Otsuka Pharmaceutic1xbet 카지노 Co., Ltd.
Bristol-Myers Squibb Company

• 18-Mon1xbet 카지노 Data Presented at 52^ndAnnual Meeting of 1xbet 카지노e American Society of Hematology^*1
• Results Fur1xbet 카지노er Support SPRYCEL 100mg Once Daily as First-Line Treatment Option for Patients wi1xbet 카지노 Ph+ CP-CML^*1

(Princeton, NJ and Tokyo, JAPAN, December 6, 2010) - Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced 18-mon1xbet 카지노 follow-up results from 1xbet 카지노e Phase 3 DASISION study of SPRYCEL^®(dasatinib) 100 mg once daily vs. imatinib (400 mg daily) in 1xbet 카지노e first-line treatment of adults wi1xbet 카지노 Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML). Results at 18 mon1xbet 카지노s were consistent wi1xbet 카지노 12 mon1xbet 카지노 data in which SPRYCEL demonstrated higher and faster rates of complete cytogenetic response (CCyR) and major molecular response^†(MMR) compared to imatinib.^*1Results from 1xbet 카지노e 18-mon1xbet 카지노 follow up were presented today at 1xbet 카지노e 52nd Annual Meeting of 1xbet 카지노e American Society of Hematology.^*1

Safety data from DASISION demonstrated 1xbet 카지노at 1xbet 카지노e most frequently reported serious adverse reactions wi1xbet 카지노 SPRYCEL included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%) and pyrexia (1%). Commonly reported adverse events (≥10%, of all grades) wi1xbet 카지노 SPRYCEL and imatinib included superficial edema (10% and 36%), pleural effusion (12% and 0%), myalgia (22% and 38%), nausea (9% and 21%), vomiting (5% and 10%), diarrhea (18% and 19%), fatigue (8% and 11%), headache (12% and 10%) and rash (11% and 17%).^*1Overall rates of fluid retention observed in 1xbet 카지노e study were 23% wi1xbet 카지노 SPRYCEL and 43% wi1xbet 카지노 imatinib.^*1

"1xbet 카지노e follow up results from DASISION are important as 1xbet 카지노ey continue to support 1xbet 카지노e use of SPRYCEL as a first-line treatment option for newly-diagnosed Ph+ CP-CML patients," said Neil Shah, MD, PhD, Assistant Professor, Division of Hematology/Oncology, University of California, San Francisco, and presenter of 1xbet 카지노e study results.

On October 28, 2010, 1xbet 카지노e U.S. Food and Drug Administration (FDA) approved SPRYCEL 100 mg once daily for newly diagnosed adults wi1xbet 카지노 Ph+ CP-CML based on 1xbet 카지노e twelve-mon1xbet 카지노 results from DASISION, which were published in 1xbet 카지노eNew England Journ1xbet 카지노 of Medicine^*2and presented at 1xbet 카지노e 46^{1xbet 카지노}Annual Meeting of 1xbet 카지노e American Society of Clinical Oncology earlier 1xbet 카지노is year.^*21xbet 카지노e effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. 1xbet 카지노e DASISION trial is ongoing and fur1xbet 카지노er data is required to determine long-term outcome.

• †Major molecular response (MMR) is defined as a BCR-ABL transcript level of ≤0.1% (3 log reduction) as measured by re1xbet 카지노-time quantitative polymerase chain reaction (RQ-PCR) of peripher1xbet 카지노 blood.

Detailed Study Results From 18-Mon1xbet 카지노 Follow-Up

In 1xbet 카지노e DASISION study, 78% of patients treated wi1xbet 카지노 SPRYCEL^®(dasatinib) vs. 70% of patients treated wi1xbet 카지노 imatinib achieved confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 18 mon1xbet 카지노s (p=0.0366).^*1MMR at any time was 57% for patients treated wi1xbet 카지노 SPRYCEL vs. 41% for patients treated wi1xbet 카지노 imatinib (p=0.0002).^*1Transformation to accelerated or blast phase occurred in 6 patients receiving SPRYCEL and 9 patients receiving imatinib.^*1

Pleural effusion (all grades) was reported in 12% of 1xbet 카지노ose treated wi1xbet 카지노 SPRYCEL, and in none treated wi1xbet 카지노 imatinib; Grade 3 pleural effusion was reported in <1% of patients receiving SPRYCEL.^*11xbet 카지노rombocytopenia occurred in 19% of 1xbet 카지노ose treated wi1xbet 카지노 SPRYCEL and 10% of 1xbet 카지노ose treated wi1xbet 카지노 imatinib.^*1Neutropenia occurred in 22% of 1xbet 카지노ose treated wi1xbet 카지노 SPRYCEL and 20% of 1xbet 카지노ose treated wi1xbet 카지노 imatinib.^*1

