Celgene Provides REVLIMID® Regulatory Update

  Celgene Provides REVLIMID® Regulatory Update

     REVLIMID Granted Approval for Treatment of Patients with Relapsed or
                     Refractory Multiple Myeloma in China

 REVLIMID Granted Priority Review as Treatment for Patients with Relapsed or
  Refractory Mantle Cell Lymphoma- U.S. FDAPDUFA Date Set for June 5, 2013

Business Wire

BOUDRY, Switzerland -- February 11, 2013

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:
CELG), today announced that REVLIMID^® (lenalidomide) has been granted full
approval, which includes an Import Drug License (IDL) by the China State Food
and Drug Administration (SFDA) for use in combination with dexamethasone as a
treatment for patients with relapsed or refractory multiple myeloma who have
received at least one prior therapy.

The approval of REVLIMID is based upon the safety and efficacy results of
multiple pivotal randomized phase III international clinical trials in
patients with relapsed or refractory multiple myeloma. Results from a large,
phase II bridging study (MM-021) of lenalidomide and low-dose dexamethasone in
159 Chinese patients, who had relapsed or refractory multiple myeloma, also
supported the submission and approval.

Multiple myeloma is the second most commonly diagnosed blood cancer. According
to the International Myeloma Foundation, there are an estimated 750,000 people
with multiple myeloma worldwide.

REVLIMID will be available only through a proprietary distribution program
developed by Celgene. The company is working to supply REVLIMID to the China
market as soon as possible. Certain standard government processes must be
followed prior to launch. Celgene expects REVLIMID to be available to patients
late in the second quarter of 2013.

U.S. Food and Drug Administration (FDA) Priority Review

Celgene was also informed that its application for REVLIMID in patients with
relapsed or refractory mantle cell lymphoma (MCL) after prior therapy that
included bortezomib has been accepted by the U.S. Food and Drug
Administration. The agency has assigned a priority review to the application
and has set a Prescription Drug User Fee Act date of June 5, 2013.

About REVLIMID

REVLIMID is approved in combination with dexamethasone for the treatment of
patients with multiple myeloma who have received at least one prior therapy in
nearly 70 countries, encompassing Europe, the Americas, the Middle-East and
Asia, and in combination with dexamethasone for the treatment of patients
whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland,
Australia, New Zealand and several Latin American countries, as well as
Malaysia and Israel, for transfusion-dependent anaemia due to low- or
intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality
with or without additional cytogenetic abnormalities. Marketing Authorization
Applications are currently being evaluated in a number of other countries.

U.S. Regulatory Information for Revlimid

REVLIMID^® (lenalidomide) in combination with dexamethasone is indicated for
the treatment of patients with multiple myeloma (MM) who have received at
least one prior therapy.

REVLIMID^® (lenalidomide) is indicated for the treatment of patients with
transfusion-dependent anemia due to low- or intermediate-1–risk
myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic abnormalities.

Important Safety Information

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND
PULMONARY EMBOLISM

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue,
caused limb abnormalities in a developmental monkey study. Thalidomide is a
known human teratogen that causes severe life-threatening human birth defects.
If lenalidomide is used during pregnancy, it may cause birth defects or death
to a developing baby. In women of childbearing potential, obtain 2 negative
pregnancy tests before starting REVLIMID treatment. Women of childbearing
potential must use 2 forms of contraception or continuously abstain from
heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid
fetal exposure to lenalidomide, REVLIMID is only available in the U.S. under a
restricted distribution program called “RevAssist^®.”

Information about the RevAssist program is available at www.REVLIMID.com or by
calling the manufacturer’s toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty
percent of patients with del 5q MDS had to have a dose delay/reduction during
the major study. Thirty-four percent of patients had to have a second dose
delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients
enrolled in the study. Patients on therapy for del 5q MDS should have their
complete blood counts monitored weekly for the first 8 weeks of therapy and at
least monthly thereafter. Patients may require dose interruption and/or
reduction. Patients may require use of blood product support and/or growth
factors. (see DOSAGE and ADMINISTRATION)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

REVLIMID has demonstrated a significantly increased risk of deep vein
thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who were
treated with REVLIMID and dexamethasone therapy. Patients and physicians are
advised to be observant for the signs and symptoms of thromboembolism.
Patients should be instructed to seek medical care if they develop symptoms
such as shortness of breath, chest pain, or arm or leg swelling. It is not
known whether prophylactic anticoagulation or antiplatelet therapy prescribed
in conjunction with REVLIMID may lessen the potential for venous
thromboembolic events. The decision to take prophylactic measures should be
done carefully after an assessment of an individual patient’s underlying risk
factors.

