Right as it gets a date with FDA, Forma offloads IDH1 inhibitor to Rigel
An IDH1 inhibitor on the cusp of an FDA decision is changing hands.
Watertown, MA-based Forma Therapeutics has long made it clear that olutasidenib, its oral inhibitor of mutant isocitrate dehydrogenase 1, is a non-core program. So perhaps it’s little surprise that as the FDA accepts its NDA, Forma’s licensing the drug to Rigel Pharmaceuticals in a $235 million deal.
Rigel is only paying $2 million of that upfront, but Forma could collect another $17.5 million soon if it meets certain regulatory, approval and first commercial sales milestones. The rest is tied to future development and commercial work.
The deadline for FDA action is now set for Feb. 15, 2023.
Similar to Agios’ Tibsovo — which is now owned by Servier — olutasidenib is designed to treat a subset of relapsed or refractory acute myeloid leukemia: cases where patients have a confirmed IDH1 mutation. Registrational Phase II data suggested that on the primary endpoint of complete remission plus a complete remission with partial hematological recovery, the drug spurred a CR+CRh rate of 33%, with early analysis pointing to a median duration of 13.8 months.
“Given Rigel’s focus on hematologic diseases and cancers and the strength of their commercial infrastructure, we believe they are well-positioned to execute on our shared objective of delivering olutasidenib to patients in need,” Forma CEO Frank Lee said in a statement.
Forma’s main focus remains etavopivat, the oral PKR activator being positioned for sickle cell disease and a range of hematological disorders. Other hematology and oncology programs are relatively early-stage.
For Rigel, the deal adds what appears to be a sure shot on goal as a surprise Phase III flop clouds the expansion plans for its bleeding disorder drug Tavalisse (fostamatinib).