Press Release

For European Journalists Only
EMBARGO: TUESDAY, 11 DECEMBER 2007, 14H00 CET

Bristol-Myers Squibb Media Fact-Sheet
The American Society of Hematology
49th Annual Meeting and Exposition
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• The latest data for SPRYCELTM (dasatinib), Bristol-Myers Squibb’s novel multi-targeted CML treatment, is presented in 56 abstracts, of which there are 12 oral presentations. Longer term SPRYCEL data was also included during the official press briefing of the 49th Annual Meeting and Exposition of the American Society of Hematology (ASH).

• Two-year results of the START (SRC/ABL Tyrosine kinase inhibition Activity Research Trial) programme continue to demonstrate long-term efficacy and tolerability of SPRYCEL in the treatment of chronic myeloid leukaemia (CML). Furthermore, the efficacy continues to increase over time.

• Key 2-year efficacy results START C and START R:

START C - Efficacy of dasatinib in patients with chronic-phase chronic myelogenous leukemia (CML-CP) with resistance or intolerance to imatinib: 2 year follow up data
 Progression free survival (PFS) of 80% and overall survival (OS) of 94%
• Patients with imatinib resistance:
o OS with SPRYCEL treatment 92%
o PFS with SPRYCEL treatment 75%
• Patients with imatinib intolerance:
o OS with SPRYCEL treatment 100%
o PFS with SPRYCEL treatment 94%
 Complete cytogenetic response (CCyR) was achieved in 53% of patients and 47% of patients achieved major molecular response (MMR)1
START R – Dasatinib or high-dose imatinib for patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant to standard-dose imatinib: 2-year follow up data  SPRYCEL is superior to imatinib 800mg for patients experiencing previous imatinib failure on 400mg-600mg
 Statistically significant improved efficacy at 2 years with SPRYCEL over imatinib 800mg
• PFS: SPRYCEL 86% vs imatinib 65%
• CCyR: SPRYCEL 44% vs imatinib 18%
• MMR: SPRYCEL 29% vs imatinib 12%2

• The START trials have demonstrated that SPRYCEL has a predictable and manageable side-effect profile at 70mg twice daily. A subsequent phase III dose-optimisation study of CML-CP using SPRYCEL 100mg once daily has similar efficacy with less frequent fluid retention and cytopenia. 100mg once daily SPRYCEL treatment is now the approved starting dose for CML-CP in Europe.

• These results add to evidence that SPRYCEL, the first significant advance in the medical treatment of CML in the five years since imatinib was approved in 2001, is addressing the previously unmet need for CML patients resistant or intolerant to prior treatment, including imatinib. Upon approval by the European Commission in November 2006, SPRYCEL became the first multi-targeted TKI approved in Europe for treatment in imatinib-resistant patients.

• Optimising patient care in CML:
 Data from three Phase II/III SPRYCEL clinical studies were evaluated in a study entitled: Importance of early intervention with dasatinib at cytogenetic rather than hematologic resistance to imatinib. The results highlight:
 The importance of close monitoring of treatment response in CML and argues for early intervention in case of imatinib resistance
 Intervention with SPRYCEL is more effective for individuals with chronic-phase CML than for those with advanced-phase disease3

• Further developments:
 Early data from an independent study of SPRYCEL in a 1st line setting: Efficacy of dasatinib in patients with previously untreated chronic myelogenous leukemia in early chronic phase CML, demonstrate impressive results 4:
 SPRYCEL induced rapid CCyR responses in most patients
 100% of patients receiving SPRYCEL treatment achieved CCyR at 12 months
 For further information on these study results please refer to the MD Anderson press release at www.mdanderson.org/departments/newsroom

Preliminary data were announced of the first phase I/II study of SPRYCEL in children and adolescents (age 1-20 years) with relapsed or refractory leukaemia supporting the safety and efficacy of SPRYCEL in paediatric patients5

 SPRYCEL was discovered and has been developed by Bristol-Myers Squibb scientists together with CML experts. SPRYCEL received European Commission approval in 2006 and is now approved in more than 50 countries worldwide including 29 European countries, the United States, Canada, India, Peru, Argentina and Australia .

- Ends -

For further information or to arrange telephone or in-person interviews please contact:

Yvette Venable, Bristol-Myers Squibb EMEA 
Office: +33 1 58 83 81 89 Mobile +33 6 31 43 76 26

Richard Marks Ogilvy Healthworld PR Office: +44 20 7108 6547, Mobile: +44 7986 623 909

References
1. Stone R et al. Efficacy of Dasatinib in Patients with Chronic-phase Chronic Myelogenous Leukemia with Resistance or Intolerance to Imatinib: 2-year Follow-up Data from START-C (CA180-013). Abstract no. 734, 11 December 2007, 49th Annual Congress and Exhibition of the American Society of Hematology, Atlanta (Georgia), USA.
2. Kantarjian H et al. Dasatinib or High-dose Imatinib for Patients with Chronic-phase Chronic Myeloid Leukemia Resistant to Standard-dose Imatinib: 2-year Follow-up Data from START-R (CA180-017). Abstract no. 736, 11 December 2007, 49th Annual Congress and Exhibition of the American Society of Hematology, Atlanta (Georgia), USA.
3. Kantarjian H et al. Importance of Early Intervention with Dasatinib at Cytogenetic Rather Than Hematologic Resistance to Imatinib. Abstract no, 1036, December 8, 2007, 49th Annual Congress and Exhibition of the American Society of Hematology, Atlanta (Georgia), USA.
4. Cortes J et al. Efficacy of Dasatinib in Patients (pts) with Previously Untreated Chronic Myelogenous Leukemia (CML) in Early Chronic Phase (CML-CP). Abstract no. 30, 9 December 2007, 49th Annual Congress and Exhibition of the American Society of Hematology, Atlanta (Georgia), USA.
5. Zwaan M et al. Dasatinib (SPRYCEL) in Children and Adolescents with Relapsed or Refractory Leukemia: Preliminary Results of the CA180018 Phase I/II Study from the ITCC Consortium. Abstract no. 1049, 8 December 2007, 49th Annual Congress and Exhibition of the American Society of Hematology, Atlanta (Georgia), USA.