Bristol-Myers Squibb to Present New Investigational Data on Orencia® (abatacept) at the 2012 American College of Rheumatology

  Bristol-Myers Squibb to Present New Investigational Data on Orencia®
  (abatacept) at the 2012 American College of Rheumatology Annual Scientific

  *One year results from AMPLE, first head-to-head Phase III clinical trial
    comparing subcutaneous (SC) Orencia to Humira^® (adalimumab), both in
    combination with methotrexate, to be highlighted as a plenary podium
  *New patient reported outcomes data from the AMPLE trial also to be
  *Orencia IV data will be presented in juvenile idiopathic arthritis and in
    mild relapsing granulomatosis with polyangiitis (Wegener’s)

Business Wire

PRINCETON, N.J. -- November 08, 2012

Bristol-Myers Squibb Company (NYSE: BMY) today announced that new data from
company-sponsored studies on Orencia SC in patients with rheumatoid arthritis
(RA) and Orencia IV in juvenile idiopathic arthritis (JIA) will be presented
at the American College of Rheumatology (ACR) Annual Scientific Meeting in
Washington, D.C., November 10-14. Data from the company-sponsored studies will
include new results from the AMPLE study examining changes in patient reported
outcomes (PROs), including patient pain, patient global assessment and
fatigue, and measures of remission. AMPLE (Abatacept Versus Adalimumab
Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background
Methotrexate) is a head-to-head Phase III non-inferiority clinical trial
comparing subcutaneous (SC) Orencia to Humira^® (adalimumab), each on a
background of methotrexate. Additionally, investigator sponsored research,
supported by BMS, studying Orencia IV in mild relapsing granulomatosis with
polyangiitis (Wegener’s) will be presented.

Other new data being presented on Orencia include:

  *A first report of pooled safety data in Orencia SC & IV formulations based
    on the exposure of more than 6,000 patients, which examines the incidence
    rates and events reported with long-term Orencia treatment.
  *Long-term safety and efficacy of Orencia IV in pediatric patients 6 years
    of age and older with moderately to severely active polyarticular JIA,
    with results including up to seven years of follow-up.
  *Analysis of the onset of treatment response and magnitude of efficacy
    improvement with Orencia SC over six months, with or without an
    intravenous Orencia loading dose.

“The one-year AMPLE results offer a more extensive and in-depth comparative
analysis than previously reported between Orencia SC and Humira, and the
patient reported outcomes continue to expand our understanding Orencia in
moderate to severe RA,” said Brian Daniels, M.D., senior vice president,
Global Development and Medical Affairs, Bristol-Myers Squibb. “The breadth of
data at ACR is an example of our commitment to patients and to our continued
research in RA and other diseases.”

Company-sponsored studies presented at the ACR Annual Scientific Meeting are
shown below. Abstracts can be accessed on the ACR website at

Key Orencia Data in Oral/Poster Presentations:

Session Date,
Time, Location
(all at Walter E.   Presentation Title            Lead Author
Convention Center)
Sunday, November
9:00 AM – 6:00 PM    Subcutaneous Abatacept:        M. Genovese
                     Long-Term Data From the
                    ACQUIRE Trial                  Palo Alto, CA

Location: Poster
Hall (Hall B)
Sunday, November
11                   Real-World Efficacy and
9:00 AM – 6:00 PM    Safety of Abatacept            H. Nüßlein
                     Treatment for Rheumatoid
                    Arthritis: 12-Month Interim    Erlangen, Germany
                     Analysis of the ACTION Study
Location: Poster
Hall (Hall B)
Sunday, November
4:30 PM – 6:00 PM    Assessment of OMERACT Global
                     Power Doppler
                    Ultrasonography 44-Joint
                     Scoring System and Reduced     M.A. D'Agostino
Oral Presentation    Joint Scoring Systems in       Boulogne-Billancourt,
time: 5:15 PM –      Rheumatoid Arthritis           France
5:30 PM              Patients Treated with
                     Abatacept Plus Background

