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Incyte Reports 2012 Fourth-Quarter And Full-Year Financial Results; Provides 2013 Financial Guidance; Updates Shareholders On Key Clinical Programs

Data presented at ASH included results from a three-year follow-up of patients with polycythemia vera (PV) in a Phase II study, showing that ruxolitinib treatment resulted in durable overall response rates by modified European Leukemia Net criteria and improvements in PV-related symptoms.

Two Phase III clinical trials (RESPONSE and RELIEF), in partnership with Novartis, are underway to evaluate ruxolitinib in patients with PV, and results are expected to be part of a supplemental new drug application submission in 2014. The FDA has granted fast track designation for PV, specifically for the treatment of patients with PV who are resistant to or intolerant of hydroxyurea. Recruitment of the RESPONSE study has been completed.

A randomized Phase II trial of ruxolitinib in combination with capecitabine is fully enrolled with approximately 135 patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial), with final results expected in the second half of 2013.

Multiple investigator-sponsored trials evaluating ruxolitinib are ongoing, including two Phase I/II trials in adults with advanced hematologic malignancies (acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome and chronic myelogenous leukemia) and relapsed or refractory acute leukemia; a Phase I/II trial in children with hematologic malignancies and solid tumors; and a Phase II trial in patients with lymphoma. In addition, two of several planned investigator-sponsored Phase II trials to evaluate ruxolitinib in treating patients with breast cancer have been initiated.

Baricitinib - a JAK1 and JAK2 Inhibitor

Data from the six-month Phase IIb trial of baricitinib in patients with rheumatoid arthritis, conducted by our collaboration partner Eli Lilly, were presented at the American College of Rheumatology Annual Scientific Meeting in November 2012. Positive results from the 12- to 24-week portion of the study, which did not include continuation of the placebo control past week 12, showed that patients who received 2 mg, 4 mg or 8 mg baricitinib once-daily doses maintained or improved ACR20, ACR50 and ACR70 responses.

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