Rigel makes Forma wait for olutasidenib payday

Two competitive datasets on olutasidenib in IDH1-mutated AML at last year’s Ash meeting boded well for Forma’s ambitions to find a partner, so the terms of yesterday's licensing deal come as a surprise. Rigel is buying worldwide olutasidenib rights for just $2m, plus $17.5m in near-term and $215.5m in longer-term milestones; royalties are at least healthy, stretching to the mid-30s. One explanation for the small up-front is that IDH mutations are rare; the market is tiny and has several competitors. Servier’s Tibsovo is dominant and Rigel will have to work hard to grab share; the private French group does not disclose sales, although Agios generated $120m in 2020, before it sold out to Servier. B Riley analysts estimate peak sales of $100m for olutasidenib in front-line and refractory AML. Pipeline IDH projects are focused on glioma, where Servier is also in the lead with a second Agios asset. Lilly is probably the one to watch, however, with a Loxo-originated project. Data due next year from two large phase 1 trials could show whether Rigel was right to backend load the deal terms.

Hitting IDH mutations: the competitor landscape   
Project Target Company Status
Idhifa (enasidenib)  IDH2 Bristol Myers Squibb (ex Celgene/Agios) US approved for r/r mIDH2 AML
Tibsovo (ivosidenib)  IDH1 Servier (ex Agios) US approved for 1L (mono and + Vidaza) & r/r mIDH1 AML, & 2L mIDH1 cholangio; numerous company and academia-sponsored studies ongoing in solid tumours + Opdivo, chondrosarcoma, clonal cytopenia
IDH1 Rigel (ex Forma) Pdufa date 15 Feb 2023 for r/r mIDH1 AML or MDS
Vorasidenib IDH1 & 2 Servier (ex Agios) Ph3 in mIDH1/2 glioma, results expected 2023/24ph1 in astrocytoma + Keytruda due to start
IDH1 Anheart (ex Daiichi Sankyo) Ph2 in 1L mIDH1 glioma
LY3410738 IDH1 Lilly (ex Loxo) 2x ph1 in mIDH1/2 haem & solid tumours ongoing; data due next year
HMPL-306 IDH1 & 2 Hutchmed 3x ph1 in mIDH1/2 haem & solid tumours (US/Europe + China focus); dose expansions ongoing
BAY1436032 IDH1 Bayer Ph1 in mIDH1 solid tumours (likely abandoned, no new trials started since 2017)
IDH305 IDH1 Novartis Abandoned
Source: Evaluate Pharma & company statements.

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