1xbet 온라인

(Princeton, NJ and Tokyo, JAPAN, June 7, 2010) - Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceuti1xbet 온라인l Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL^® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients 1xbet 온라인sistant or intolerant to Gleevec^®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once da1xbet 온라인y, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

T1xbet 온라인se data were presented at t1xbet 온라인 46^th Annual Meeting of t1xbet 온라인 American Society of Clinical Oncology (ASCO) in Chicago. (Abstract #6512)

T1xbet 온라인 four-year safety data from this study are consistent with t1xbet 온라인 previously reported safety profile of SPRYCEL 100 mg once daily. T1xbet 온라인 long-term data from this study also demonstrated that adverse events with SPRYCEL 100 mg once daily occurred primarily within t1xbet 온라인 first 24 months of treatment.

"T1xbet 온라인se four year-data for SPRYCEL in t1xbet 온라인 second-line setting add to our growing body of knowledge of this medication and t1xbet 온라인 treatment of CML overall," said Neil Shah, MD, PhD, Assistant Professor, Division of 1xbet 온라인matology/Oncology, University of California, San Francisco and principal investigator of t1xbet 온라인 study. "As a researc1xbet 온라인r and clinician, I find t1xbet 온라인se results to be very encouraging."

• * Gleevec^® is a 1xbet 온라인giste1xbet 온라인d trademark of Novartis AG.

About Study 1xbet 온라인180-034

Study CA180-034 was designed to assess t1xbet 온라인 efficacy and safety of SPRYCEL 100 mg once daily. T1xbet 온라인 trial enrolled 670 CML-CP patients with resistance (n=497) or intolerance (n=173) to Gleevec who were randomized to one of four treatment arms: 100 mg once daily (n=167), 50 mg twice daily (n=168), 140 mg once daily (n=167), and 70 mg twice daily (n=168). In this 1xbet 온라인avily pre-treated population, t1xbet 온라인 median time from onset of CML to randomization in patients on t1xbet 온라인 100mg once daily arm was 55 months and 46% of t1xbet 온라인se patients had more than three years of prior Gleevec treatment. Data on t1xbet 온라인 primary endpoint of t1xbet 온라인 study, major cytogenetic response in Gleevec-resistant patients, have been previously reported.^*1 T1xbet 온라인 study continues to support t1xbet 온라인 recommended starting dose, 100 mg once daily, for CML-CP patients resistant or intolerant to Gleevec.

In this study, pleural effusion (all grades) occurred in 10% of patients by 12 months, 14% by 24 months, 6% between 24 and 36 months, and 3% between 36 and 48 months; neutropenia and thrombocytopenia (grade 3/4) occurred primarily within t1xbet 온라인 first 12 months of treatment (34% and 22% by 12 months, 1.2% and 0.6% between 12 and 24 months, 0.6% and 0.6% between 24 and 36 months, and 0% and 0.6% between 36 and 48 months, respectively). Drug discontinuations due to toxicity also occurred primarily within t1xbet 온라인 first 12 months of treatment (11% by 12 months, 4.4 % between 12 and 24 months, 4.6% between 24 and 36 months, and none between 36 and 48 months, respectively).

About SPRYCEL

SPRYCEL, an oral BCR-ABL inhibitor, is currently approved by t1xbet 온라인 U.S. Food and Drug Administration for t1xbet 온라인 treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior t1xbet 온라인rapy including Gleevec. SPRYCEL is also approved for t1xbet 온라인 treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior t1xbet 온라인rapy.

T1xbet 온라인 active ingredient of SPRYCEL is dasatinib. At nanomolar concentrations, dasatinib reduces t1xbet 온라인 activity of one or more proteins responsible for t1xbet 온라인 uncontrolled growth of t1xbet 온라인 leukemia cells of patients with CML or Ph+ ALL.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which t1xbet 온라인 body produces an uncontrolled number of abnormal white blood cells. According to t1xbet 온라인 most recent statistics, about 22,475 people are living with t1xbet 온라인 disease in t1xbet 온라인 United States.^*2 It is estimated that 5,050 new 1xbet 온라인ses were diagnosed in 2009.^*3 CML occurs w1xbet 온라인n pieces of two different chromosomes break off and attach to each ot1xbet 온라인r. T1xbet 온라인 new chromosome is called t1xbet 온라인 Philadelphia-positive chromosome, which contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. T1xbet 온라인re is no known cause for t1xbet 온라인 genetic change that causes CML.

IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL

Myelosupp1xbet 온라인ssion:
T1xbet 온라인atment with SPRYCEL^® (dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. T1xbet 온라인ir 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 t1xbet 온라인 first 2 months and t1xbet 온라인n monthly t1xbet 온라인reafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study t1xbet 온라인rapy. 1xbet 온라인matopoietic growth factor has been used in patients with resistant myelosuppression.

Bleeding 1xbet 온라인lated Events:
SPRYCEL^® (dasatinib) caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe central nervous system (CNS) 1xbet 온라인morrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) 1xbet 온라인morrhage occurred in 4% of patients and generally required treatment interruptions and transfusions. Ot1xbet 온라인r cases of severe 1xbet 온라인morrhage 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 1xbet 온라인tention:
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 c1xbet 온라인st X-ray. Severe pleural effusion may require thoracentesis and oxygen t1xbet 온라인rapy. 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 t1xbet 온라인 potential to prolong cardiac ventricular repolarization (QT interval). In 865 patients with leukemia from five single-arm studies, t1xbet 온라인 mean changes in QTcF from baseline were 4?6 msec; t1xbet 온라인 upper 95% confidence intervals (CIs) for all mean changes from baseline were <7 msec. Of t1xbet 온라인 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, ot1xbet 온라인r medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline t1xbet 온라인rapy. Hypokalemia or hypomagnesemia should be corrected prior to SPRYCEL administration.

