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Incyte Reports 2012 Second-Quarter Financial Results; Updates Shareholders On Launch Of Jakafi And Lead Clinical Programs

Cash Position

As of June 30, 2012, cash, cash equivalents and marketable securities totaled $261.8 million compared to $277.6 million as of December 31, 2011. These amounts exclude $9.5 million and $19.0 million, respectively, at June 30, 2012, and December 31, 2011, of restricted cash and investments held in an escrow account reserved for interest payments through October 2012 on the 4.75% Convertible Senior Notes.

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 at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and the 17 th Congress of the European Hematology Association (EHA) in Amsterdam.
    • Interim results from an ongoing Phase II study of ruxolitinib in MF patients with baseline platelet counts between 50 X 10 9/L and 100 X 10 9/L support use in these patients.
    • An analysis of COMFORT-I data to evaluate the return of symptoms and assess adverse events upon interruption or discontinuation of treatment with Jakafi demonstrates that discontinuation of Jakafi does not lead to a withdrawal syndrome.
  • Two clinical trials, in partnership with Novartis, are underway to evaluate ruxolitinib in patients with advanced polycythemia vera (PV) with results expected to be part of a supplemental new drug application (sNDA) submission in 2014.
    • A global Phase III trial (known as the RESPONSE trial) evaluating ruxolitinib versus best available therapy in patients with advanced polycythemia vera who are resistant to or intolerant of hydroxyurea continues to enroll patients and is targeted to complete recruitment in the second half of 2012.
    • A randomized Phase III trial (known as the RELIEF trial) comparing disease-related symptoms in patients with polycythemia vera treated with ruxolitinib versus those treated with hydroxyurea is now enrolling patients. This trial is designed to support potential labeling claims on symptomatic benefit.
  • 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 with 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

  • The six-month Phase IIb trial of baricitinib in patients with rheumatoid arthritis, conducted by our collaboration partner Eli Lilly and Company, is complete, and three-month data were presented as a late-breaking oral presentation at the European League Against Rheumatism's (EULAR) Annual European Congress of Rheumatology in Berlin.
    • The trial achieved its primary endpoint by demonstrating a statistically significant difference in the American College of Rheumatology 20 (ACR20) response of the combined 4 mg and 8 mg baricitinib groups (76 percent) compared to placebo (41 percent) after 12 weeks of treatment (p<0.001).
    • Statistically significant improvement was observed after two weeks of treatment, the first assessment point, and was sustained through week 12.
    • The frequency of adverse events, serious adverse events and discontinuation was similar to placebo.
  • The six-month data from the Phase IIb trial are expected to be presented later in 2012.
  • Plans for the Phase III program of baricitinib in patients with rheumatoid arthritis are underway with trials expected to begin in the second half of 2012.
  • A Phase IIb trial in patients with moderate to severe psoriasis, conducted by Lilly, is ongoing with primary endpoint results expected in 2013.

INCB28060 (also known as INC280) – a c-MET Inhibitor

  • The initial Phase I trial in patients with solid tumors, which will identify a pharmacologically active dose, 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

  • Preliminary results from the Phase I clinical trial were presented at the 2012 ASCO Annual Meeting in Chicago.
    • Because IDO1 expression in human tumors is associated with poor prognosis, IDO1 inhibition may provide a new approach to increase survival in patients with a variety of solid tumors.
    • Data from this first Phase I trial demonstrate that INCB024360 achieves greater than 90 percent IDO1 inhibition at generally well-tolerated doses.
  • A Phase II trial in combination with ipilimumab in patients with metastatic melanoma was recently initiated, and a second Phase II trial as monotherapy in patients with ovarian cancer is expected to begin later this year.

Early-Stage Development and Discovery Programs

  • Several early development and discovery programs in oncology and inflammation are also underway.

Conference Call Information

Incyte will hold its second-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, 397266.

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