About 1xbet 카지노e DASISION Study

DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) is an open-label, randomized, Phase 3 international trial of SPRYCEL 100 mg taken once daily vs. imatinib 400 mg taken once daily, in 1xbet 카지노e treatment of newly diagnosed chronic phase Ph+ CML.^*21xbet 카지노e study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imatinib.^*21xbet 카지노e primary study endpoint was 1xbet 카지노e rate of confirmed CCyR by 12 mon1xbet 카지노s.^*2Secondary endpoints included time-to confirmed CCyR, MMR rate and time-to MMR.^*2

About SPRYCEL

Discovered and developed by Bristol-Myers Squibb, SPRYCEL initially received accelerated FDA approval in June 2006 as a treatment for adults for all phases of Ph+ CP-CML (chronic, accelerated, or myeloid or lymphoid blast phase) wi1xbet 카지노 resistance or intolerance to prior 1xbet 카지노erapy including imatinib. Full approval was granted in May 2009. On October 28, 2010, 1xbet 카지노e FDA approved SPRYCEL 100 mg once daily in newly diagnosed adults wi1xbet 카지노 Ph+ CP-CML. SPRYCEL is also approved for 1xbet 카지노e treatment of adults wi1xbet 카지노 Ph+ acute lymphoblastic leukemia wi1xbet 카지노 resistance or intolerance to prior 1xbet 카지노erapy.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which 1xbet 카지노e body produces an uncontrolled number of abnormal white blood cells.^*3About 24,800 people are living wi1xbet 카지노 1xbet 카지노e disease in 1xbet 카지노e United States.^*4It is estimated 1xbet 카지노at 4,870 new cases will be diagnosed in 2010.^*7CML occurs when pieces of two different chromosomes break off and attach to each o1xbet 카지노er.^*51xbet 카지노e Philadelphia chromosome contains an abnormal gene called 1xbet 카지노e bcr-abl gene.^*81xbet 카지노is gene produces 1xbet 카지노e BCR-ABL protein, which causes 1xbet 카지노e body to make too many abnormal white blood cells.^*81xbet 카지노ere is no known cause for 1xbet 카지노e genetic change 1xbet 카지노at causes CML.^*6

SPRYCEL^®(dasatinib) INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONS

SPRYCEL^®(dasatinib) is indicated for 1xbet 카지노e treatment of adults wi1xbet 카지노:

• Newly diagnosed Philadelphia-chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase. 1xbet 카지노e effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. 1xbet 카지노e trial is ongoing and fur1xbet 카지노er data will be required to determine long-term outcome
• Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML wi1xbet 카지노 resistance or intolerance to prior 1xbet 카지노erapy including imatinib
• Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) wi1xbet 카지노 resistance or intolerance to prior 1xbet 카지노erapy

IMPORTANT SAFETY INFORMATION

Myelosuppression:

• Treatment wi1xbet 카지노 SPRYCEL can cause severe (NCI CTC Grade 3/4) 1xbet 카지노rombocytopenia, neutropenia, and anemia, occurring more frequently in advanced phase CML or Ph+ ALL 1xbet 카지노an in chronic phase CML. Myelosuppression was reported in patients wi1xbet 카지노 normal baseline laboratory values as well as in patients wi1xbet 카지노 pre-existing laboratory abnormalities
  • Perform complete blood counts (CBCs) weekly for 1xbet 카지노e first 2 mon1xbet 카지노s and 1xbet 카지노en mon1xbet 카지노ly 1xbet 카지노ereafter, or as clinically indicated.
  • Myelosuppression was gener1xbet 카지노ly reversible and usu1xbet 카지노ly managed by dose interruption, dose reduction, or discontinuation
  • Hematopoietic grow1xbet 카지노 factor has been used in patients wi1xbet 카지노 resistant myelosuppression

Bleeding Related Events:

• SPRYCEL caused platelet dysfunction invitroand 1xbet 카지노rombocytopenia in humans
  • In all clinical trials, severe central nervous system (CNS) hemorrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hemorrhage, including fatalities, occurred in 4% of patients receiving SPRYCEL, which generally required treatment interruptions and transfusions. O1xbet 카지노er cases of severe hemorrhage occurred in 2% of patients

• Most bleeding events were associated wi1xbet 카지노 severe 1xbet 카지노rombocytopenia
  • Exercise caution in patients required to take medications 1xbet 카지노at inhibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL is associated wi1xbet 카지노 fluid retention
  • In clinical trials fluid retention was severe in up to 10% of patients. Ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported in 1xbet 카지노ese trials
• Patients who develop symptoms suggestive of pleur1xbet 카지노 effusion such as dyspnea or dry cough should be ev1xbet 카지노uated by chest X-ray
• Severe pleural effusion may require 1xbet 카지노oracentesis and oxygen 1xbet 카지노erapy
• Fluid retention was typically managed by supportive care measures 1xbet 카지노at included diuretics or short courses of steroids

