Incyte Earns $19M Milestone from Lilly on Start of Phase IIb Trial with RA Candidate

Firm’s JAK inhibitor pipeline includes Phase III-stage candidate against myelofibrosis.

Incyte has received a $19 million milestone payment from Eli Lilly as a result of the latter starting a Phase IIb trial with the JAK1/JAK2 inhibitor INCB28050 for the treatment of rheumatoid arthritis (RA). Lilly has exclusive worldwide rights to the Incyte drug candidate, which is now being renamed LY3009104. The dose-ranging Phase II global trial is expected to include 270 patients with active rheumatoid arthritis.

Incyte has two JAK inhibitor candidates in development. Lead product, INCB18424, is a JAK1/2 inhibitor currently in Phase III development as an oral therapy for myelofibrosis. The drug is separately in Phase II development as an oral treatment for polycythemia vera and for essential thrombocythemia. It is in addition undergoing Phase II evaluation as a topical therapy for psoriasis. In September Incyte announced that it had reached an agreement with FDA regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its INCB18424 in patients with polycythemia vera.

Incyte and Novartis signed a collaboration and license agreement for INCB18424 and Incyte’s Phase I-stage cMET inhibitor candidate INCB28060 in November 2009. Under terms of the deal, Incyte retains exclusive rights to develop and commercialize INCB18424 in the U.S. Novartis has exclusive rights to develop and commercialize INCB18424 for all hematology-oncology applications in the rest of the world. The firm also has worldwide rights to the cMET inhibitor INCB28060.

Financial terms of the agreement included a $150 million up-front payment from Novartis to Incyte, plus an immediate $60 million milestone payment relating to the prior initiation of a European Phase III trial of INCB18424. Incyte could receive about another $1.1 billion in development and commercialization milestones, plus tiered, double-digit royalties on sales by Novartis of INCB18424 in its licensed territories.

The family of Janus kinase (JAK) enzymes mediate the signalling of a number of key drivers of myeloproliferative neoplasms, other hematological malignancies, and inflammatory diseases, Incyte explains. There are four known JAK enzymes: JAK1, 2, 3, and tyrosine kinase 2 (TYK2). JAK1, JAK2, and TYK2 are expressed in multiple tissues, while JAK3 is restricted to cells involved in the formation and development of blood. Hyperactivation of JAKs has been associated with a number of disease states, including chronic myeloproliferative disorders, inflammatory diseases such as rheumatoid arthritis and psoriasis, and certain hematologic and solid cancers.