Bristol-Myers Squibb GmbH & Co.KG aA

Subcutaneous Formulation of ORENCIA® (abatacept) Approved by European Commission

Paris (ots/PRNewswire) - Proven biologic is first therapy available in both subcutaneous and intravenous formulations for adults with moderate to severe active rheumatoid arthritis

Bristol-Myers Squibb announced today that the European Commission has granted marketing authorisation for the subcutaneous formulation of ORENCIA(R) (abatacept), in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active rheumatoid arthritis (RA).

To view the Multimedia News Release, please click:

http://www.epresspack.net/mnr/subcutaneous-formulation-of-orencia -abatacept-approved-by-european-commission

Most of the currently available biologics for the treatment of RA are anti-TNF (anti-tumour necrosis factor) agents. ORENCIA works through a different mechanism of action (T-cell co-stimulation modulation) and is the only agent available in both self-injectable, subcutaneous (SC) and intravenous (IV) formulations. Given that some patients prefer one route of administration for specific reasons, the availability of both formulations addresses the needs and preferences of patients and physicians.[1]

"ORENCIA is a true alternative to anti-TNFs - a first-line biologic therapy for RA patients that now also offers the convenience of self-administration in a subcutaneous formulation," said Prof. Dr. Rieke Alten, Chief Physician, Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology Schlosspark Clinic, Berlin. "ORENCIA provides a choice when deciding how to treat adults with moderate to severe active RA by offering a proven mechanism of action that is different from anti-TNFs."

The European approval of the subcutaneous formulation of ORENCIA is based on the ACQUIRE study, a pivotal phase III registrational trial, as well as long-term efficacy and safety data from supporting phase II studies. In ACQUIRE, the single largest phase III registrational trial of biologics in RA patients, the subcutaneous and intravenous formulations of ORENCIA were compared and shown to be similar in terms of efficacy and safety (non-inferiority comparison).

The intravenous formulation of ORENCIA was first approved in the European Union in May 2007 and is a well-established treatment option for adult RA patients who have an inadequate response to methotrexate alone or who have failed a first biologic DMARD.

ORENCIA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe active RA in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs), including MTX or a tumour necrosis factor (TNF)-alpha inhibitor.[2]

"Many physicians use intravenous ORENCIA for RA because it has a unique mechanism of action and a proven efficacy and safety profile", said Ron Cooper, President, Bristol-Myers Squibb, Europe. "We are pleased to be able to offer physicians and patients an efficacious and convenient self-administered formulation."

Notes to editors

Clinical Trials

ACQUIRE (Abatacept Comparison of Sub[QU]cutaneous versus Intravenous in inadequate Responders to methotrexate)[3]

In ACQUIRE, the goal was to demonstrate non-inferiority of the efficacy and comparability of the safety of subcutaneous ORENCIA relative to intravenous administration in subjects with moderate to severe active RA and experiencing inadequate response to MTX.

The trial, which was a randomised, multinational phase III study of 1,457 patients, showed that ORENCIA achieved comparable rates of efficacy for the American College of Rheumatology criteria of 20 percent (ACR20) response at month 6 in both groups of patients receiving SC injections plus methotrexate (MTX) or IV infusions plus MTX (76.1 % vs 75.7, respectively).

ACR 50 and 70 responses were comparable between ORENCIA SC and IV as were improvements in all patient-reported outcomes studied - pain, physical function and global assessment of disease activity for ORENCIA SC and IV at month 6.

At month 6, 94% of patients receiving SC injections plus MTX and 94% of patients receiving ORENCIA IV plus MTX remained in the study. The rate of injection site reactions (mostly mild) was similar across both patient groups, occurring in 19 (2.6%) patients receiving subcutaneous ORENCIA and 18 (2.5%) patients receiving intravenous ORENCIA.

This study demonstrated similar safety for patients treated with subcutaneous ORENCIA and intravenous ORENCIA. These results are consistent with the safety profile of ORENCIA.[2]

AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate)[4],[5]

In addition to and separate from the pivotal trials, the safety and efficacy of SC ORENCIA has been shown in the AMPLE study, the first direct comparison of two biologics on a background of MTX.

Presented for the first time at the EULAR 2012 congress, AMPLE is a 2-year, head-to-head trial of 646 patients comparing the subcutaneous (SC) formulation of ORENCIA with adalimumab (HUMIRA(R)) - an anti-TNF - in a standard of care setting, namely on a background of methotrexate (MTX) for biologic naïve patients with moderate to severe RA.

AMPLE demonstrated that SC ORENCIA plus MTX achieved comparable rates of efficacy for the American College of Rheumatology criteria of 20 percent (ACR20) response at 1 year of 64.8% vs. 63.4% HUMIRA plus MTX, with similar kinetics of response and inhibition of radiographic progression at one year.

