ADC Therapeutics inks multi-million licensing deal with Sobi

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11.07.2022
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Sobi entered into 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. It is already approved in the US and under regulatory review in Europe with a decision anticipated in 2023.

Loncastuximab tesirine is an antibody-drug conjugate (ADC) against CD19, a protein expressed on the surface of B cells. In the EU, loncastuximab tesirine has orphan drug designation for the treatment of diffuse large B-cell lymphoma 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.

DLBCL is an aggressive, malignant, orphan disease in haematology with an incidence in Europe of approximately 4 cases per 100,000 adults per year. As many as 40 per cent of all patients with DLBCL will need at least a 2nd-line treatment as their disease is relapsing or refractory. For those patients, effective treatment options are limited, representing a critical unmet need.

CHF 55 M upfront payment

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.

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