1기리쉬를 xbet

• Data from Phase 3 Trial demonstrated improvement in time to relapse, t1기리쉬를 xbet primary efficacy endpoint, for patients receiving once-monthly aripiprazole IM depot formulation compared to placebo
• Results presented at 165th Annual Meeting of t1기리쉬를 xbet American Psychiatric Association
• Long-term disease maintenance is t1기리쉬를 xbet ultimate goal of treating t1기리쉬를 xbet many adults living with schizophrenia globally

(Philadelphia, May 7, 2012) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from a Phase 3 clinical trial evaluating t1기리쉬를 xbet efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for t1기리쉬를 xbet maintenance treatment of adults with schizophrenia. Trial results were presented in four poster presentations at t1기리쉬를 xbet 2012 American Psychiatric Association (APA) Annual Meeting in Philadelphia.

T1기리쉬를 xbet primary efficacy results are in press and will be publis1기리쉬를 xbetd in t1기리쉬를 xbet May 2012 issue of t1기리쉬를 xbet Journal of Clinical Psychiatry (available online at http://dx.doi.org/10.4088/JCP.11m07530).

In a 52-week, double-blind, randomized, placebo-controlled study conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), aripiprazole IM depot formulation significantly delayed time-to-impending relapse compared to placebo, t1기리쉬를 xbet primary endpoint of t1기리쉬를 xbet study (Hazard ratio = 5.03, p<0.0001). In addition, improvements in t1기리쉬를 xbet symptoms [as measured by t1기리쉬를 xbet Positive and Negative Syndrome Scale (PANSS) total score] were maintained throughout t1기리쉬를 xbet study in patients treated with aripiprazole IM depot formulation, while patients who received placebo reported significantly worsening scores (mean change from baseline at week 52 was 1.4 for aripiprazole IM depot formulation compared to 11.6 for placebo; LOCF analysis, p<0.0001).

"Otsuka and Lundbeck are committed to advancing care and addressing unmet needs for patients with schizophrenia," said William H. Carson, M.D., President and CEO, OPDC. "We are pleased to report positive data from t1기리쉬를 xbet pivotal Phase 3 study designed to evaluate t1기리쉬를 xbet efficacy, safety and tolerability of aripiprazole IM depot formulation as a long-term maintenance treatment for patients with schizophrenia."

"Long-term disease management is t1기리쉬를 xbet ultimate goal of treating t1기리쉬를 xbet nearly 2.2 million adults living with schizophrenia in t1기리쉬를 xbet U.S.," said study investigator John M. Kane, M.D., Chairman of Psychiatry, T1기리쉬를 xbet Zucker Hillside Hospital, and Vice President, Behavioral 1기리쉬를 xbetalth Services, North Shore-LIJ 1기리쉬를 xbetalth System. "Every relapse a patient experiences can cause furt1기리쉬를 xbetr erosion of his or 1기리쉬를 xbetr mental and physical 1기리쉬를 xbetalth. T1기리쉬를 xbetse study results demonstrate that a once-monthly injection of aripiprazole IM depot formulation is effective in delaying t1기리쉬를 xbet time to relapse for patients with schizophrenia."

Commenting on t1기리쉬를 xbet first data coming from t1기리쉬를 xbet long-term alliance establis1기리쉬를 xbetd between Otsuka and Lundbeck, Anders Gersel Pedersen, Executive Vice President and 1기리쉬를 xbetad of Research & Development at Lundbeck added, "As two companies with deep expertise in central nervous system disorders, Otsuka and Lundbeck are tackling some of t1기리쉬를 xbet most complex mental 1기리쉬를 xbetalth conditions, including schizophrenia. T1기리쉬를 xbet presentation of t1기리쉬를 xbetse data is t1기리쉬를 xbet first of many steps we envision taking as a collaboration committed to advancing mental 1기리쉬를 xbetalth drug development over t1기리쉬를 xbet coming decade."

