European Commission Grants Approval for ORENCIA(R) (abatacept) for Treatment of Rheumatoid Arthritis

RUEIL- MALMAISON, France, May 23 (ots/PRNewswire) -

- Innovative, First-in-Class Medicine Provides New Option for
Europeans With Debilitating Disease

Bristol-Myers Squibb (NYSE: BMY) announced today the European
Commission has granted an approval for ORENCIA(R) (abatacept) for the
treatment of rheumatoid arthritis (RA), a disease that may affect up
to 4.5 million people in the European Union (1),(2).

ORENCIA(R) is a novel medicine as the first and only selective
co-stimulation modulator of Tcell activation. ORENCIA(R) is the first
biologic discovered and developed in Bristol-Myers Squibb research
centers and will be available in several countries in the European
Union as of June 2007.

ORENCIA(R), in combination with methotrexate - a standard therapy
for RA patients - is indicated for the treatment of moderate to
severe active rheumatoid arthritis in adult patients who have had an
insufficient response or intolerance to other disease-modifying
anti-rheumatic drugs including at least one anti-tumour necrosis
factor (TNF) inhibitor. A reduction in the progression of joint
damage and improvement of physical function has been demonstrated
with combination treatment with ORENCIA(R) and methotrexate.

"Orencia is the third new medicine we have launched in Europe in
the past 11 months, demonstrating Bristol-Myers Squibb's commitment
to bringing innovative medicines to patients with unmet medical
needs, " said Beatrice Cazala, President, Europe, Middle East and
Africa for Bristol-Myers Squibb. "Orencia is the next generation
biologic and offers physicians a new way of treating patients with
rheumatoid arthritis."

Autoimmune diseases such as RA are characterized by an overactive
immune system that turns its attack on itself instead of invading
microbes. This immune system attack causes inflammation, pain,
stiffness and swelling of the joints and can eventually lead to
cartilage breakdown, bone loss and weakness of the joints. The costs
of inadequately controlled rheumatoid arthritis, which include lost
productivity and earnings of patients and caregivers, represent a
substantial burden, particularly in working-age patients(3).

T-cells are immune cells thought to play a major role in the
development of rheumatoid arthritis(4). Full activation of T-cells
requires two signals: a main one and a second, costimulatory signal.
ORENCIA(R) interrupts the inflammatory process associated with
rheumatoid arthritis by selectively modulating one of the necessary
costimulatory activation signals.

"Rheumatoid arthritis patients live with pain, discomfort and
disfigurement, believing there is little that can be done," said Paul
Emery, M.D., Arc Professor of Rheumatology; Clinical Director,

Leeds Teaching Hospitals Trust, Academic Unit of Musculoskeletal
Disease, Department of Rheumatology, Leeds General Infirmary, Leeds,
United Kingdom. "The response we see with Orencia can lead to more
active days for rheumatoid arthritis patients, part of our goal to
improve all clinical outcomes, including patient well-being."

The efficacy and safety profile of ORENCIA(R) have been studied
through a clinical trial program that included more than 2,600
patients across the placebo-controlled and open-label extension
periods of the clinical trials. ORENCIA(R) in combination with
methotrexate demonstrated significant and sustained improvement of
the signs and symptoms of rheumatoid arthritis patients who failed or
were inadequate responders to currently-available therapies such as
methotrexate or anti-TNF inhibitors. ORENCIA(R) in combination with
methotrexate also demonstrated significant and clinically meaningful
improvement in physical function that was maintained up to 48 months

With regards to disease-modifying effect assessed
radiographically, ORENCIA(R) in combination with methotrexate reduced
the rate of progression of structural joint damage compared to
placebo and methotrexate after 12 months and further reduction in
X-ray progression was seen through two years.

Medicinal products, including ORENCIA(R), which affect the immune
system may affect host defences against infections and malignancies.
Serious infections at least possibly related to treatment were
reported in 1.8% of patients with ORENCIA(R) and in 1.0% of patients
not treated by ORENCIA(R) (receiving placebo). There is a need to
evaluate and monitor the patients regarding the risk of infection
prior to and during treatment. In the placebo-controlled clinical
trials, the frequency of malignancies with ORENCIA(R) was 1.4% and
with placebo 1.1%. These rates are similar to that observed in the
general rheumatoid arthritis population(5)

ORENCIA(R) is contraindicated in patients with severe and
uncontrolled infections such as sepsis and opportunistic infections
and in patients with hypersensitivity to the active substance or to
any of the excipients. Allergic reactions have been reported
uncommonly with ORENCIA(R) in clinical trials, where patients were
not required to be pretreated to prevent allergic reactions. In the
case of any serious allergic/anaphylactic reaction, ORENCIA(R) should
be discontinued.

ORENCIA(R) is initially administered in a 30-minute intravenous
injection on the first, 15th and 30th day of treatment, then once
every four weeks thereafter. ORENCIA(R) is approximately dosed at 10
milligrams per each kilogram of body weight and without need for
premedication. Administration times of other currently available
intravenous treatments for rheumatoid arthritis can be two hours or
more per treatment. Treatment with ORENCIA(R) should be initiated and
supervised by specialist physicians experienced in the diagnosis and
treatment of rheumatoid arthritis.

Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
life.

ORENCIA(R) is a trademark of Bristol-Myers Squibb.

Refer to the ORENCIA(R) Summary of Product Characteristics for
further information or contact Brian Henry, Bristol-Myers Squibb
Corporate and Business Communications, on +33-1-58-83-69-38.

(1)
http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-SF-07-041/EN/
KS-SF-07-041-EN.PDF accessed 25-04-07

(2)http://ec.europa.eu/health/ph_information/dissemination/diseases/
musculo_en.htm accessed 25-04-07.

(3) Pugner KM, Scott DI, Holmes JW, et al. The costs of rheumatoid
arthritis: an international long-term view. Sem Arthritis Rheum.
2000;29:305-20.

(4) Choy EH, Panayi GS. "Cytokine Pathways and Joint Inflammation
in Rheumatoid Arthritis." N Engl J Med. 2001;344:907-916. In
health-related quality of life, clinically and statistically
significant improvement was observed in the ORENCIA group as compared
with the placebo group in all individual and composite physical and
mental health aspects.

(5) Simon T, poster presentation at EULAR 2006

RUEIL-MALMAISON, France, May 23 /PRNewswire/ --

ots Originaltext: Bristol-Myers Squibb
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Contact: Brian Henry, Bristol-Myers Squibb, Office:
+33-1-58-83-69-38, Mobile: +33-6-75-09-08-99, e-mail:
brian.henry@bms.com


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