ADC Therapeutics and Sobi Sign $435 Million Deal to Expand Blood Cancer Drug’s Market

Switzerland-based ADC Therapeutics announced on July 8 that it entered an exclusive licensing agreement with Swedish pharma giant Sobi for the development and commercialization of Zynlonta outside of the United States, Greater China, Taiwan, Singapore, and Japan. The deal could bring ADC up to $435 million, largely dependent on the European Medicines Agency’s (EMA) regulatory decision scheduled for early 2023. 

Expanding Zynlonta’s Success Outside the US

The FDA granted Zynlonta accelerated approval as third-line therapy in April last year to treat relapsed or refractory large B-cell lymphoma (DLBCL). The antibody-drug conjugate-based treatment launched the following month and brought ADC $33.9 million throughout the rest of 2021. 

With a proven potential for success in the US, ADC’s deal with Sobi could bring Zynlonta to global communities with a focus on the European market. The EMA validated Zynlonta’s Marketing Authorization Application in October last year and granted Zynlonta Orphan Drug Designation to treat DLBCL. 

Sobi will give ADC $55 million upfront in the deal and, contingent upon European regulatory approval, an additional $50 million. If ADC can meet the demands of additional regulatory and sales milestones, it is eligible for approximately $330 million. In addition to these favorable conditions, ADC will be eligible for royalties from the mid-teens to mid-twenties percent on Zynlonta sales. 

Apart from its deal with Sobi, ADC created a joint venture with Overland Pharmaceuticals, called Overland ADCT BioPharma, to develop and commercialize Zynlonta in Greater China, Taiwan, and Singapore. ADC is also working with Mitsubishi Tanabe Pharma Corporation to develop and commercialize Zynlonta in Japan. 

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Driving ADC Forward With Zynlonta

With so much potential in the antibody-drug conjugate arena, ADC hopes to leverage the drug in additional indications in the future. ADC says it is studying Zynlonta as a therapeutic option in combination with other B-cell malignancies and earlier lines of therapy as opposed to its current third-line indication. 

ADC designed Zynlonta as a CD19-directed antibody-drug conjugate. After binding to a CD19-expressing protein, Zynlonta releases pyrrolobenzodiazepine (PBD), an antibiotic with antitumor properties. The PBD binds to DNA while remaining less visible to DNA repair mechanisms, ultimately resulting in tumor cell death. 

Antibody-drug conjugate technology is growing in popularity as it proves its worth, and it is proving its worth for ADC with the success of Zynlonta and the deals it has precipitated so far. 

Chief Executive Officer of ADC, Ameet Malik, said, “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. 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.”

Malik took the helm of ADC just two months ago and immediately impacted the company and his reputation with the $435 million deal. The morale boost comes at a critical time for Malik after heading Rafael Holding while its lead drug candidate failed in Phase 3 trials. 

Even as third-line therapy, Zynlonta is proving a formidable competitor in the oncology arena, and come early 2023, the EMA’s regulatory decision will carry a great deal of weight in the future success of Zynlonta. For now, ADC will continue reaping the benefits of American commercialization while it looks forward to what may come ahead for Zynlonta. 

Author

Reed Slater