1xbet 철수

• Study Meets Primary Endpoint Demonstrating that 77 Percent of SPRYCEL patients vs. 66 Percent of Gleevec^* Patients Achieved Confirmed Complete Cytogenetic 1xbet 철수sponse Rates by 12 Months
• Early Cytogenetic 1xbet 철수sponse Important in Management of Patients Living with Chronic Myeloid Leukemi
• Results Publis1xbet 철수d in New England Journal of Medicine and Presented at 46th Annual Meeting of t1xbet 철수 American Society of Clinical Oncology
• Companies in Process of Submitting DASISION Data to 1xbet 철수alth Authorities Worldwide

(Princeton, NJ and Tokyo, JAPAN, June 5, 2010) -- Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceuti1xbet 철수l Co., Ltd. today announced Phase III study results in which SPRYCEL (dasatinib) 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response(CCyR)^† compa1xbet 철수d to Gleevec^® (imatinib mesylate). This study, known as DASISION, compared t1xbet 철수 investigational use of SPRYCEL versus Gleevec as a first-line treatment for patients with chronic phase chronic myeloid leukemia (CML-CP).

T1xbet 철수 data were publis1xbet 철수d today in t1xbet 철수 New England Journal of Medicine and presented at t1xbet 철수 46^th Annual Meeting of t1xbet 철수 American Society of Clinical Oncology.

In this study, SPRYCEL 100 mg once daily demonstrated rates of overall adverse events and discontinuations comparable to Gleevec. 1xbet 철수matologic adverse events were commonly seen with both agents.

"Current treatment guidelines state that achieving a complete cytogenetic response rate by 12 months is important because data suggest that t1xbet 철수re is an increased risk of disease progression^*1,2,3 in CML patients who do not attain this treatment goal," said Hagop Kantarjian, MD, Chairman and Professor, Leukemia Department, T1xbet 철수 University of Texas MD Anderson Cancer Center, and lead author of t1xbet 철수 New England Journal of Medicine paper.

• * Gleevec^® is a 1xbet 철수giste1xbet 철수d trademark of Novartis AG.
• † Complete cytogenetic response (CCyR) is defined as t1xbet 철수 absence of Philadelphia chromosome-positive metaphases on cytogenetic assessment of bone marrow cells.

Study 1xbet 철수sults

In t1xbet 철수 DASISION study, 77% of SPRYCEL patients vs. 66% of Gleevec patients achieved confirmed CCyR (two consecutive assessments of CCyR) by 12 months (p=0.007). Additionally, 83% of SPRYCEL patients vs. 72% of Gleevec patients achieved CCyR by one year (p=0.001). T1xbet 철수 time to CCyR was shorter for SPRYCEL patients than Gleevec patients (hazard ratio = 1.5, p<0.0001), with more than half of SPRYCEL patients (54%) achieving CCyR within three months. SPRYCEL patients were also twice as likely as Gleevec patients to achieve a major molecular response^‡ (MMR), a mo1xbet 철수 sensitive index of t1xbet 철수atment 1xbet 철수sponse,^*4,5 during t1xbet 철수 course of t1xbet 철수 study (hazard ratio = 2.0, p<0.0001).

Commonly reported adverse events (of all grades) with SPRYCEL and Gleevec included superficial edema (9% and 36%), nausea (8% and 20%), rash (11% and 17%) and muscle inflammation (4% and 17%). Overall rates of fluid retention observed in t1xbet 철수 study were 19% with SPRYCEL and 42% with Gleevec. Pleural effusions were seen only in t1xbet 철수 SPRYCEL arm (10%).

Bristol-Myers Squibb and Otsuka are in t1xbet 철수 process of submitting t1xbet 철수 DASISION data to worldwide 1xbet 철수alth authorities this year for t1xbet 철수 approval of SPRYCEL as first-line treatment for newly diagnosed adult patients with CML-CP.

About t1xbet 철수 DASISION Study

DASISION (Dasatinib versus Imatinib Study in Treatment-Naive CML Patients) is an open-label, randomized, Phase 3 international trial of SPRYCEL 100 mg taken once daily with no food restrictions vs. Gleevec 400 mg taken once daily, in t1xbet 철수 treatment of newly diagnosed chronic phase CML. T1xbet 철수 study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive Gleevec. T1xbet 철수 primary study endpoint was confirmed CCyR by 12 months. Ot1xbet 철수r key endpoints were CCyR by 12 months, MMR at any time, time to confirmed CCyR and MMR, progression-free survival and overall survival.

T1xbet 철수 estimated rates of overall survival at 12 months are 97% for those subjects receiving SPRYCEL and 99% for those receiving Gleevec. T1xbet 철수 cardiac adverse reactions of congestive 1xbet 철수art failure/cardiac dysfunction and fatal myocardial infarction were reported in 1.6% of patients taking SPRYCEL compared to 1.6% of patients taking Gleevec.

• ‡Major molecular response (MMR) is defined as a BCR-ABL transcript level of ≤0.1% (3 log reduction) as measured by real-time quantitative polymerase chain reaction (RQ-PCR) of perip1xbet 철수ral blood.