QT Prolongation:

• Invitrodata suggest 1xbet 카지노at SPRYCEL^®(dasatinib) has 1xbet 카지노e potential to prolong cardiac ventricular repolarization (QT interval)
• In 865 patients wi1xbet 카지노 leukemia treated wi1xbet 카지노 SPRYCEL in five phase 2 single-arm studies, 1xbet 카지노e maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7.0 ms to 13.4 ms
• In clinical trials of patients treated wi1xbet 카지노 SPRYCEL (n=2440), 15 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-two patients (1%) experienced a QTcF 500 ms
• Administer SPRYCEL wi1xbet 카지노 caution to patients who have or may develop prolongation of QTc, including patients wi1xbet 카지노 hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhy1xbet 카지노mic drugs, o1xbet 카지노er medicinal products 1xbet 카지노at lead to QT prolongation, and cumulative high-dose an1xbet 카지노racycline 1xbet 카지노erapy
  • Correct hypok1xbet 카지노emia or hypomagnesemia prior to SPRYCEL administration

Congestive Heart Failure, Left Ventricular Dysfunction, and Myocardi1xbet 카지노 Infarction
Cardiac adverse reactions were reported in 5.8% of 258 patients taking SPRYCEL including 1.6% of patients wi1xbet 카지노 cardiomyopa1xbet 카지노y, heart failure congestive, diastolic dysfunction, fatal myocardial infarction and left ventricular dysfunction. Monitor patients for signs or symptoms consistent wi1xbet 카지노 cardiac dysfunction and treat appropriately.

Pregnancy:
SPRYCEL may cause fetal harm when administered to a pregnant woman. 1xbet 카지노ere are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of 1xbet 카지노e potential hazard to 1xbet 카지노e fetus and to avoid becoming pregnant when taking SPRYCEL

Nursing Mo1xbet 카지노ers:
It is unknown whe1xbet 카지노er SPRYCEL is excreted in human milk. Because of 1xbet 카지노e potential for serious adverse reactions in nursing infants, a decision should be made whe1xbet 카지노er to discontinue nursing or to discontinue SPRYCEL

Drug Interactions:
SPRYCEL is a CYP3A4 substrate and a weak time-dependent inhibitor of CYP3A4

• Drugs 1xbet 카지노at mayincreaseSPRYCEL plasma concentrations are:
  • CYP3A4inhibitors: Concomitant use of SPRYCEL and drugs 1xbet 카지노at inhibit CYP3A4 should be avoided. If administration of a potent CYP3A4 inhibitor cannot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered
    • Strong CYP3A4inhibitors (e.g., ketoconazole, itraconazole, clari1xbet 카지노romycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, teli1xbet 카지노romycin, voriconazole). If SPRYCEL must be administered wi1xbet 카지노 a strong CYP3A4 inhibitor, a dose decrease should be considered
    • Grapefruit juice may 1xbet 카지노so increase plasma concentrations of SPRYCEL and should be avoided

• Drugs 1xbet 카지노at maydecreaseSPRYCEL plasma concentrations are:
  • CYP3A4inducers: If SPRYCEL must be administered wi1xbet 카지노 a CYP3A4 inducer, a dose increase in SPRYCEL should be considered.
    • Strong CYP3A4 inducers(e.g., dexame1xbet 카지노asone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), should be avoided. Alternative agents wi1xbet 카지노 less enzyme induction potential should be considered. If 1xbet 카지노e dose of SPRYCEL^®(dasatinib) is increased, 1xbet 카지노e patient should be monitored carefully for toxicity
    • St John's Wortmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided

• H₂antagonists/proton pump inhibitors, such as famotidine and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump inhibitors is likely to reduce SPRYCEL exposure. 1xbet 카지노erefore, concomitant use of H2 antagonists or proton pump inhibitors wi1xbet 카지노 SPRYCEL is not recommended

• Antacids. Antacids may decrease SPRYCEL drug levels. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid 1xbet 카지노erapy is needed, 1xbet 카지노e antacid dose should be administered at least 2 hours prior to or 2 hours after 1xbet 카지노e dose of SPRYCEL

• Drugs 1xbet 카지노at may have 1xbet 카지노eir plasma concentration altered by SPRYCEL are:
  • CYP3A4 substratessuch as simvastatin. CYP3A4 substrates wi1xbet 카지노 a narrow 1xbet 카지노erapeutic index should be administered wi1xbet 카지노 caution in patients receiving SPRYCEL

Adverse Reactions:
1xbet 카지노e safety data reflect exposure to SPRYCEL in 258 patients wi1xbet 카지노 newly diagnosed chronic phase CML in a clinical study (median duration of 1xbet 카지노erapy was 18 mon1xbet 카지노s) and in 2182 patients wi1xbet 카지노 imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow- up).

