• First presentation of results from the Phase IIIb AVERT study highlighting induction of remission with Orencia in patients with highly-active early rheumatoid arthritis (RA)
• New data from the two-year head-to-head AMPLE trial, evaluating Orencia vs. Humira(R) (adalimumab) in RA, also to be presented
• Presentation of 24-week efficacy, safety and MRI data from a Phase IIb trial of clazakizumab, an investigational selective IL-6 cytokine inhibitor for RA

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) announced today that 20 abstracts for Orencia^(R) (abatacept), and clazakizumab have been accepted for presentation at the 2014 annual meeting of the European League Against Rheumatism (EULAR), to be held June 11-14 in Paris, France. The extensive data being presented underscores the Company's commitment to develop innovative treatments for patients suffering from rheumatoid arthritis (RA) and other immune-mediated diseases, including its pioneering T-cell co-stimulation modulator, Orencia, and clazakizumab, an investigational selective IL-6 cytokine inhibitor.

"Leveraging our heritage and expertise in immunoscience, Bristol-Myers Squibb remains focused on changing the course of immune-mediated diseases like RA," said Michael Giordano, senior vice president, Head of Development, Oncology and Immunoscience, Bristol-Myers Squibb. "The clinical results and real-world data we will present at the EULAR annual meeting reflect our commitment to develop innovative therapies to improve the health of patients suffering from RA."

The complete list of Bristol-Myers Squibb presentations is below. Abstracts can be accessed on the EULAR website at https://b-com.mci-group.com/AbstractList/EULAR2014.aspx.

Title                                            Date/Time

ORENCIA (Abatacept)

Induction of Clinical Remission Followed by
Drug-free Withdrawal with Abatacept              June 12, 2014 at 10:30 a.m. CET
Combination and Monotherapy in Early RA:
Results from the AVERT Study Over 18 Months

MRI Results from the AVERT Study: A
Randomized, Active-Controlled Trial to
Evaluate Induction of Remission and              June 12, 2014 at 11:10 a.m. CET
Maintenance of Drug-Free Remission Using
Abatacept in Combination with Methotrexate or
as Monotherapy in Patients with Early RA

Modulation of the ACPA Fine Specificity in       June 13, 2014 at
Patients with RA Treated with Either Abatacept
or Adalimumab in the AMPLE Study                 11:45 a.m. CET

Clinical Responses By Baseline RA Disease
Duration in the AMPLE (Abatacept versus          June 13, 2014 at
Adalimumab Comparison in Biologic-Naïve RA
Patients with Background Methotrexate) Trial:    11:45 a.m. CET
2-Year Results

Comparison of Abatacept and Other Biologic
DMARDS for the Treatment of Rheumatoid           June 14, 2014 at 10:15 a.m. CET
Arthritis Patients: A Systemic Literature
Review and Network Meta-Analysis

Correlation of Clinical Response with
Patient-Reported Outcomes in the AMPLE           June 14, 2014 at
(Abatacept versus Adalimumab Comparison in
Biologic-Naïve RA Patients with Background       10:15 a.m. CET
Methotrexate) Trial: 2-Year Results

Association of Radiographic Outcomes with Low
Disease Activity and Remission and               June 13, 2014 at
Sustainability of Response with Subcutaneous
Abatacept or Adalimumab: 2-Year Results from     11:45 a.m. CET
the AMPLE Trial

Two-Year Retention and Effectiveness of          June 13, 2014 at
Abatacept in Real-Life Setting: Results from
the ACTION Study                                 11:45 a.m. CET

Two-Year Retention and Effectiveness of IV
Abatacept Monotherapy and Combination in PTS     June 14, 2014 at
With RA Previously Treated With at Least One
Biologic Agent in a Real-Life Setting:           10:15 a.m. CET
Subgroup Analysis From the ACTION Study

Decreased Use of Glucocorticoids in PTS With     June 14, 2014 at
RA Who Initiated IV Abatacept and Previously
Failed At Least One Biologic Agent: Results      10:15 a.m. CET
From the 2-Year Action Study

Gene Expression in Whole Blood Predicts the
Abatacept-Methotrexate Combination
Responsiveness in Rheumatoid Arthritis:          June 12, 2014 at 11:45 a.m. CET
Preliminary Results From the Power Doppler
Ultrasonography Appraise Study

CLAZAKIZUMAB

A Phase IIB Study of the Efficacy and Safety
of Subcutaneous Clazakizumab (Anti-IL-6
Monoclonal Antibody) With or Without             June 14, 2014 at 10:15 a.m. CET
Methotrexate in Adults With Moderate-to-Severe
Active Rheumatoid Arthritis and an Inadequate
Response to Methotrexate

X-Ray and MRI Results From a Phase IIB Study
of Subcutaneous Anti-Iinterleukin-6 Monoclonal
Antibody Clazakizumab With or Without MTX in
Adults with Moderate-to-Severe Active            June 14, 2014 at 10:15 a.m. CET
Rheumatoid Arthritis and an Inadequate
Response to Conventional DMARDS Including
Methotrexate

Health Economics & Outcomes Research

Differences (or Variations) in Physical
Function in RA By Disease Activity Levels        June 12, 2014 at 11:45 a.m. CET
Defined by DAS, CDAI, and SDAI in Clinical
Practice

