New Data for Jakafi® (ruxolitinib) Presented at the 2012 American Society of Hematology Annual Meeting

  New Data for Jakafi® (ruxolitinib) Presented at the 2012 American Society of
  Hematology Annual Meeting

  *In long-term results from two randomized Phase III clinical trials
    (COMFORT-I and COMFORT-II), patients with myelofibrosis treated with
    Jakafi had improved survival over placebo and best available therapy,
    suggesting an overall survival benefit
  *Data from an ongoing Phase II trial suggest that long-term treatment with
    Jakafi may be a durably efficacious therapy for patients with polycythemia
    vera

 Incyte to host a webcast for investors featuring key results on Monday, Dec.
                             10, at 8:45 p.m. EST

Business Wire

ATLANTA -- December 10, 2012

Incyte Corporation (Nasdaq: INCY) announced today that several analyses from
clinical studies of Jakafi^® (ruxolitinib) were presented at the 2012 American
Society of Hematology (ASH) Annual Meeting from Dec. 8 to 11 at the Georgia
World Congress Center in Atlanta. Jakafi, an oral Janus kinase (JAK)
inhibitor, is FDA-approved for the treatment of patients with intermediate or
high-risk myelofibrosis (MF).

Of 24 Jakafi-related abstracts accepted for presentation at ASH, six are oral
presentations. Two of the oral presentations highlight long-term results from
both COMFORT-I and COMFORT-II in which patients with MF treated with Jakafi
had improved survival over placebo and best available therapy, suggesting an
overall survival benefit in patients with intermediate or high-risk MF.
Additionally, data from this longer-term two-year follow-up show that
improvements in quality of life measures and reductions in spleen volume were
maintained with continued treatment.

Other data presented at ASH include 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 response rates by modified European
Leukemia Net criteria and improvements in PV-related symptoms.

“The long-term data for Jakafi continue to demonstrate tangible benefits for
patients with myelofibrosis, including better management of this progressive
and debilitating disease and an apparent improvement in overall survival,”
stated Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia,
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
in Houston. “In addition, the three-year results from the Phase II trial of
ruxolitinib in patients with polycythemia vera who are resistant to or
intolerant of hydroxyurea are promising, and I look forward to seeing the
Phase III data and the potential to use ruxolitinib to treat patients with
PV.”

“In addition to the promising overall survival data from the two COMFORT
trials, exploratory analyses of the COMFORT-I trial provided additional
guidance on dose titration. We’re confident this information will help
physicians find the optimal dose for each patient and maintain long-term
treatment with Jakafi, providing the potential for longer survival,” said
Richard Levy, M.D., Incyte’s Chief Drug Development and Medical Officer.

Highlights of Key Data Presented

  *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.
  *Cervantes, F, et al. Long-term safety, efficacy, and survival findings
    from COMFORT-II, a Phase III study comparing ruxolitinib with best
    available therapy for the treatment of myelofibrosis.

In two Phase III randomized clinical studies, COMFORT-I and COMFORT-II, Jakafi
was associated with a survival advantage over placebo and best available
therapy, respectively. In COMFORT-I, reductions in spleen volume continued to
be observed over two years of treatment. Spleen volume was reduced by 32
percent at week 24 with Jakafi treatment, and this reduction was sustained
through week 96. Improvements in quality of life measures also continued to be
observed over two years of treatment. Additionally, rates of grade 3 or 4
anemia and thrombocytopenia decreased with long-term therapy, and there was no
apparent change in the frequency or severity of non-hematologic adverse
events.

Survival analyses were conducted at a two-year follow-up in COMFORT-I and
COMFORT-II, comparing patients randomized to Jakafi with those randomized to
placebo and best available therapy, respectively. In COMFORT-I, Jakafi
continued to be associated with a survival advantage over placebo. There were
27 deaths in the group treated with Jakafi, and 41 in the placebo group,
representing a HR=0.58 (95% CI, 0.36-0.95; P = 0.028). Overall survival
favored treatment with Jakafi regardless of JAK2V617F mutation status.
Similarly, an updated analysis of COMFORT-II suggested longer survival for
patients randomized to Jakafi when compared to those randomized to best
available therapy. In this study, where twice as many patients were randomized
to Jakafi (146) as to placebo (73), there were 14 percent (n=20) deaths in the
group treated with Jakafi and 22 percent (n=16) in the best available therapy
group, representing a HR=0.51 (95% CI, 0.26-0.99; P = 0.041). These survival
benefits were observed even though all patients in the placebo and best
available therapy groups continuing in the COMFORT studies were switched to
Jakafi treatment soon after the primary analyses, suggesting that earlier
initiation of treatment with Jakafi may have contributed to longer survival.

