be included in regulatory filings for the HER2-targeted agent.
Nijmegen, Netherlands-based Byondis plans to submit a marketing authorization application to the European Medicines Agency soon. According to a statement from the firm, SYD985 is also pending approval with other regulators including the UK Medicines and Healthcare products Regulatory Agency.
Beyond breast cancer, Byondis has been evaluating the investigational agent in a Phase II trial for HER2-expressing advanced endometrial cancer.