ADC Therapeutics Announces Exclusive License Agreement with Sobi to Develop and Commercialize ZYNLONTA (loncastuximab tesirine-lpyl) in Europe and Select International Territories

ADC Therapeutics SA announced it has entered into an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan. The Marketing Authorization Application (MAA) for ZYNLONTA was validated by the European Medicines Agency (EMA) at the end of October 2021, and orphan drug designation was granted for ZYNLONTA for the treatment of diffuse large B-cell lymphoma (DLBCL) in Europe. ADC Therapeutics and Sobi intend to make ZYNLONTA available following a regulatory decision that is expected by the first quarter of 2023.

Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $55 million, and is eligible to receive $50 million upon regulatory approval of ZYNLONTA in third-line DLBCL by the European Commission and up to approximately $330 million in additional regulatory and sales milestones. ADC Therapeutics will also receive a percentage of royalties ranging from the mid-teens to the mid-twenties based on net sales of ZYNLONTA in Sobi’s territories. Sobi will share a portion of select global ZYNLONTA clinical trial costs.

“We are thrilled to establish this important partnership with Sobi to continue expanding our global reach to bring ZYNLONTA to as many patients as possible worldwide,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Sobi has a strong global commercial infrastructure, proven capabilities in the areas of hematology and rare diseases, and importantly, shares our passion for improving the lives of patients.”

Guido Oelkers, Chief Executive Officer of Sobi, said, “ADC Therapeutics has an innovative and validated technology platform and is a leader in the evolving field of antibody-drug conjugates. We are delighted about this collaboration to bring loncastuximab tesirine to Europe and beyond to serve an unmet need in debilitating orphan diseases in haematology.”

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 DLBCL after two or more lines of systemic therapy. ADC Therapeutics has an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. 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 registrational pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China.