Development and Validation of a Prognostic
Clinical Model for Rapid Radiographic            June 14, 2014 at 10:15 a.m. CET
Progression in Patients with RA

The Role of C-Reactive Protein or Erythrocyte
Sedimentation rate in Predicting
Cardiovascular Outcomes in Rheumatoid            June 13, 2014 at 12:00 p.m. CET
Arthritis of Data From US Managed Care
Organization

Quality of Life and Economic Benefits of
Remission/Low Disease Activity in Patients       June 13, 2014 at 11:45 a.m. CET
with Rheumatoid Arthritis in Clinical Practice
Setting

Performance of the Framingham Cardiovascular
Risk Prediction Model With or Without CRP in     June 14, 2014 at 10:15 a.m. CET
RA Patients: Analysis of UK Clinical Practice
Research Data

Performance of the Framingham Cardiovascular
Risk Prediction Model With and Without
C-Reactive Protein or Erythrocyte                June 14, 2014 at 10:15 a.m. CET
Sedimentation Rate in RA: Analysis of US
Electronic Medical Records Database

DISEASE-STATE PRESENTATION

Incidence of Malignancy in Adult Patients with
Rheumatoid Arthritis: An Updated Analysis of     June 12, 2014 at 12:00 p.m. CET
the Literature

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 RA.

About ORENCIA^(R) (abatacept)

ORENCIA SC and IV is 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 antagonists.

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 practitioner.

Indication/Usage and Important Safety Information for ORENCIA^(R) (abatacept)

Indication/Usage

Adult Rheumatoid Arthritis (RA): ORENCIA^(R) (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA), including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA also reduces signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used alone or with methotrexate (MTX).

Important Safety Information About ORENCIA^(R) (abatacept)

Inform your healthcare provider of the following, before you receive treatment with ORENCIA:

Infections: If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a dry cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have Surgery.

Allergies to the Ingredients of ORENCIA^(R)(abatacept): The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby.

Breastfeeding: You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.

If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements.

If you are Taking Other Biologic Medicines to Treat RA such as: Enbrel^(R) (etanercept), Humira^(R) (adalimumab), Remicade^(R) (infliximab), Kineret^(R) (anakinra), Rituxan^(R) (rituximab), Simponi^(R) (golimumab), Cimzia^(R) (certolizumab pegol), Actemra^(R) (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA^(R) (abatacept)

ORENCIA can cause serious side effects including:

    --  Serious infections. ORENCIA can make you more likely to get infections
        or make the infection that you have get worse. Some patients have died
        from these infections. Call your healthcare provider immediately if you
        feel sick or get any of the following signs of infection: fever; feel
        very tired; cough; feel flu-like; or warm, red or painful skin.
    --  Allergic reactions. Allergic reactions can happen on the day of
        treatment or the day after receiving ORENCIA. Tell your healthcare
        provider or get emergency medical help right away if you have hives;
        swollen face, eyelids, lips, or tongue; or trouble breathing.
    --  Hepatitis B infection. If you are a carrier of the hepatitis B virus (a
        virus that affects the liver), the virus can become active while you use
        ORENCIA. Your healthcare provider may do a blood test before you start
        or while using ORENCIA.
    --  Vaccinations. You should not receive ORENCIA® (abatacept) with certain
        types of vaccines. ORENCIA may cause some vaccinations to be less
        effective.
    --  Respiratory problems in patients with COPD.You may get certain
        respiratory problems more often if you receive ORENCIA and have COPD,
        including: worsened COPD, pneumonia, cough, or trouble breathing.
    --  Cancer (malignancies). Certain kinds of cancer have been reported in
        patients receiving ORENCIA. It is not known if ORENCIA increases your
        chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

Note concerning use in children under 18 years of age: ORENCIA for SC injection has not been studied in children under 18 years of age, therefore it is not known if ORENCIA for SC injection is safe and effective in children under 18 years of age.

Please read the Patient Information in the Full US Prescribing Information.

About Clazakizumab

Clazakizumab is an investigational selective IL-6 cytokine inhibitor, under investigation for the treatment of RA. Bristol-Myers Squibb has exclusive worldwide rights to develop and commercialize clazakizumab for all indications outside of cancer under a collaboration agreement with its discoverer, Alder Biopharmaceuticals. Clazakizumab is the second biologic treatment for RA being developed by Bristol-Myers Squibb, demonstrating the company's long-standing commitment to immunoscience.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

For more information about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews

ORENCIA^(R) (abatacept) is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb Immunoscience

The immune system is the body's natural defense against disease. These processes come into play in almost every human disease. That is why Bristol-Myers Squibb is focused on exploring ways to harness the body's own immune system to treat immune-related diseases with high unmet medical needs, including RA - a chronic, systemic, inflammatory autoimmune disorder that affects the joints.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

    CONTACT: Bristol-Myers Squibb
             Media:
             Chris Clark, 609-252-6269
             chris.clark@bms.com
             or
             Investors:
             Ranya Dajani, 609-252-5330
             ranya.dajani@bms.com
             or
             Ryan Asay, 609-252-5020
             ryan.asay@bms.com

    Source: Bristol-Myers Squibb Company