Incyte achieves regulatory milestone under ruxolitinib license agreement with Novartis

The recommendation by the CHMP of the EMA for approval of ruxolitinib to treat of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis has triggered the $40m payment.

Once Novartis achieves reimbursement and pricing approval in specific EU countries, a second $60m payment will be earned.

Ruxolitinib is known as Jakafi in the US and will be called Jakavi in Europe, the Incyte said.

In 2009, both the companies entered into a worldwide collaboration and license agreement under which Novartis gained exclusive rights for the development and commercialization of ruxolitinib in all hematology-oncology indications outside of the US.