SPRYCEL(R) (dasatinib) Receives CHMP Positive Opinion for the Treatment of Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia in Chronic Phase

DASISION Study Met its Primary Endpoint: 77 vs. 66 Percent of Patients Randomised to Dasatinib or Imatinib Arm Respectively Achieved a Confirmed Complete Cytogenetic Response within 12 Months (p=0.007)

PARIS, October 22, 2010 - Bristol-Myers Squibb today announced that SPRYCEL(r) (dasatinib) received
a positive opinion from the Committee for Medicinal Products for Human Use
(CHMP) for the treatment of adult patients with newly diagnosed Philadelphia
chromosome positive Chronic Myelogenous Leukaemia in Chronic Phase (CML-CP).
This decision follows the presentation of results from the pivotal DASISION
study in which dasatinib 100 mg once daily demonstrated a superior rate of
confirmed complete cytogenetic response (CCyR)[*] compared to imatinib by 12
months in chronic phase CML patients. The data was presented as a
late-breaking abstract at the 46th Annual Meeting of the American Society of
Clinical Oncology, during the Best Abstracts section of the Presidential
Symposium at the 15th Congress of the EHA and published in New England
Journal of Medicine in June 2010.

The European Medicines Agency's (EMA) CHMP adopted the positive opinion
based on the 12 month results from the DASISION trial. The European
Commission generally grants the Marketing Authorization within three months
of a positive CHMP opinion.

Commenting on the developments BMS spokesperson Renzo Canetta,
Vice-President, Oncology Global Clinical Research, said: "Bristol-Myers
Squibb is committed to working together with regulatory authorities in
different countries around the world to help ensure that CML patients and
their physicians are provided with treatment options that can achieve optimal
outcomes for their patients whether they are newly diagnosed or resistant or
intolerant to previous treatment."

DASISION Study Results

In the ongoing DASISION (Dasatinib versus Imatinib Study in
Treatment-Naïve CP-CML Patients) study, results of which were published in
the NEJM in June 2010,[1] 77% of patients in the dasatinib arm vs. 66% of
patients in the imatinib arm achieved confirmed CCyR (two consecutive
assessments of CCyR) within 12 months (p=0.007). Additionally, 83% of
dasatinib patients vs. 72% of imatinib patients achieved CCyR by one year
(p=0.001). The time to CCyR was shorter for dasatinib patients than imatinib
patients (hazard ratio = 1.5, p<0.0001), with more than half of dasatinib
patients (54%) achieving CCyR within three months. Dasatinib patients were
also twice as likely as imatinib patients to achieve a major molecular
response[**] (MMR), a more sensitive method of assessment of treatment
response,[2,3] during the course of the study (hazard ratio = 2.0, p<0.0001).

Commonly reported adverse events[1] (of all grades) with dasatinib and
imatinib respectively included superficial oedema (9% and 36%), pleural
effusions (10% and 0%), nausea (8% and 20%), rash (11% and 17%) and muscle
inflammation (4% and 17%).

About SPRYCEL (dasatinib)

Dasatinib, an oral BCR-ABL inhibitor, is currently
approved by the European Commission for the treatment of adults for all
phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with
resistance or intolerance to prior therapy including imatinib. SPRYCEL is
also approved for the treatment of adults with Philadelphia
chromosome-positive acute lymphoblastic leukemia with resistance or
intolerance to prior therapy.

The active ingredient of SPRYCEL is dasatinib. At nanomolar
concentrations, dasatinib reduces the activity of one or more proteins
responsible for the uncontrolled growth of the leukemia cells of patients
with CML or Ph+ ALL.

About Chronic Myelogenous (or Myeloid) Leukemia (CML)

CML is a slow-growing type of leukemia in which the body produces an
uncontrolled number of abnormal white blood cells. CML is most commonly
diagnosed in those aged 60-65 and the incidence is estimated at 1-2 cases per
100,000.[4] CML occurs when pieces of two different chromosomes break off and
attach to each other. The new chromosome is called the Philadelphia-positive
chromosome, which contains an abnormal gene called BCR-ABL that signals cells
to make too many white blood cells. There is no known cause for the genetic
change that causes CML.

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 against serious diseases. Around the world, our medicines are helping
millions of patients in their fight against such diseases as cancer, heart
disease, HIV/AIDS, psychiatric disorders, rheumatoid arthritis, chronic
hepatitis B virus infection and diabetes.

    References

    1. Kantarjian H, et al. N Engl J Med. 2010 Jun 17;362(24):2260-70.

    2. Branford S. Hematology. 2007:376-83.

    3. Hughes T, et al. Blood. 2006;108:28-37

    4. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167

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[*] Complete cytogenetic response (CCyR) is defined as the absence of
Philadelphia chromosome-positive metaphases on cytogenetic assessment of bone
marrow cells.

[**] Major molecular response (MMR) is defined as a BCR-ABL transcript
level of [less than or equal to]0.1% (3 log reduction) as measured by
real-time quantitative polymerase chain reaction (RQ-PCR) of peripheral
blood.

    Contacts:
    Bristol-Myers Squibb,
    European Media Contact:
    Elzbieta Zawislak, +33615523580, elzbieta.zawislak@bms.com .

Contacts: Bristol-Myers Squibb, European Media Contact: Elzbieta Zawislak, +33615523580, elzbieta.zawislak at bms.com .