ABRAXANE® Plus Gemcitabine Demonstrates Significant Survival Advantage in Phase III Study of Patients with Advanced Pancreatic

  ABRAXANE® Plus Gemcitabine Demonstrates Significant Survival Advantage in
  Phase III Study of Patients with Advanced Pancreatic Cancer

Abraxane plus gemcitabine was superior to gemcitabine alone with statistically
significant and clinically meaningful results across primary and key secondary
                       endpoints and patient subgroups

       Oral Presentation Scheduled for Friday, January 25^th at ASCO’s
              Gastrointestinal Cancers Symposium Annual Meeting

Business Wire

BOUDRY, Switzerland -- January 22, 2013

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:
CELG), today announced that its phase III clinical trial of ABRAXANE^®
(paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
in combination with gemcitabine in treatment-naïve patients with metastatic
pancreatic cancer demonstrated a statistically significant improvement in
overall survival compared to patients receiving gemcitabine alone [(median of
8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study,
ABRAXANE plus gemcitabine demonstrated a 59% increase in one-year survival
(35% vs. 22%, p=0.0002) and demonstrated double the rate of survival at two
years (9% vs. 4%, p=0.02) as compared to gemcitabine alone.

ABRAXANE plus gemcitabine also demonstrated a statistically significant
improvement in key secondary endpoints compared to gemcitabine alone,
including a 31% reduction in the risk of progression or death with a median
progression-free survival (PFS) of 5.5 vs. 3.7 months (HR 0.69, P=0.000024)
and an overall response rate (ORR) of 23% compared to 7% (response rate ratio
of 3.19, p=1.1 x 10^-10). Another endpoint assessed included time to treatment
failure, which was significantly improved with the ABRAXANE combination
compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70,

“The past few decades have brought us very few treatment advances for patients
with advanced pancreatic cancer, which is both deadly and incredibly difficult
to treat with success,” said Daniel D. Von Hoff, M.D., F.A.C.P., lead
principal investigator of the MPACT study and Chief Scientific Officer for
Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and
Physician-In-Chief for the Translational Genomics Research Institute (TGen).
“The fact that Abraxane plus gemcitabine demonstrated an overall survival
benefit, and also did so at one and two years, is a significant step forward
in offering potential new hope for our patients.”

The most common grade ≥ 3 treatment-related adverse events in the study for
ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs.
27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%). In the ABRAXANE plus
gemcitabine arm, the median time to neuropathy improvement was 29 days. There
was no difference in serious life threatening toxicity (4% in each arm).

“We are excited by the results of the Abraxane MPACT study and the potential
this treatment combination may bring to patients with advanced pancreatic
cancer,” said Jean-Pierre Bizzari, M.D., Executive Vice President, Global Head
Hematology & Oncology Clinical Research, Celgene Corporation. “As the largest
phase III real-world clinical trial in advanced pancreatic cancer, the
clinically meaningful findings seen across key study endpoints and patient
subgroups are a reflection of our ongoing commitment to develop innovative new
therapies in critical areas of need.”

Further details of the study will be highlighted in a late-breaking oral
presentation by Dr. Daniel D. Von Hoff:

  *Abstract: LBA #148: Final results of a randomized phase III study of
    weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in
    patients with metastatic adenocarcinoma of the pancreas.  Friday, January
    25^th between 2:00 to 3:30 pm PST at the American Society of Clinical
    Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in San
    Francisco, CA.

Based on the results of the MPACT study, Celgene plans to submit dossiers for
registration in the US and Europe during the first half of 2013 followed by
submissions in other countries/regions during the second half of 2013.

These results are from an investigational phase III study. ABRAXANE is not
currently approved for the treatment of advanced pancreatic cancer.

About the MPACT Study

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a
Celgene-sponsored, open-label, randomized, international study of 861
metastatic pancreatic cancer patients were randomized to receive either
ABRAXANE plus gemcitabine (125 mg/m^2 followed by 1000 mg/m^2 gemcitabine for
3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m^2
administered weekly for 7 weeks followed by a week of rest followed by cycles
of weekly administration for 3 weeks followed by one week of rest). The
primary endpoint for the study is improvement in overall survival. Secondary
endpoints were progression-free survival, and overall response rate determined
by independent radiological review. Other endpoints included progression-free
survival, overall response rate determined by investigator and the safety and
tolerability of this combination in this patient population.

About Advanced Pancreatic Cancer

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest
survival rates among all cancer types. Across all patients with pancreatic
cancer, relative 5-year survival is 6% and is less than 2% for those with
advanced disease. There are two main types of pancreatic cancer -
adenocarcinomas, which accounts for approximately 90% of all pancreatic
cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon
with new cases accounting for only 2.1% of all newly diagnosed cancers.
However, pancreatic cancer is the fourth most common cause of cancer death in
the United States and eighth globally.


ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using
patented nab^® technology. ABRAXANE is formulated with albumin, a human
protein, and is free of solvents.