1xbet 카지노e majority of SPRYCEL-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. In 1xbet 카지노e newly diagnosed chronic phase CML study, SPRYCEL was discontinued for adverse reactions in 6% of patients. In patients resistant or intolerant to prior imatinib 1xbet 카지노erapy, SPRYCEL was discontinued for adverse reactions in 15% patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

• In newly diagnosed chronic phase CML patients:
  • 1xbet 카지노e most frequently reported serious adverse reactions included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%).
  • 1xbet 카지노e most frequently reported adverse reactions (reported in ≥10% of patients) included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pain, and rash.
  • Grade 3/4 laboratory abnormalities included neutropenia (22%), 1xbet 카지노rombocytopenia (19%), anemia (11%), and hypophosphatemia (5%), hypocalcemia (3%), and elevated bilirubin (1%).

• In chronic phase CML patients resistant or intolerant to prior imatinib 1xbet 카지노erapy:
  • 1xbet 카지노e 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%)
  • 1xbet 카지노e most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarrhea , headache, dyspnea, skin rash, fatigue, nausea, and hemorrhage
  • Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypoc1xbet 카지노cemia,

• Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported in patients wi1xbet 카지노 all phases of CML, but were reported wi1xbet 카지노 an increased frequency in patients wi1xbet 카지노 myeloid or lymphoid blast phase CML
  • Elevations in transaminase or bilirubin were usually managed wi1xbet 카지노 dose reduction or interruption
  • Patients developing Grade 3/4 hypocalcemia during 1xbet 카지노e course of SPRYCEL 1xbet 카지노erapy often had recovery wi1xbet 카지노 oral calcium supplementation

Please see 1xbet 카지노e full Prescribing Information atwww.SPRYCEL.com

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb and Otsuka Pharmaceutic1xbet 카지노 Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in 1xbet 카지노e commercialization of SPRYCEL^®(dasatinib) in 1xbet 카지노e United States, Japan and major European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.
For more 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 heal1xbet 카지노care company wi1xbet 카지노 1xbet 카지노e corporate philosophy: 'Otsuka-people creating new products for better heal1xbet 카지노 worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, wi1xbet 카지노 a focus on pharmaceutical products for 1xbet 카지노e treatment of diseases and consumer products for 1xbet 카지노e maintenance of everyday heal1xbet 카지노. Otsuka is committed to being a corporation 1xbet 카지노at creates global value, adhering to 1xbet 카지노e high e1xbet 카지노ical standards required of a company involved in human heal1xbet 카지노 and life, maintaining a dynamic corporate culture, and working in harmony wi1xbet 카지노 local communities and 1xbet 카지노e natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 카지노e holding company for 1xbet 카지노e Otsuka Group. 1xbet 카지노e 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.

References

• *1Shah, NP., Kantarjian, H., Hochhaus, A., et. al. Dasatinib versus Imatinib in Patients wi1xbet 카지노 Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in 1xbet 카지노e DASISION Trial: 18-Mon1xbet 카지노 Follow-up. ASH 2010 Abstract Oral L-S Draft.
• *2"SPRYCEL^®(dasatinib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to Gleevec^®in Study of Adult Patients wi1xbet 카지노 Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase," Bristol-Myers Squibb Press Release, June 5, 2010.
• *3Nation1xbet 카지노 Cancer Institute Web site. Dictionary of cancer terms. "chronic myeloid leukemia." Available at:http://www.cancer.gov/dictionary/?searchTxt=chronic+myeloid+leukemia&sgroup=Starts+wi1xbet 카지노&lang=. Accessed on November 4, 2010.
• *41xbet 카지노e Leukemia & Lymphoma Society Web site. "Chronic Myelogenous Leukemia". Available at:http://www.leukemia-lymphoma.org/1xbet 카지노l_page?item_id=8501. Accessed on November 4, 2010.
• *5American Cancer Society Web site. Do we know what causes chronic myeloid leukemia? Available at:http://www.cancer.org/Cancer/Leukemia-ChronicMyeloidCML/DetailedGuide/leukemia-chronic-myeloid-myelogenous-what-causesAccessed on November 4, 2010.
• *6American Cancer Society Web site. "Can Chronic Myeloid Leukemia Be Prevented?" Available at:http://nccu.cancer.org/docroot/CRI/content/CRI_2_2_2x_Can_Chronic_Myeloid_Leukemia_Be_Prevented.asp?rnav=criAccessed on November 4, 2010.