New Data on Bristol-Myers Squibb Oncology Compounds to be Featured in Oral Presentations at 51st Annual Meeting of the American Society of Hematology

Bristol-Myers Squibb Company (NYSE: BMY) today announced that more than 80 abstracts highlighting compounds from the company’s oncology portfolio will be presented at the 51^st Annual Meeting of the American Society of Hematology (ASH) to be held December 5-8 in New Orleans.

Two oral presentations will feature data on the investigational use of SPRYCEL® (dasatinib) in patients with newly-diagnosed chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL). A third oral presentation will highlight data on elotuzumab, an investigational compound in development for patients with multiple myeloma. Elotuzumab is a humanized monoclonal antibody directed against a cell-surface glycoprotein called CS1.

"Bristol-Myers Squibb is committed to developing innovative medicines that address areas of significant unmet medical need such as CML, Ph(+) ALL and multiple myeloma,” said Renzo Canetta, M. D., vice president, Oncology Global Clinical Research, Bristol-Myers Squibb. "The data being presented at ASH from our portfolio of oncology assets underscore Bristol-Myers Squibb’s commitment to seeking advances in care for patients with hematological malignancies.”

Results from a Phase 2 trial evaluating the safety and efficacy of SPRYCEL in the treatment of newly-diagnosed CML patients, which was conducted by the University of Texas M.D. Anderson Cancer Center, will be the subject of one oral presentation. The abstract titled "Efficacy of Dasatinib in Patients with Previously Untreated CML in Early Chronic Phase” is scheduled for presentation on Monday, December 7, 2009 at 10:45 a.m.

Results from the ongoing international Phase 3 head-to-head clinical trial of SPRYCEL (100 mg once daily) vs. Gleevec^®* (imatinib; 400mg once daily) in the first-line treatment of CML are expected in the first half of 2010.

SPRYCEL data will also be featured in an oral presentation on newly-diagnosed Ph(+) ALL patients from a Phase 2 study conducted by M.D. Anderson Cancer Center. The abstract titled "Phase II Study of Combination of the HyperCVAD Regimen with Dasatinib in the Front Line Therapy of Patients with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia” will be presented on Tuesday, December 8, 2009 at 8:00 a.m..

The third oral presentation will highlight results from a Phase 1/2 study evaluating the potential of elotuzumab with lenalidomide and low dose dexamethasone in patients with relapsed or refractory multiple myeloma. The abstract titled "Phase 1/2 Study of Elotuzumab in Combination with Lenalidomide and Low Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma: Interim Results” will be presented on Monday, December 7, 2009 at 11:45 a.m. Bristol-Myers Squibb is developing elotuzumab in collaboration with Facet Biotech Corporation.

For a complete listing of SPRYCEL, elotuzumab and tanespimycin abstracts to be presented at ASH, visit www.hematology.org

About SPRYCEL

SPRYCEL, an oral tyrosine kinase inhibitor, is currently approved by the U.S. Food and Drug Administration 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 Gleevec. It is the first and only oral therapy for Gleevec-resistant or -intolerant CML patients with survival data in the Prescribing Information. SPRYCEL is also approved for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL

Myelosuppression:

Treatment with SPRYCEL^® (dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. Their occurrence is more frequent in advanced phase CML or Ph+ ALL than in chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities. Complete blood counts (CBCs) should be performed weekly for the first 2 months and then monthly thereafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression.

Bleeding Related Events:

SPRYCEL^® (dasatinib) caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe central nervous system (CNS) hemorrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hemorrhage occurred in 4% of patients and generally required treatment interruptions and transfusions. Other cases of severe hemorrhage occurred in 2% of patients. Most bleeding events were associated with severe thrombocytopenia. Caution is advised in patients required to take medications that inhibit platelet function or anticoagulants.