Location: Salon B
Sunday, November
4:30 PM – 6:00 PM    The Relationship Between
                     Power Doppler
                    Ultrasonography Outcomes and
                     Clinical Efficacy in           M.A. D'Agostino
Oral presentation    Abatacept-Treated Patients     Boulogne-Billancourt,
time: 5:30 PM –      with Rheumatoid Arthritis      France
5:45 PM              and in Inadequate Response
                     to Methotrexate

Location: Salon B
Monday, November     Effects of SC Abatacept or
12                   Adalimumab on Remission and
9:00 AM – 6:00 PM    Associated Changes in
                     Physical Function and          R. Fleischmann, Dallas, TX
                    Radiographic Outcomes: One
                     Year Results from the AMPLE
Location: Poster     Trial
Hall (Hall B)
Monday, November
12                   Changes in Patient Reported
9:00 AM – 6:00 PM    Outcomes in Response to
                     Subcutaneous Abatacept or      R. Fleischmann, Dallas, TX
                    Adalimumab in Rheumatoid
                     Arthritis: Results from the
Location: Poster     AMPLE Trial
Hall (Hall B)
Monday, November
4:30 PM – 6:00 PM
                     Cumulative Long-Term Safety
                    and Efficacy of Abatacept in   D. Lovell
                     Children with Juvenile
Presentation time:   Idiopathic Arthritis:          Cincinnati, OH
5:15 PM – 5:30 PM    Results up to 7 Years of

Location: 207 A
Monday, November
12                   Prolonged Exposure to
4:30 PM – 6:00 PM    Subcutaneous and Intravenous
                     Abatacept in Patients with
                    Rheumatoid Arthritis Does      M. Genovese
                     Not Affect Rates of
Presentation time:   Infection, Malignancy and      Palo Alto, CA
4:45 PM – 5:00 PM    Autoimmune Events: Results
                     From Pooled Clinical Trial

Location: Hall E
Tuesday, November
11:00 AM – 12:30
                     Subcutaneous Abatacept
                    versus Adalimumab in the       M. Weinblatt
                     Treatment of Rheumatoid
Presentation time:   Arthritis: 1 Year Results      Boston, MA
11:00 AM – 11:15     from the AMPLE Trial

Location: Hall E
Tuesday, November
4:30 PM – 6:00 PM    Weekly Subcutaneous
                     Abatacept Confers Comparable
                    Onset of Treatment Response    M. Schiff
                     and Magnitude of Efficacy
Presentation time:   Improvement Over 6 Months      Denver, CO
5:00 PM – 5:15 PM    When Administered with or
                     without an Intravenous
                    Abatacept Loading Dose

Location: Hall E

About Orencia ^® (abatacept)

Orencia SC and IV are indicated for reducing signs and symptoms, inducing
major clinical response, inhibiting the progression of structural damage, and
improving physical function in adult patients with moderately to severely
active rheumatoid arthritis. Orencia may be used as monotherapy or
concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than
tumor necrosis factor (TNF) antagonists.

Orencia IV is indicated for reducing signs and symptoms in pediatric patients
6 years of age and older with moderately to severely active polyarticular
juvenile idiopathic arthritis. Orencia IV may be used as monotherapy or
concomitantly with methotrexate (MTX). Orencia SC has not been studied in
pediatric patients. Orencia should not be administered concomitantly with TNF

Orencia is not recommended for use concomitantly with other biologic
rheumatoid arthritis (RA) therapy, such as anakinra.

Orencia is intended for use under the guidance of a physician or healthcare

Important Safety Information

Concomitant Use with TNF antagonists: Concurrent therapy with ORENCIA and a
biologic DMARD is not recommended. In controlled clinical trials, adult
patients receiving concomitant intravenous ORENCIA ^ and TNF antagonist
therapy experienced more infections (63%) and serious infections (4.4%)
compared to patients treated with only TNF antagonists (43% and 0.8%,
respectively), without an important enhancement of efficacy.

