Incyte acquires rights from Lilly to develop Ruxolitinib to treat graft-versus-host disease

Additionally, Incyte has amended its Collaboration and License Agreement with Novartis, granting Novartis exclusive research, development and commercialization rights for ruxolitinib in GVHD outside the U.S.

"We are committed to the research and development of innovative medicines that will benefit patients with serious diseases, like GVHD, where there are no approved treatments," said Hervé Hoppenot, President and CEO, Incyte.

"We are very pleased to be able to expand our development opportunities for ruxolitinib and plan to initiate a registration study in GVHD later this year as we seek to accelerate the availability of a treatment option for patients with this life-threatening disorder."

Incyte and Lilly have agreed to amend their License, Development and Commercialization Agreement to enable Incyte to independently develop and commercialize ruxolitinib for GVHD. Incyte will make an upfront payment of $35 million to Lilly. The terms of the agreement also include additional potential payments by Incyte to Lilly upon the achievement of certain regulatory milestones.

Additionally, Incyte and Novartis have agreed to amend their Collaboration and License Agreement, granting Novartis the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S. Novartis will make payments to Incyte upon the achievement of certain development and regulatory milestones.

If approved, Incyte expects to commercialize ruxolitinib for GVHD in the U.S. and under the terms of the existing Collaboration and License Agreement would be eligible to receive potential milestone payments and royalties on sales of ruxolitinib in GVHD by Novartis outside the U.S.

About GVHD

Graft-versus-host disease (GVHD) is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue). In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. There are two forms of GVHD; acute and chronic. GVHD is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with GVHD.

About Ruxolitinib (Jakafi)

Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

Ruxolitinib is not approved anywhere in the world as treatment for graft-versus-host disease.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States.