(RTTNews) – Swedish Orphan Biovitrum AB or Sobi (SWTUY.PK), a specialty biopharmaceutical company, announced on Friday an exclusive license agreement with ADC Therapeutics SA for loncastuximab tesirine.

Under the terms of the agreement, Sobi has been granted the rights to develop and commercialize loncastuximab tesirine for all hematology and solid tumor indications in Europe and most international markets outside of the United States, Greater China, Singapore and Japan.

Sobi will pay $55 million in upfront payment, which will be funded from Sobi’s cash reserves, and $50 million upon EU regulatory approval in the 3rd line DLBCL.

The company will also pay royalties between the mid-teens and mid-twenties percent of net sales and up to approximately $330 million in potential regulatory and commercial milestones.

As loncastuximab tesirine is under development for other indications, Sobi will contribute 25% of direct development costs up to a cap of $10 million per year. ADC Therapeutics is responsible for clinical development and product delivery to Sobi.

Loncastuximab tesirine is an antibody-drug conjugate or ADC directed against CD19, a protein expressed on the surface of B cells.

In April 2021, the U.S. Food and Drug Administration granted accelerated approval for ZYNLONTA, the U.S. brand name of loncastuximab tesirine, as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or several lines of systemic treatment.

In the EU, the drug has orphan drug designation to treat DLBCL and has been under regulatory review since October 2021 with a decision expected in Q1 2023.

The agreement should increase Sobi’s presence in orphan diseases within hematology. The drug would be marketed alongside other Sobi hematology drugs, including Doptelet.

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