Fluid Retention:

Fluid retention was severe in 10% of patients, including pleural and pericardial effusions reported in 7% and 1%, respectively. Severe ascites and generalized edema were each reported in <1% of patients. Severe pulmonary edema was reported in 1% of patients. Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by chest X-ray. Severe pleural effusion may require thoracentesis and oxygen therapy. Fluid retention was typically managed by supportive care measures that included diuretics or short courses of steroids. Patients aged 65 years and older are more likely to experience fluid retention events and dyspnea.

QT Prolongation:

In vitro data suggest that SPRYCEL has the potential to prolong cardiac ventricular repolarization (QT interval). In 865 patients with leukemia from five single-arm studies, the mean changes in QTcF from baseline were 4–6 msec; the upper 95% confidence intervals (CIs) for all mean changes from baseline were <7 msec. Of the 2182 patients treated with SPRYCEL in clinical studies, 14 (<1%) patients had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF >500 msec. SPRYCEL should be administered with caution to patients who have or may develop prolongation of QTc, including patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhythmic drugs, other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy. Hypokalemia or hypomagnesemia should be corrected prior to SPRYCEL administration.

Pregnancy:

SPRYCEL may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, or if the patient becomes pregnant while taking SPRYCEL, the patient should be apprised of the potential hazard to the fetus.

Drug Interactions:

SPRYCEL^® (dasatinib) is a CYP3A4 substrate. Drugs that may increase SPRYCEL plasma concentrations are: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If systemic administration of a potent CYP3A4 inhibitor cannot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered. Grapefruit juice may also increase plasma concentrations of SPRYCEL and should be avoided. Drugs that may decrease SPRYCEL plasma concentrations are: Strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), which should be avoided. Alternative agents with less enzyme induction potential should be considered. If SPRYCEL must be administered with a CYP3A4 inducer, a dose increase in SPRYCEL should be considered. St John’s Wort may decrease SPRYCEL plasma concentrations unpredictably and should be avoided.

SPRYCEL is a time-dependent inhibitor of CYP3A4. Drugs that may have their plasma concentration altered by SPRYCEL are: CYP3A4 substrates such as simvastatin. Therefore, CYP3A4 substrates with a narrow therapeutic index (e.g., alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving SPRYCEL.

Long-term suppression of gastric acid secretion by use of H₂ antagonists or proton pump inhibitors (e.g., famotidine and omeprazole) is likely to reduce SPRYCEL exposure. Therefore, concomitant use of H₂ antagonists or proton pump inhibitors with SPRYCEL is not recommended. The use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of SPRYCEL.

Nursing Mothers:

It is unknown whether SPRYCEL is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.

Adverse Reactions:

The safety data reflect exposure to SPRYCEL^® (dasatinib) in 2182 patients with CML or Ph+ ALL in clinical studies with a minimum of 2 years follow-up (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily). The median duration of therapy was 15 months.

The majority of SPRYCEL-treated patients experienced adverse reactions at some time. Drug was discontinued for adverse reactions in 15% of patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

The most frequently reported adverse reactions (reported in =20% of patients) included myelosuppression, fluid retention events, diarrhea, headache, dyspnea, skin rash, fatigue, nausea and hemorrhage.

The most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%) and CNS hemorrhage (1%).

Grade 3/4 laboratory abnormalities in chronic phase CML patients who received SPRYCEL 100 mg once daily included neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%) and hypokalemia (2%).

Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported in patients with all phases of CML, but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML. Elevations in transaminase or bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3/4 hypocalcemia during the course of SPRYCEL therapy often had recovery with oral calcium supplementation.

Full Prescribing Information is available at www.sprycel.com.

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. For more information, please visit www.bms.com/.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 relating to the development and commercialization of certain products and potential 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. Among other risks, there can be no guarantee that the clinical trials mentioned in this release will support regulatory filings. Forward-looking statements in the 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, 2008, its Quarterly Reports on Form 10-Q, and 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.

* Gleevec® is a registered trademark of Novartis AG