CONTRAINDICATIONS:

Pregnancy Category X:

  *Lenalidomide is contraindicated in pregnant women and women capable of
    becoming pregnant. Females of childbearing potential may be treated with
    lenalidomide provided adequate precautions are taken to avoid pregnancy

Allergic Reactions:

  *REVLIMID is contraindicated in patients who have demonstrated
    hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
    epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS:

Fetal Risk:

  *REV may cause fetal harm when administered to a pregnant woman
  *REVLIMID is an analogue of thalidomide, a known human teratogen that
    causes life-threatening human birth defects. An embryofetal development
    study in non-human primates indicates that lenalidomide produced
    malformations in the offspring of female monkeys who received the drug
    during pregnancy, similar to birth defects observed in humans following
    exposure to thalidomide during pregnancy. If REVLIMID is used during
    pregnancy, it may cause birth defects or death to a developing baby
  *Females of childbearing potential must be advised to avoid pregnancy while
    on REVLIMID. Two effective contraceptive methods must be used by female
    patients of childbearing potential for at least 4 weeks before beginning
    REVLIMID therapy, during therapy, during dose interruptions and for 4
    weeks following discontinuation of REVLIMID therapy
  *Male Patients: Clinical data has demonstrated the presence of lenalidomide
    in human semen. Male patients taking REVLIMID should not donate sperm.
    Males receiving REVLIMID must always use a latex condom during any sexual
    contact with females of childbearing potential, even if they have
    undergone a successful vasectomy

Reproductive Risk and Special Prescribing Requirements (RevAssist Program):

  *Because of this potential toxicity and to avoid fetal exposure, REVLIMID
    is only available under a special restricted distribution program called
    “RevAssist.” Prescribers and pharmacists registered with the program can
    prescribe and dispense the product to patients who are registered and meet
    all the conditions of the RevAssist program

Hematologic Toxicity—Multiple Myeloma:

  *REVLIMID can cause significant neutropenia and thrombocytopenia
  *Patients taking REVLIMID for MM should have their complete blood counts
    monitored every 2 weeks for the first 12 weeks and then monthly thereafter
  *In the pooled MM studies Grade 3 and 4 hematologic toxicities were more
    frequent in patients treated with the combination of REVLIMID and
    dexamethasone than in patients treated with dexamethasone alone
  *Patients may require dose interruption and/or dose reduction

Deep Vein Thrombosis and Pulmonary Embolism:

  *Venous thromboembolic events (predominantly deep venous thrombosis and
    pulmonary embolism) have occurred in patients with MM treated with
    lenalidomide combination therapy and patients with MDS treated with
    lenalidomide monotherapy

Allergic Reactions:

  *Angioedema and serious dermatologic reactions including Stevens-Johnson
    syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported.
    These events can be fatal. Patients with a prior history of Grade 4 rash
    associated with thalidomide treatment should not receive REVLIMID.
    REVLIMID interruption or discontinuation should be considered for Grade
    2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash,
    exfoliative or bullous rash, or if SJS or TEN is suspected, and should not
    be resumed following discontinuation for these reactions
  *REVLIMID capsules contain lactose. Risk-benefit of REVLIMID treatment
    should be evaluated in patients with lactose intolerance

Tumor Lysis Syndrome:

  *Fatal instances of tumor lysis syndrome have been reported during
    treatment with lenalidomide. The patients at risk of tumor lysis syndrome
    are those with high tumor burden prior to treatment. These patients should
    be monitored closely and appropriate precautions taken

Tumor Flare Reaction:

  *Tumor flare reaction has occurred during investigational use of
    lenalidomide for chronic lymphocytic leukemia (CLL) and lymphoma, and is
    characterized by tender lymph node swelling, low grade fever, pain and
    rash. Treatment of CLL or lymphoma with lenalidomide outside of a
    well-monitored clinical trial is discouraged

Hepatotoxicity:

  *Cases of transient liver laboratory abnormalities (predominantly
    transaminases) were reported in patients treated with lenalidomide.
    Treatment with lenalidomide should be interrupted and restarted once the
    levels return to baseline. Successful re-challenge without recurrence of
    liver laboratory elevation was reported in some patients

Second Primary Malignancies

  *Patients with MM treated with lenalidomide in studies including melphalan
    and stem cell transplantation had a higher incidence of second primary
    malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin
    lymphoma, compared to patients in the control arms who received similar
    therapy but did not receive lenalidomide. Monitor patients for the
    development of second malignancies. Take into account both the potential
    benefit of lenalidomide and the risk of second primary malignancies when
    considering treatment with lenalidomide

DRUG INTERACTIONS:

  *Periodic monitoring of digoxin plasma levels, in accordance with clinical
    judgment and based on standard clinical practice in patients receiving
    this medication, is recommended during administration of REVLIMID
  *It is not known whether there is an interaction between dexamethasone and
    warfarin. Close monitoring of PT and INR is recommended in MM patients
    taking concomitant warfarin
  *Erythropoietic agents, or other agents, that may increase the risk of
    thrombosis, such as estrogen containing therapies, should be used with
    caution in MM patients receiving lenalidomide with dexamethasone

USE IN SPECIFIC POPULATIONS:

Nursing Mothers:

  *It is not known whether REVLIMID is excreted in human milk
  *Because of the potential for adverse reactions in nursing infants, a
    decision should be made whether to discontinue nursing or the drug, taking
    into account the importance of the drug to the mother

