Days after US regulators removed a clinical hold on imetelstat, Geron Corp has sealed a licensing deal with Johnson & Johnson for the drug which could be worth $935 million.
J&J is paying $35 million upfront for imetelstat, a telomerase inhibitor, which is in early phase development for myelofibrosis. The healthcare giant noted that it may have activity in other haematologic myeloid malignancies such as myelodysplastic syndrome (MDS) and acute myelogenous leukaemia.
The deal represents a good start to November for Geron given that earlier this month, its stock shot up after the US Food and Drug Administration removed its full clinical hold on imetelstat. The agency stated that the firm’s development plan for the drug, which is “focused on high-risk myeloid malignancies…is acceptable”.
The FDA also acknowledged Geron’s previously-disclosed decision not to develop imetelstat for essential thrombocythemia or polycythemia vera. The biotech is therefore allowed to carry on in the clinic and bagging a partner like J&J is a boost.
Geron now expects an initial Phase II study in MF to be initiated in mid-2015, followed later by a Phase II MDS study. On top of the upfront fee, the company is eligible to receive $900 million for the achievement of the usual milestones, as well as royalties, although development costs for the two aforementioned studies will be shared on a 50/50 basis.
While it may not be a massive deal, Geron investors seemed pleased as the stock was up 30.3% in after-hours trading.