Hypersensitivity: Less than 1% of adult patients treated with ORENCIA
experienced hypersensitivity reactions, including some cases of anaphylaxis or
anaphylactoid reactions. Other events potentially associated with drug
hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred
in less than 0.9% of patients treated with ORENCIA^® (abatacept) ^ and
generally occurred within 24 hours of infusion. There was 1 case of a
hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n =190).
Appropriate medical support measures for treating hypersensitivity reactions
should be available for immediate use in the event of a reaction.

Infections: Serious infections, including sepsis and pneumonia, have been
reported in patients receiving ORENCIA. Some of these infections have been
fatal. Many of the serious infections have occurred in patients on concomitant
immunosuppressive therapy which in addition to their underlying disease, could
further predispose them to infection. Caution should be exercised in patients
with a history of infection or underlying conditions which may predispose them
to infections. Treatment with ORENCIA should be discontinued if a patient
develops a serious infection. Patients should be screened for tuberculosis,
and viral hepatitis in accordance with published guidelines, and if positive,
treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or
within 3 months of its discontinuation as it may blunt the effectiveness of
some immunizations. It is recommended that JIA patients be brought up to date
with all immunizations in agreement with current immunization guidelines prior
to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD
patients treated with ORENCIA developed adverse events more frequently than
those treated with placebo (97% vs. 88%, respectively). Respiratory disorders
occurred more frequently in patients treated with ORENCIA compared to those on
placebo (43% vs. 24%, respectively), including COPD exacerbations, cough,
rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA
developed a serious adverse event compared to those on placebo (27% vs. 6%),
including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37
patients (3%)]. Use of ORENCIA in patients with RA and COPD should be
undertaken with caution, and such patients monitored for worsening of their
respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains
maltose, which may result in falsely elevated blood glucose readings on the
day of infusion when using blood glucose monitors with test strips utilizing
glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ). Consider using
monitors and advising patients to use monitors that do not react with maltose,
such as those based on glucose dehydrogenase nicotine adenine dinucleotide
(GDH-NAD), glucose oxidase, or glucose hexokinase test methods. ^ ORENCIA for
subcutaneous administration does not contain maltose; therefore, patients do
not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA^® (abatacept) should be used during
pregnancy only if clearly needed. The risk for development of autoimmune
diseases in humans exposed in utero to abatacept has not been determined.
Nursing mothers should be informed of the risk/benefit of continued
breast-feeding or discontinuation of the drug. A pregnancy registry has been
established to monitor fetal outcomes. Healthcare professionals are encouraged
to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs. 1.9%
placebo) and malignancies (1.3% ORENCIA vs. 1.1% placebo). In general, adverse
events in pediatric and adolescent patients were similar in frequency and type
to those seen in adult patients.

Malignancies: The overall frequency of malignancies was similar between adult
patients treated with ORENCIA or placebo. However, more cases of lung cancer
were observed in patients treated with ORENCIA (0.2%) than those on placebo
(0%). A higher rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active disease, are
at a higher risk for the development of lymphoma. The potential role of
ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract
infection, nasopharyngitis, and nausea were the most commonly reported adverse
events in the adult RA clinical studies.

For US Full Prescribing Information, visit

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease
characterized by inflammation in the lining of joints (or synovium), causing
joint damage with chronic pain, stiffness, swelling and fatigue. RA causes
limited range of motion and decreased joint function. The condition is more
common in women than in men, who account for 75% of patients diagnosed with

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed to
discovering, developing and delivering innovative medicines that help patients
prevail over serious diseases.

For more information about Bristol-Myers Squibb, visit, or follow
us on Twitter at

Orencia is a registered trademark of Bristol-Myers Squibb Company. All other
trademarks are property of their respective owners.


Bristol-Myers Squibb Company
Ken Dominski, +1 609-252-5251
John Elicker, +1 609-252-4611
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