There were significantly fewer injection site reactions observed with ORENCIA. The overall safety profiles of the two compounds were similar.

About ORENCIA(R) (abatacept)

ORENCIA is a selective co-stimulation modulator of T-cell activation. It is designed to prevent full T-cell activation and inhibit the release of chemicals leading to joint inflammation and destruction as observed in rheumatoid arthritis (RA).[6],[7],[8],[9].

ORENCIA is the first biologic discovered and developed by Bristol-Myers Squibb and ORENCIA IV was first approved for adult RA in May 2007 by the European Commission.

ORENCIA, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe active RA in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a tumor necrosis factor (TNF) inhibitor. A reduction in the progression of joint damage and improvement of physical function has been demonstrated during combination treatment with ORENCIA and MTX.

The new self-injectable formulation can be administered weekly through an injection under the skin following a single IV loading dose. Patients who are unable to receive an infusion may initiate weekly injections of subcutaneous ORENCIA without an intravenous loading dose.

The most frequently reported adverse reactions (greater than or equal to 5%) among ORENCIA-treated patients are headache, nausea, and upper respiratory tract infections. In younger patients, side effects are similar to adults. For the full list of all side effects reported with ORENCIA, see the Product Information.

ORENCIA should not be prescribed to persons who are hypersensitive to abatacept or any of the other ingredients. It must not be used in patients with severe and uncontrolled infections, such as sepsis or opportunistic infections. Patients who receive ORENCIA are given a special alert card that explains this restriction and instructs them to contact their doctor immediately if they develop an infection during a course of treatment.[10]

The intravenous formulation of ORENCIA, in combination with MTX, is also indicated for the treatment of moderate to severe active polyarticular Juvenile Idiopathic Arthritis (pJIA) in paediatric patients six years of age and older who have had an insufficient response to other DMARDs, including at least one TNF inhibitor. ORENCIA has not been studied in children under six years old.

For a full description of ORENCIA, including efficacy and safety profile, please consult the Summary of Product Characteristics (SmPC):

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human /medicines/000701/human_med_000958.jsp&mid=WC0b01ac058001d124

.

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.

In Europe, more than 2.9 million people are affected by RA,[11] a condition which can severely impact patients' quality of life and can lead to increased mortality and morbidity.[12] The condition is more common in women, who account for 75% of patients diagnosed with RA.[13]

With appropriate treatment, patients can achieve better clinical outcomes, resulting in more active days and improved well-being.[14]

ORENCIA is one of the biologic treatment options indicated in adult patients with moderate to severely active RA for patients who respond inadequately to previous DMARDs. The approval of the new subcutaneous formulation will offer one more option, giving some patients the opportunity to treat themselves at home.

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.

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

References

1. Scarpato S, et al. "Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study)" Rheumatology (2010) 49 (2): 289-294. doi: 10.1093/rheumatology/kep354. First published online: November 17, 2009

2. Orencia SmPC.

3. Genovese MC et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb non-inferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum 2011;63:2854-64. doi: 10.1002/art.30463

4. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Abstract 3409)

5. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Oral presentation)

6. Kremer M, et al. N Engl J Med 2003;349(20):1907-15.

7. Davis P, et al. Abstract submitted to ACR/ARHP Meeting 2008, San Francisco Oct 24-29th 2008;08-A-2321-ACR.

8. European Medicines Agency (EMEA). ORENCIA Scientific Discussion. 2007:1-36.

9. Buch MH, et al. Ann Rheum Dis 2009;68(7):1220-7.

10. European Medicines Agency website. Available at: http://www.e ma.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/00070 1/human_med_000958.jsp&mid=WC0b01ac058001d124 Last Accessed 5 September 2012.

11. National Rheumatoid Arthritis Foundation Available at: http:/ /www.nras.org.uk/about_rheumatoid_arthritis/living_with_rheumatoid_ar thritis/employment_benefits/european_fit_for_work_report.aspx Last accessed 5 September 2012.

12. March L and Lapsley H. "What are the costs to society and the potential benefits from the effective management of early rheumatoid arthritis?" Best Practice & Research Clinical Rheumatology 2001;15(1):171-185.

13. National Institute of Arthritis and Musculoskeletal and Skin Diseases. National Institutes of Health. U.S.Department of Health and Human Services. Rheumatoid Arthritis. May 2004.

14. American College of Rheumatology. Available at: http://www.rh eumatology.org/practice/clinical/patients/diseases_and_conditions/ra. asp. Last accessed 5 September 2012.

Media: Celine Van Doosselaere, celine.vandoosselaere@bms.com, +33-1-58-83-60-27

Investors: John Elicker, john.elicker@bms.com, +1(609)252-4611



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