In the United States, ABRAXANE was first approved in January 2005 for the
treatment of breast cancer after failure of combination chemotherapy for
metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior
therapy should have included an anthracycline unless clinically
contraindicated. ABRAXANE is also approved in the European Union/European
Economic Area (EU/EEA), Canada, Russia, Australia, New Zealand, India, Japan,
South Korea, Sri Lanka, Bhutan, Nepal, United Arab Emirates and China for the
treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the U.S. Food and Drug
Administration for the first-line treatment of locally advanced or metastatic
non-small cell lung cancer, in combination with carboplatin, in patients who
are not candidates for curative surgery or radiation therapy.

For the full prescribing information for ABRAXANE please visit

ABRAXANE is currently in various stages of investigation for the treatment of
the following cancers: pancreatic, metastatic melanoma, bladder, ovarian,and
expanded applications for breast cancer.

U.S. Regulatory Information for Abraxane

ABRAXANE^® for Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin bound) is indicated for the treatment of
breast cancer after failure of combination chemotherapy for metastatic disease
or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have
included an anthracycline unless clinically contraindicated.

ABRAXANE is indicated for the first-line treatment of locally advanced or
metastatic non-small cell lung cancer, in combination with carboplatin, in
patients who are not candidates for curative surgery or radiation therapy.

Important Safety Information

                            WARNING - NEUTROPENIA

  *Do not administer ABRAXANE therapy to patients who have baseline
    neutrophil counts of less than 1,500 cells/mm^3. In order to monitor the
    occurrence of bone marrow suppression, primarily neutropenia, which may be
    severe and result in infection, it is recommended that frequent peripheral
    blood cell counts be performed on all patients receiving ABRAXANE
  *Note: An albumin form of paclitaxel may substantially affect a drug’s
    functional properties relative to those of drug in solution. DO NOT


Neutrophil Counts

  *ABRAXANE should not be used in patients who have baseline neutrophil
    counts of < 1,500 cells/mm^3


  *Patients who experience a severe hypersensitivity reaction to ABRAXANE
    should not be rechallenged with the drug


Hematologic Effects

  *Bone marrow suppression (primarily neutropenia) is dose-dependent and a
    dose-limiting toxicity of ABRAXANE
  *Monitor for myelotoxicity by performing complete blood cell counts
    frequently, including prior to dosing on Day 1 for metastatic breast
    cancer (MBC) and Days 1, 8, and 15 for non-small cell lung cancer (NSCLC)
  *Do not administer ABRAXANE to patients with baseline absolute neutrophil
    counts (ANC) of less than 1,500 cells/mm^3
  *In the case of severe neutropenia (<500 cells/mm^3 for seven days or more)
    during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in
    subsequent courses in patients with either MBC or NSCLC
  *In patients with MBC, resume treatment with every-3-week cycles of
    ABRAXANE after ANC recovers to a level >1,500 cells/mm^3 and platelets
    recover to >100,000 cells/mm^3
  *In patients with NSCLC, resume treatment if recommended at permanently
    reduced doses for both weekly ABRAXANE and every-3-week carboplatin after
    ANC recovers to at least 1,500 cells/mm^3 and platelet count of at least
    100,000 cells/mm^3 on Day 1 or to an ANC of at least 500 cells/mm^3 and
    platelet count of at least 50,000 cells/mm^3 on Days 8 or 15 of the cycle

Nervous System

  *Sensory neuropathy is dose- and schedule-dependent
  *The occurrence of Grade 1 or 2 sensory neuropathy does not generally
    require dose modification
  *If ≥ Grade 3 sensory neuropathy develops, treatment should be withheld
    until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade1
    for NSCLC followed by a dose reduction for all subsequent courses of


  *Severe and sometimes fatal hypersensitivity reactions, including
    anaphylactic reactions, have been reported
  *Patients who experience a severe hypersensitivity reaction to ABRAXANE
    should not be re-challenged with this drug

Hepatic Impairment

  *Because the exposure and toxicity of paclitaxel can be increased with
    hepatic impairment, administration of ABRAXANE in patients with hepatic
    impairment should be performed with caution
  *The starting dose should be reduced for patients with moderate or severe
    hepatic impairment

Albumin (Human)

  *ABRAXANE contains albumin (human), a derivative of human blood

Use in Pregnancy: Pregnancy Category D

  *ABRAXANE can cause fetal harm when administered to a pregnant woman
  *If this drug is used during pregnancy, or if the patient becomes pregnant
    while receiving this drug, the patient should be apprised of the potential
    hazard to the fetus
  *Women of childbearing potential should be advised to avoid becoming
    pregnant while receiving ABRAXANE

