LAUSANNE, Switzerland– ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today announced it has entered an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA® (loncastuximab tesirine-lpyl) for all hematologic and solid tumor indications in Japan.
Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $30 million and up to an additional $205 million in milestones if certain development and commercial events are achieved. ADC Therapeutics will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in Japan. MTPC will conduct clinical studies of ZYNLONTA in Japan and will have the right to participate in any global clinical studies of the product by bearing a portion of the costs of the study.
“This license agreement with MTPC, a leader in the Japanese pharmaceutical industry, expands our global footprint in an important geography, and furthers our goal to make ZYNLONTA available globally to patients,” said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. “We are excited to bring together our expertise in ADCs with MTPC’s extensive experience in Japan where there is significant unmet need for a safe and effective therapy for patients with relapsed or refractory DLBCL.”
“MTPC is delighted to collaborate with ADC Therapeutics, a leader in the field of antibody drug conjugates, to develop and commercialize ZYNLONTA in Japan,” said Hiroaki Ueno, PhD, Chief Executive Officer of Mitsubishi Tanabe Pharma Corporation. “We will try to improve the quality of life of patients suffering from cancer with the use of ADC Therapeutics’ novel anti-CD19 ADC, ZYNLONTA.”
In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. A Marketing Authorization Application (MAA) for ZYNLONTA has been validated by the European Medicines Agency (EMA) and is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). ZYNLONTA has also received Orphan Drug designation in Europe for DLBCL. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China, which is intended to support the anticipated registration of ZYNLONTA in China.