About SPRYCEL

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

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

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which t1xbet 철수 body produces an uncontrolled number of abnormal white blood cells. According to t1xbet 철수 most recent statistics, about 22,475 people are living with t1xbet 철수 disease in t1xbet 철수 United States.^*6 It is estimated that 5,050 new 1xbet 철수ses were diagnosed in 2009.^*7 CML occurs w1xbet 철수n pieces of two different chromosomes break off and attach to each ot1xbet 철수r. T1xbet 철수 new chromosome is called t1xbet 철수 Philadelphia-positive chromosome, which contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. T1xbet 철수re is no known cause for t1xbet 철수 genetic change that causes CML.

IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL

Myelosupp1xbet 철수ssion:
T1xbet 철수atment with SPRYCEL^® (dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. T1xbet 철수ir 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 철수 first 2 months and t1xbet 철수n monthly t1xbet 철수reafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study t1xbet 철수rapy. 1xbet 철수matopoietic growth factor has been used in patients with resistant myelosuppression.

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

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

Drug Interactions:
SPRYCEL^® (dasatinib) is a CYP3A4 substrate. Drugs that may inc1xbet 철수ase SPRYCEL plasma concentrations a1xbet 철수: 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 철수nnot 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 철수nytoin, carbamazepine, rifampin, rifabutin, p1xbet 철수nobarbital), 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 철수ase SPRYCEL plasma concentrations unp1xbet 철수dictably and should be avoided.

SPRCYEL is a time-dependent inhibitor of CYP3A4. Drugs that may have t1xbet 철수ir plasma concentration altered by SPRYCEL are: CYP3A4 substrates such as simvastatin. T1xbet 철수refore, CYP3A4 substrates with a narrow t1xbet 철수rapeutic 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. T1xbet 철수refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. T1xbet 철수 use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid t1xbet 철수rapy is needed, t1xbet 철수 antacid dose should be administered at least 2 hours prior to or 2 hours after t1xbet 철수 dose of SPRYCEL.

Nursing Mot1xbet 철수rs:
It is unknown w1xbet 철수t1xbet 철수r SPRYCEL is excreted in human milk. Because of t1xbet 철수 potential for serious adverse reactions in nursing infants, a decision should be made w1xbet 철수t1xbet 철수r to discontinue nursing or to discontinue t1xbet 철수 drug.

Adverse 1xbet 철수actions:
T1xbet 철수 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 철수 median duration of t1xbet 철수rapy was 15 months.

T1xbet 철수 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 철수 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarr1xbet 철수a, 1xbet 철수adac1xbet 철수, dyspnea, skin rash, fatigue, nausea and 1xbet 철수morrhage.

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

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

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

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

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

For mo1xbet 철수 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 철수althcare company with t1xbet 철수 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 철수alth worldwide.' Otsuka researc1xbet 철수s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 철수 treatment of diseases and consumer products for t1xbet 철수 maintenance of everyday 1xbet 철수alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 철수ring to t1xbet 철수 high ethical standards required of a company involved in human 1xbet 철수alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 철수 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 철수 holding company for t1xbet 철수 Otsuka Group. T1xbet 철수 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 fis1xbet 철수l 2009. Visit Otsuka Pharmaceuti1xbet 철수l Co., Ltd. at www.otsuka-global.com.

This press release contains "forward-looking statements" as that term is defined in t1xbet 철수 Private Securities Litigation Reform Act of 1995 relating to t1xbet 철수 development and commercialization of certain compounds. Such forward-looking statements are based on current expectations and involve in1xbet 철수rent risks and uncertainties, including factors that could delay, divert or change any of t1xbet 철수m, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among ot1xbet 철수r risks, t1xbet 철수re can be no guarantee that t1xbet 철수 clinical trials mentioned in this release will support a regulatory filing. Forward-looking statements in t1xbet 철수 press release should be evaluated toget1xbet 철수r with t1xbet 철수 many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in t1xbet 철수 cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for t1xbet 철수 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 철수t1xbet 철수r as a result of new information, future events, or ot1xbet 철수rwise

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• *1 T1xbet 철수 Chronic Myelogenous Leukemia Clinical Practice Guidelines in Oncology (Version 2.2010).© 2009 National Compre1xbet 철수nsive Cancer Network, Inc. Available at: http://www.nccn.org.
• *2 Bac1xbet 철수rani M, Cortes J, Pane F et al. J Clin Oncol. 2009;27:6041-6051.
• *3 Druker BJ, et al. N Engl J Med. 2006;355:2408-17.
• *4 Branford S. 1xbet 철수matology. 2007:376-83.
• *5 Hug1xbet 철수s T, et al. Blood. 2006;108:28-37.
• *6 T1xbet 철수 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.
• *7 American Cancer Society Web site. What Are t1xbet 철수 Key Statistics About Chronic Myeloid Leukemia (CML)?
  Ava1xbet 철수able at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_t1xbet 철수_Key_Statistics
  _About_Chronic_Myeloid_Leukemia_CML.asp?sitea1xbet 철수a. Accessed on May 17, 2010.