Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company, has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany.
 
Byondis and medac are partnering to commercialize Byondis’ lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.
 
Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications. Byondis will receive an undisclosed upfront payment and sales royalties, and will also be eligible for payments upon achievement of certain development and sales milestones.
 
“This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options,” said Byondis founder and chairman Jacques Lemmens, Ph.D.
 
“Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it,” commented medac managing director, CEO Jörg Hans.
 
Byondis CEO Marco Timmers, Ph.D. added: “We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients.”
 
SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors. Data from the SYD985 pivotal Phase III TULIP study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician’s choice (PC) treatment. TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA. The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).