Geriatric Use:

  *Since elderly patients are more likely to have decreased renal function,
    care should be taken in dose selection Monitor renal function

Renal Impairment:

  *Since REVLIMID is primarily excreted unchanged by the kidney, adjustments
    to the starting dose of REVLIMID are recommended to provide appropriate
    drug exposure in patients with moderate (CLcr 30-60 mL/min) or severe
    renal impairment (CLcr < 30 mL/min) and in patients on dialysis

ADVERSE REACTIONS:

Multiple Myeloma

  *In the REVLIMID/dexamethasone treatment group, 269 patients (76%)
    underwent at least one dose interruption with or without a dose reduction
    of REVLIMID compared to 199 patients (57%) in the placebo/dexamethasone
    treatment group
  *Of these patients who had one dose interruption with or without a dose
    reduction, 76% (269/353) vs 57% (199/350), 50% in the
    REVLIMID/dexamethasone treatment group underwent at least one additional
    dose interruption with or without a dose reduction compared to 21% in the
    placebo/dexamethasone treatment group
  *Most adverse events and Grade 3/4 adverse events were more frequent in MM
    patients who received the combination of REVLIMID/dexamethasone compared
    to placebo/dexamethasone
  *Grade 3/4 neutropenia occurred in 33.4% vs 3.4%; 2.3% experienced Grade
    3/4 febrile neutropenia vs 0%
  *Deep vein thrombosis (DVT) was reported as a serious adverse drug reaction
    (7.4%) or Grade 3/4 (8.2%) compared to 3.1% and 3.4%. Discontinuations due
    to DVT were reported at comparable rates between groups
  *Pulmonary embolism (PE) was reported as a serious adverse drug reaction
    (3.7%) or Grade 3/4 (4.0%) compared to 0.9% and 0.9%. Discontinuations due
    to PE were reported at comparable rates between groups
  *Adverse reactions reported in ≥15% of MM patients (REVLIMID/dexamethasone
    vs dexamethasone/placebo): fatigue (44% vs 42%), neutropenia (42% vs 6%),
    constipation (41% vs 21%), diarrhea (39% vs 27%), muscle cramp (33% vs
    21%), anemia (31% vs 24%), pyrexia (28% vs 23%), peripheral edema (26% vs
    21%), nausea (26% vs 21%), back pain (26% vs 19%), upper respiratory tract
    infection (25% vs 16%), dyspnea (24% vs 17%), dizziness (23% vs 17%),
    thrombocytopenia (22% vs 11%), rash (21% vs 9%), tremor (21% vs 7%),
    weight decreased (20% vs 15%), nasopharyngitis (18% vs 9%), blurred vision
    (17% vs 11%), anorexia (16% vs 10%), and dysgeusia (15% vs 10%)

Myelodysplastic Syndromes

  *Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the
    most frequently reported adverse events observed in the del 5q MDS
    population
  *Grade 3 and 4 adverse events reported in ≥ 5% of patients with del 5q MDS
    were neutropenia (53%), thrombocytopenia (50%), pneumonia (7%), rash (7%),
    anemia (6%), leukopenia (5%), fatigue (5%), dyspnea (5%), and back pain
    (5%)
  *Other adverse events reported in ≥15% of del 5q MDS patients (REVLIMID):
    diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation
    (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia
    (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness
    (20%), headache (20%), muscle cramp (18%), dyspnea (17%), pharyngitis
    (16%), epistaxis (15%), asthenia (15%), upper respiratory tract infection
    (15%)

DOSAGE AND ADMINISTRATION:

  *Treatment is continued or modified based upon clinical and laboratory
    findings. Dosing modifications are recommended to manage Grade 3 or 4
    neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to
    be related to REVLIMID
  *For other Grade 3 or 4 toxicities judged to be related to REVLIMID, hold
    treatment and restart at next lower dose level when toxicity has resolved
    to ≤Grade 2

Please see full Prescribing Information, including Boxed WARNINGS,
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

About Celgene

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel,
Switzerland, is a wholly owned subsidiary and international headquarters of
Celgene Corporation.

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated
global pharmaceutical company engaged primarily in the discovery, development
and commercialization of innovative therapies for the treatment of cancer and
inflammatory diseases through gene and protein regulation. For more
information, please visit the Company's website at www.celgene.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally
statements that are not historical facts. Forward-looking statements can be
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans," "will," “outlook” and similar expressions.
Forward-looking statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are made. We
undertake no obligation to update any forward-looking statement in light of
new information or future events, except as otherwise required by law.
Forward-looking statements involve inherent risks and uncertainties, most of
which are difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of factors,
many of which are discussed in more detail in our Annual Report on Form 10-K
and our other reports filed with the Securities and Exchange Commission.

Contact:

Celgene
Investors:
+41 32 729 8303
ir@celgene.com
Media:
+41 32 729 8304
media@celgene.com
 
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