Date: 2015-01-23
Type of information: Milestone
Compound: INCB18424 [Jakafi®/Jakavi®], INCB28060
Company: Novartis (Switzerland) Incyte Pharmaceuticals (USA - DE)
Therapeutic area: Cancer - Oncology - Rare diseases - Hematological diseases
Type agreement: development licensing commercialisation
Action mechanism: INCB18424 is an oral JAK1/JAK2 inhibitor and INCB28060 is an oral cMET inhibitor.
Disease: myelofibrosis, multiple cancers
Details: * On November 25, 2009, Incyte Corporation announced that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers. Under the terms of the agreement, Incyte will retain exclusive rights for the development and potential commercialization of INCB18424 in the US. Novartis will have responsibility for the future development and commercialization of INCB18424 in all hematology–oncology indications outside of the US. Novartis will also be responsible for the future worldwide development of INCB28060.
Financial terms: Novartis will make an upfront payment of $150 million to Incyte plus an immediate $60 million milestone payment for the initiation of the European Phase III trial of INCB18424, COMFORT-II, that began in July of this year. Novartis will receive ex-US commercialization rights for Incyte’s lead JAK inhibitor and global commercialization rights for the cMET inhibitor. Each company will be responsible for costs in their respective territories for the JAK inhibitor, with costs of collaborative studies shared equally. Incyte may also be eligible over time for additional payments of up to approximately $1.1 billion if future contingent development and commercialization milestones are achieved. Incyte is also eligible to receive tiered, double-digit royalty payments on future ex-US INCB18424 sales. Novartis will be responsible for all costs and activities for the cMET inhibitor after the Phase I clinical trial. Incyte is eligible to receive royalties on future sales of INCB28060 and has retained an option to co-develop and co-promote INCB28060.
Latest news: * On January 23, 2015, Incyte announced that it has earned a $25 million milestone payment from Novartis . This payment was triggered by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopting a positive opinion for Jakavi® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Incyte expects to record this amount as contract revenue, and receive the $25 million payment, in the first quarter of 2015.
