11 July 2022 | Monday | News
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Sobi® announced an exclusive license agreement with ADC Therapeutics SA to develop and commercialise loncastuximab tesirine for use in haematology and other indications of large unmet medical need in Europe and most international markets. Loncastuximab tesirine is an antibody-drug conjugate (ADC) against CD19, a protein expressed on the surface of B cells. It is currently approved in the US for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The medicine has orphan drug designation in the EU and is under regulatory review with a decision anticipated in the first quarter of 2023.
The license agreement for loncastuximab tesirine aims at augmenting Sobi's presence in orphan diseases within haematology, one of Sobi's two main disease areas. The medicine will expand Sobi's offering to patients with debilitating orphan diseases in haematology and is anticipated to be made commercially available alongside other Sobi haematology medicines, including Doptelet®.
Guido Oelkers, CEO of Sobi: "Based on our commitment to provide innovative medicines that transform the lives of people with rare and debilitating diseases as well as our stated capital-allocation priorities, we are pleased to announce the license agreement with ADC Therapeutics for loncastuximab tesirine in Europe and most international markets. We believe Sobi's heritage and strong presence in haematology coupled with new medicines like Doptelet will provide a competitive platform for bringing loncastuximab tesirine to more patients with orphan diseases."
Ameet Mallik, CEO of ADC Therapeutics: "We are thrilled to establish this important partnership with Sobi to continue expanding our global reach to bring loncastuximab tesirine to as many patients as possible worldwide. Sobi has a strong global commercial infrastructure, proven capabilities in the areas of haematology and rare diseases, and importantly, shares our passion for improving the lives of patients."
In the EU, loncastuximab tesirine has orphan drug designation for the treatment of DLBCL and is under regulatory review since October 2021 with a decision anticipated in the first quarter of 2023. In April 2021, the US Food and Drug Administration granted accelerated approval for ZYNLONTA, the US brand name for loncastuximab tesirine, as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.
Under the terms of the license agreement, Sobi has been granted rights to develop and commercialise loncastuximab tesirine for all hematologic and solid tumour indications outside of the United States, greater China, Singapore and Japan. Sobi will pay USD 55 M in an upfront payment, to be financed by Sobi's cash reserves, and USD 50 M at EU regulatory approval in 3rd-line DLBCL. In addition, Sobi will pay royalties from mid-teens to mid-twenties per cent of net sales and up to approximately USD 330 M in potential regulatory and sales milestones. As loncastuximab tesirine is in development for other indications, Sobi will contribute 25 per cent of the direct development costs up to a cap of USD 10 M per year. ADC Therapeutics is responsible for clinical development and product supply to Sobi.