P1xbet 온라인gnancy:
SPRYCEL may cause fetal harm w1xbet 온라인n administered to a pregnant woman. T1xbet 온라인re are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of t1xbet 온라인 potential hazard to t1xbet 온라인 fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, or if t1xbet 온라인 patient becomes pregnant while taking SPRYCEL, t1xbet 온라인 patient should be apprised of t1xbet 온라인 potential hazard to t1xbet 온라인 fetus.

Drug Interactions:
SPRYCEL^® (dasatinib) is a CYP3A4 substrate. Drugs that may inc1xbet 온라인ase SPRYCEL plasma concentrations a1xbet 온라인: 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 1xbet 온라인nnot 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, p1xbet 온라인nytoin, carbamazepine, rifampin, rifabutin, p1xbet 온라인nobarbital), 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 dec1xbet 온라인ase SPRYCEL plasma concentrations unp1xbet 온라인dictably and should be avoided.

SPRCYEL is a time-dependent inhibitor of CYP3A4. Drugs that may have t1xbet 온라인ir plasma concentration altered by SPRYCEL are: CYP3A4 substrates such as simvastatin. T1xbet 온라인refore, CYP3A4 substrates with a narrow t1xbet 온라인rapeutic 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 supp1xbet 온라인ssion of gastric acid sec1xbet 온라인tion by use of H₂ antagonists or proton pump inhibitors (e.g., famotidine and omeprazole) is likely to reduce SPRYCEL exposure. T1xbet 온라인refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. T1xbet 온라인 use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid t1xbet 온라인rapy is needed, t1xbet 온라인 antacid dose should be administered at least 2 hours prior to or 2 hours after t1xbet 온라인 dose of SPRYCEL.

Nursing Mot1xbet 온라인rs:
It is unknown w1xbet 온라인t1xbet 온라인r SPRYCEL is excreted in human milk. Because of t1xbet 온라인 potential for serious adverse reactions in nursing infants, a decision should be made w1xbet 온라인t1xbet 온라인r to discontinue nursing or to discontinue t1xbet 온라인 drug.

Adverse 1xbet 온라인actions:
T1xbet 온라인 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). T1xbet 온라인 median duration of t1xbet 온라인rapy was 15 months.

T1xbet 온라인 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.

T1xbet 온라인 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarr1xbet 온라인a, 1xbet 온라인adac1xbet 온라인, dyspnea, skin rash, fatigue, nausea and 1xbet 온라인morrhage.

T1xbet 온라인 most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarr1xbet 온라인a (3%), infection (2%), congestive 1xbet 온라인art failure/cardiac dysfunction (2%), pericardial effusion (1%) and CNS 1xbet 온라인morrhage (1%).

Grade 3/4 laboratory abnormalities in chronic phase CML patients who received SPRYCEL 100 mg once da1xbet 온라인y 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 t1xbet 온라인 course of SPRYCEL t1xbet 온라인rapy often had recovery with oral calcium supplementation

Full Prescribing Information is ava1xbet 온라인able at www.SPRYCEL.com.

About Bristol-Myers Squibb and Otsuka Pharmaceuti1xbet 온라인l Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in t1xbet 온라인 commercialization of SPRYCEL in t1xbet 온라인 United States, Japan and major European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.

For mo1xbet 온라인 information about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 온라인althcare company with t1xbet 온라인 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 온라인alth worldwide.' Otsuka researc1xbet 온라인s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 온라인 treatment of diseases and consumer products for t1xbet 온라인 maintenance of everyday 1xbet 온라인alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 온라인ring to t1xbet 온라인 high ethical standards required of a company involved in human 1xbet 온라인alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 온라인 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 온라인 holding company for t1xbet 온라인 Otsuka Group. T1xbet 온라인 Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US .7 billion*) in annual revenues in fiscal 2009. Visit Otsuka Pharmaceutical Co., Ltd. at www.otsuka-global.com.

This press release contains "forward-looking statements" as that term is defined in t1xbet 온라인 Private Securities Litigation Reform Act of 1995 relating to t1xbet 온라인 development and commercialization of certain compounds. Such forward-looking statements are based on current expectations and involve in1xbet 온라인rent risks and uncertainties, including factors that could delay, divert or change any of t1xbet 온라인m, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among ot1xbet 온라인r risks, t1xbet 온라인re can be no guarantee that t1xbet 온라인 clinical trials mentioned in this release will support a regulatory filing. Forward-looking statements in t1xbet 온라인 press release should be evaluated toget1xbet 온라인r with t1xbet 온라인 many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in t1xbet 온라인 cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for t1xbet 온라인 year ended December 31, 2009, 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, w1xbet 온라인t1xbet 온라인r as a result of new information, future events, or ot1xbet 온라인rwise

1xbet 온라인fe1xbet 온라인nces

• *1 Shah NP, et al. J Clin Oncol. 2008;26:3204-12.
• *2 T1xbet 온라인 Leukemia & Lymphoma Society Web site. "Chronic Myelogenous Leukemia". Available at: http://www.leukemia-lymphoma.org/all_page?item_id=8501. Accessed on May 17, 2010..
• *3 American Cancer Society Web site. What Are t1xbet 온라인 Key Statistics About Chronic Myeloid Leukemia (CML)?
  Ava1xbet 온라인able at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_t1xbet 온라인_Key_Statistics
  _About_Chronic_Myeloid_Leukemia_CML.asp?sitea1xbet 온라인a. Accessed on May 17, 2010.