Recent Clinical Highlights

Jakafi ® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
  • The use of Jakafi to treat patients with intermediate or high-risk myelofibrosis (MF) is further supported by presentations to be made at the American Society of Hematology annual meeting in December, including updates from COMFORT-I and COMFORT-II.
    • Verstovsek, S, et al. Long-Term Outcome of Ruxolitinib Treatment in Patients with Myelofibrosis: Durable Reductions in Spleen Volume, Improvements in Quality of Life, and Overall Survival Advantage in Comfort-I. Dec. 10, 2012, at 6:30 p.m.
    • Cervantes, F, et al. Long-Term Safety, Efficacy, and Survival Findings From Comfort-II, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy (BAT) for the Treatment of Myelofibrosis (MF). Dec. 10, 2012, at 6:45 p.m.
    • Vannucchi, A, et al. Reductions in JAK2 V617F Allele Burden with Ruxolitinib Treatment in Comfort-II, A Phase 3 Study Comparing the Efficacy and Safety of Ruxolitinib with Best Available Therapy (BAT). Dec. 10, 2012, at 7 p.m.
  • Two Phase III clinical trials (RESPONSE and RELIEF), in partnership with Novartis, are underway to evaluate ruxolitinib in patients with polycythemia vera (PV) with results 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.
  • A randomized Phase II trial of ruxolitinib in combination with capecitabine is actively recruiting patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial). The RECAP trial is designed to enroll approximately 130 patients by late 2012, 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, the first of several planned investigator-sponsored Phase II trials to evaluate ruxolitinib in treating patients with breast cancer was recently initiated.

Baricitinib, formerly known as LY3009104 (INCB28050) - 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 and Company, will be presented at the American College of Rheumatology Annual Scientific Meeting in November 2012.
  • A Phase III trial of baricitinib in patients with rheumatoid arthritis, conducted by Lilly, began screening patients in October 2012.
  • A Phase IIb trial in patients with moderate to severe psoriasis, conducted by Lilly, is ongoing with primary endpoint results expected in 2013.
  • A Phase II trial in patients with diabetic nephropathy, conducted by Lilly, was initiated in August 2012, and results are expected in 2014.

INCB28060 (also known as INC280) – a c-MET Inhibitor
  • The initial Phase I trial in patients with solid tumors is nearing completion. This compound is licensed to Novartis as part of the Incyte-Novartis collaboration, and further development will be conducted by Novartis.

INCB24360 – an Indoleamine Dioxygenase-1 (IDO1) Inhibitor
  • INCB24360 is currently in Phase I/II clinical development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer.

Early-Stage Development and Discovery Programs
  • Several early development and discovery programs in oncology and inflammation are also ongoing.

Conference Call Information

Incyte will hold its third-quarter 2012 financial results conference call this morning at 8:30 a.m. ET. To access the conference call, please dial 877-407-8037 for domestic callers or 201-689-8037 for international callers. When prompted, provide the conference identification number, 401502.

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