The slides used during the presentations can be accessed at: 2012 ASH
Oral_Verstovsek_C-I and 2012 ASH Oral_Cervantes_C-II.

  *Verstovsek, S, et al. Long-term efficacy and safety results from a Phase
    II study of ruxolitinib in patients with polycythemia vera.

In a Phase II clinical trial of patients (n=34) with polycythemia vera (PV)
who are resistant or intolerant to hydroxyurea, ruxolitinib treatment resulted
in clinical benefit by providing durable overall response rates by modified
European Leukemia Net criteria as well as ameliorating symptoms commonly
associated with PV, such as itching, night sweats and bone pain. Overall
response was achieved in 97 percent of patients at week 24. Of these
responders, 74 percent maintained overall response at week 144. Anemia and
thrombocytopenia (primarily grade 1) were the most common adverse events.

The slides used during the presentation can be accessed at: 2012 ASH
Oral_Verstovsek_PV.

Other data related to Jakafi presented orally at ASH include:

  *Talpaz, M, et al. Efficacy, hematologic effects, and dose of ruxolitinib
    in myelofibrosis patients with low starting platelet counts (50–100 x
    10^9/L): A comparison to patients with normal or high starting platelet
    counts. 2012 ASH Oral_Talpaz
  *Harrison, C, et al. EXPAND: a Phase 1b, open-label, dose-finding study of
    ruxolitinib in patients with myelofibrosis and baseline platelet counts
    between 50 × 10^9/L and 99 × 10^9/L. 2012 ASH Oral_Harrison
  *Vannucchi, A, et al. Reductions in JAK2 V617F allele burden with
    ruxolitinib treatment in COMFORT-II, a Phase III study comparing the
    safety and efficacy of ruxolitinib with best available therapy. 2012 ASH
    Oral_Vannucchi

The following presentations related to Jakafi were exhibited during poster
sessions at ASH:

  *Mesa, R, et al. Clinical benefits of ruxolitinib therapy in myelofibrosis
    patients with varying degrees of splenomegaly and symptoms. 2012 ASH
    Poster #1727
  *Mesa, R, et al. Improvement in weight and total cholesterol and their
    association with survival in ruxolitinib-treated patients with
    myelofibrosis from COMFORT-I. 2012 ASH Poster #1733
  *McMullin, M, et al. The use of erythropoietic-stimulating agents with
    ruxolitinib in patients with primary myelofibrosis, post-polycythemia vera
    myelofibrosis, and post-essential thrombocythemia myelofibrosis. 2012 ASH
    Poster #2838
  *Verstovsek, S, et al. Effect of ruxolitinib on the incidence of
    splenectomy in patients with myelofibrosis: A retrospective analysis of
    data from ruxolitinib clinical trials. 2012 ASH Poster #2847
  *Ouagari, K, et al. Cost-effectiveness of ruxolitinib versus best-available
    therapy for medical treatment of myelofibrosis: Canadian societal
    perspective. 2012 ASH Poster #4255
  *Barosi, G, et al. An individual patient supply program for ruxolitinib for
    the treatment of patients with primary myelofibrosis, post-polycythemia
    vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. 2012
    ASH Poster #2844

About the Webcast

Incyte will host an investor meeting to discuss the new Jakafi data being
presented at ASH. The presentation will be webcast live at 8:45 p.m. EST on
December 10, 2012, and can be accessed at www.incyte.com under Investor
Relations, Events and Webcasts. A replay of the event will be available for 60
days.

About Jakafi

Jakafi is a prescription medicine used to treat people with intermediate or
high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF
and post–essential thrombocythemia MF.

