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August 3, 2022

Rigel and Forma enter licence deal for acute myeloid leukaemia therapy

In a Phase II registrational study in mIDH1 R/R AML patients, olutasidenib showed a strong duration of response.

Rigel Pharmaceuticals has signed a licence agreement with Forma Therapeutics for developing, producing and marketing olutasidenib to potentially treat relapsed/refractory acute myeloid leukaemia (R/R AML) and other types of cancer. 

Olutasidenib, an investigational agent, is an oral, small molecule inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1) that attaches to and hinders mutated IDH1 enzymes.

According to the latest exclusive, global agreement, Forma is entitled to get $2m in upfront payments.

The company is also eligible for another $17.5m on meeting specific near-term regulatory, approval and initial commercial sale milestones. 

Furthermore, on meeting certain development and commercial milestones, Forma will receive payments totalling up to another $215.5m and tiered royalty payments.

Rigel will oversee olutasidenib’s potential launch and marketing in the US and plans to enter partnerships to advance its development and commercialisation outside the country.

A New Drug Application (NDA) for olutasidenib filed by Forma was accepted by the US Food and Drug Administration (FDA), and a regulatory decision is anticipated on 15 February next year.

On obtaining approval, olutasidenib could become the second commercial product of Rigel in haematology-oncology.

In a Phase II registrational study in mIDH1 R/R AML patients, olutasidenib showed a strong duration of response and composite complete remission rate.

Rigel president and CEO Raul Rodriguez said: “Olutasidenib is a potential market-leading treatment that we believe, based on the registrational Phase II data, can improve outcomes in patients with mIDH1+ relapsed or refractory acute myeloid leukaemia, and is a strategic fit for our business.

“This transaction expands our haematology-oncology portfolio and enables us to leverage our strong commercial capabilities to provide a potential new therapy for these patients who remain underserved despite currently available therapies.”

In February last year, Rigel and Eli Lilly and Company signed a global exclusive licence agreement and strategic collaboration for jointly developing and commercialising the former’s R552 for all indications, including autoimmune and inflammatory ailments.

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