Use in Men

  *Men should be advised not to father a child while receiving ABRAXANE


Randomized Metastatic Breast Cancer (MBC) Study

  *The most common adverse reactions (≥20%) with single-agent use of ABRAXANE
    in the MBC study were alopecia (90%), neutropenia (all cases 80%; severe
    9%), sensory neuropathy (any symptoms 71%; severe 10%), abnormal ECG (all
    patients 60%; patients with normal baseline 35%), fatigue/asthenia (any
    47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), AST elevation
    (any 39%), alkaline phosphatase elevation (any 36%), anemia (all cases
    33%; severe 1%), nausea (any 30%; severe 3%), diarrhea (any 27%; severe
    <1%) and infections (24%)
  *Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%)
  *Other adverse reactions of note included vomiting (any 18%; severe 4%),
    renal dysfunction (any 11%; severe 1%), fluid retention (any 10%; severe
    0%); mucositis (any 7%; severe <1%), hepatic dysfunction (elevations in
    bilirubin 7%), hypersensitivity reactions (any 4%; severe 0%),
    thrombocytopenia (any 2%; severe <1%), and injection site reactions (<1%).
    In all ABRAXANE treated patients (n=366) ocular/visual disturbances were
    reported (any 13%; severe 1%). Dehydration and pyrexia were also reported
  *Severe cardiovascular events possibly related to single-agent ABRAXANE
    occurred in approximately 3% of patients and included cardiac
    ischemia/infarction, chest pain, cardiac arrest, supraventricular
    tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary
    emboli, and hypertension
  *Cases of cerebrovascular attacks (strokes) and transient ischemic attacks
    have been reported

Non-Small Cell Lung (NSCLC) Cancer Study

  *Adverse reactions with a difference of ≥2%, Grade 3 or higher, with
    combination use of ABRAXANE and carboplatin in NSCLC were: anemia (28%);
    neutropenia (47%); thrombocytopenia (18%), and peripheral neuropathy (3%)
  *The most common adverse reactions (≥ 20%) of ABRAXANE in combination with
    carboplatin for NSCLC were anemia, neutropenia, thrombocytopenia,
    alopecia, peripheral neuropathy, nausea, and fatigue
  *The most common serious adverse reactions of ABRAXANE in combination with
    carboplatin for NSCLC were anemia (4%) and pneumonia (3%)
  *The most common adverse reactions resulting in permanent discontinuation
    of ABRAXANE were neutropenia (3%), thrombocytopenia (3%), and periopheral
    neuropathy (1%)
  *The most common adverse reactions resulting in dose reduction of ABRAXANE
    were neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
  *The most common adverse reactions leading to withholding or delay in
    ABRAXANE dosing were neutropenia (41%), thrombocytopenia (30%), and anemia
  *The following common (≥10% incidence) adverse reactions were observed at a
    similar incidence in ABRAXANE plus carboplatin-treated and paclitaxel
    injection plus carboplatin-treated patients: alopecia 56%, nausea 27%,
    fatigue 25%, decreased appetite 17%, asthenia 16%, constipation 16%,
    diarrhea 15%, vomiting 12%, dyspnea 12%, and rash 10% (incidence rates are
    for the ABRAXANE plus carboplatin treatment group)

Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations

  *Severe and sometimes fatal hypersensitivity reactions have been reported
    with ABRAXANE. The use of ABRAXANE in patients previously exhibiting
    hypersensitivity to paclitaxel injection or to human albumin has not been
  *There have been reports of congestive heart failure and left ventricular
    dysfunction with ABRAXANE, primarily among individuals with underlying
    cardiac history or prior exposure to cardiotoxic drugs
  *There have been reports of extravasation of ABRAXANE. Given the
    possibility of extravasation, it is advisable to monitor closely the
    ABRAXANE infusion site for possible infiltration during drug


  *Caution should be exercised when administering ABRAXANE concomitantly with
    medicines known to inhibit or induce either CYP2C8 or CYP3A4


Nursing Mothers

  *It is not known whether paclitaxel is excreted in human milk. Because many
    drugs are excreted in human milk and because of the potential for serious
    adverse reactions in nursing infants, a decision should be made to
    discontinue nursing or to discontinue the drug, taking into account the
    importance of the drug to the mother


  *The safety and efficacy of ABRAXANE in pediatric patients have not been


  *No toxicities occurred notably more frequently among patients ≥ 65 years
    of age who received ABRAXANE for MBC
  *Myelosuppression, peripheral neuropathy, and arthralgia were more frequent
    in patients ≥65 years of age treated with ABRAXANE and carboplatin in

Renal Impairment

  *The use of ABRAXANE has not been studied in patients with renal impairment


  *Dose adjustment is recommended for patients with moderate and severe
    hepatic impairment and patients who experience severe neutropenia or
    severe sensory neuropathy during treatment with ABRAXANE
  *Withhold ABRAXANE if AST >10 x ULN or bilirubin > 5 x ULN
  *Dose reductions or discontinuation may be needed based on severe
    hematologic or neurologic toxicities
  *Monitor patients closely

Please see full Prescribing Information, including Boxed WARNING,

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.


For Celgene International Sàrl
+41 32 729 8303 ir@celgene.com
+41 32 729 8304 media@celgene.com
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