Important Safety Information

  *Treatment with Jakafi can cause hematologic adverse reactions, including
    thrombocytopenia, anemia and neutropenia, which are each dose-related
    effects, with the most frequent being thrombocytopenia and anemia. A
    complete blood count must be performed before initiating therapy with
    Jakafi. Complete blood counts should be monitored as clinically indicated
    and dosing adjusted as required. The three most frequent non-hematologic
    adverse reactions were bruising, dizziness and headache
  *Patients with platelet counts <200 × 10^9/L at the start of therapy are
    more likely to develop thrombocytopenia during treatment. Thrombocytopenia
    was generally reversible and was usually managed by reducing the dose or
    temporarily withholding Jakafi. If clinically indicated, platelet
    transfusions may be administered
  *Patients developing anemia may require blood transfusions. Dose
    modifications of Jakafi for patients developing anemia may also be
    considered
  *Neutropenia (ANC <0.5 × 10^9/L) was generally reversible and was managed
    by temporarily withholding Jakafi
  *Patients should be assessed for the risk of developing serious bacterial,
    mycobacterial, fungal and viral infections. Active serious infections
    should have resolved before starting Jakafi. Physicians should carefully
    observe patients receiving Jakafi for signs and symptoms of infection
    (including herpes zoster) and initiate appropriate treatment promptly
  *A dose modification is recommended when administering Jakafi with strong
    CYP3A4 inhibitors or in patients with renal or hepatic impairment [see
    Dosage and Administration]. Patients should be closely monitored and the
    dose titrated based on safety and efficacy
  *There are no adequate and well-controlled studies of Jakafi in pregnant
    women. Use of Jakafi during pregnancy is not recommended and should only
    be used if the potential benefit justifies the potential risk to the fetus
  *Women taking Jakafi should not breast-feed. Discontinue nursing or
    discontinue the drug, taking into account the importance of the drug to
    the mother

For Full Prescribing Information for Jakafi, visit www.Jakafi.com.

About the Incyte-Novartis Worldwide Collaboration and License Agreement

In 2009, Incyte entered into a worldwide collaboration and license agreement
with Novartis. Incyte retained exclusive rights for the development and
potential commercialization of ruxolitinib in all hematology-oncology
indications in the US. Novartis received exclusive rights to the development
and potential commercialization of ruxolitinib in all hematology-oncology
indications outside of the US. Incyte received FDA approval of Jakafi for the
treatment of patients with intermediate or high-risk myelofibrosis in November
2011, and in August 2012 Novartis announced that ruxolitinib, marketed as
Jakavi® outside the United States, received approval from the European
Commission for the treatment of disease-related splenomegaly or symptoms in
adult patients with primary MF, post-polycythemia vera MF or post-essential
thrombocythemia MF.

COMFORT-I was conducted by Incyte in the United States, Canada and Australia.
COMFORT-II was conducted by Novartis in Europe.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company
focused on the discovery, development and commercialization of proprietary
small molecule drugs for oncology and inflammation. For additional information
on Incyte, please visit the Company's website at www.incyte.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth
in this press release, including statements with respect to the potential
efficacy, safety and therapeutic value of Jakafi® (ruxolitinib), including
statements that there may be an overall survival benefit, or advantage or
improvement with treatment with Jakafi, that earlier initiation of treatment
with Jakafi may contribute to longer survival, that additional guidance on
dose titration may provide information to help physicians find the optimal
dose for each patient and maintain long-term treatment with Jakafi, providing
the potential for longer survival, and the potential use of ruxolitinib to
treat patients with polycythemia vera, contain predictions and estimates and
are forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements are subject to risks and uncertainties that
may cause actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of Jakafi, the
results of further research and development, the high degree of risk and
uncertainty associated with drug development and clinical trials, and other
risks detailed from time to time in Incyte's filings with the Securities and
Exchange Commission, including its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2012. Incyte disclaims any intent or obligation to
update these forward-looking statements.

Links to third party websites or pages are provided for convenience only. Each
website is subject to its own terms of use, and Incyte encourages you to
consult these policy statements. Incyte has no control over third party sites
and does not endorse or recommend these sites, and expressly disclaims any
responsibility for the accuracy of content or opinions set forth in any third
party website or your use of that information.

Contact:

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944