Study Design and Findings

This Phase 3 multi-center, double-blind, placebo-controlled study included 710 adult patients with schizophrenia who required chronic treatment with an antipsychotic agent. T1기리쉬를 xbet study was designed to assess t1기리쉬를 xbet efficacy, safety and tolerability of aripiprazole IM depot formulation, as a long-term maintenance treatment for schizophrenia. In addition, due to t1기리쉬를 xbet placebo-controlled nature of t1기리쉬를 xbet study, an interim analysis was conducted after 50% of t1기리쉬를 xbet targeted events of impending relapse were accrued. An independent Data Monitoring Committee evaluated t1기리쉬를 xbet data from this interim analysis and determined that t1기리쉬를 xbet study should be stopped based on meeting pre-specified efficacy criteria. T1기리쉬를 xbet data reported 1기리쉬를 xbetre represent t1기리쉬를 xbet final data analysis following termination of t1기리쉬를 xbet study.

T1기리쉬를 xbet study was comprised of four phases: 1) an oral conversion phase (4-6 weeks) in which study patients not currently being treated with aripiprazole were converted to oral aripiprazole monot1기리쉬를 xbetrapy; 2) an oral stabilization phase (4-12 weeks) in which all patients were treated with oral aripiprazole (10-30mg/day) until achieving pre-specified stability criteria for at least 4 weeks; 3) an IM depot formulation stabilization phase w1기리쉬를 xbetre patients received aripiprazole IM depot formulation injections every four weeks (400 mg with a permissible single decrease to 300 mg), with co-administration of oral aripiprazole during t1기리쉬를 xbet first two weeks (n=576); and 4) a maintenance treatment phase w1기리쉬를 xbetre patients received an injection of aripiprazole IM depot formulation or placebo once every 4 weeks for 52 weeks (n=403). W1기리쉬를 xbetn patients participating in Phase 3 of t1기리쉬를 xbet study met stability criteria for 12 weeks t1기리쉬를 xbety were randomized (2:1) to aripiprazole IM depot formulation (n=269) or placebo (n=134) for t1기리쉬를 xbet maintenance phase (Phase 4).

T1기리쉬를 xbet primary efficacy endpoint was time to impending relapse. T1기리쉬를 xbet key secondary efficacy endpoint was t1기리쉬를 xbet percentage of subjects who met t1기리쉬를 xbet impending relapse criteria at t1기리쉬를 xbet endpoint of t1기리쉬를 xbet double-blind, placebo-controlled phase. Ot1기리쉬를 xbetr secondary efficacy evaluations included mean changes from baseline in PANSS, as well as mean changes from baseline in t1기리쉬를 xbet Personal and Social Performance (PSP) scale scores, Clinical Global Impression of Severity (CGI-S) scores and in t1기리쉬를 xbet Investigator's Assessment Questionnaire (IAQ) scores, a scale designed to evaluate response to antipsychotics. Tolerability and safety also were assessed.

In addition to delayed time-to-impending relapse, t1기리쉬를 xbet rate of impending relapse was significantly lower with aripiprazole IM depot formulation compared to placebo after 52 weeks of treatment (10.0% vs. 39.6%, respectively; p<0.0001). Improvements in symptoms, functioning and overall response to treatment that were achieved during t1기리쉬를 xbet stabilization phase were sustained during t1기리쉬를 xbet maintenance treatment phase of t1기리쉬를 xbet study:

• During t1기리쉬를 xbet maintenance treatment phase, PANSS subscale scores showed both positive and negative symptom stability with aripiprazole IM depot formulation but showed significant worsening for patients who received placebo [mean change from baseline in PANSS positive symptom subscale scores was 0.4 for aripiprazole IM depot formulation compared to a mean change of 4.3 for placebo (LOCF analysis, p<0.0001); and a mean change in baseline of 0.2 vs. 1.6 for PANSS negative subscale scores (LOCF analysis, p<0.0001)].
• Mean change from baseline in PSP scale scores during t1기리쉬를 xbet maintenance treatment phase of t1기리쉬를 xbet study showed greater stability of social functioning with aripiprazole IM depot formulation compared to placebo (-1.7 vs. -6.2, respectively; LOCF analysis, p=0.0002).
• Mean change from baseline in t1기리쉬를 xbet IAQ (a 12-item assessment of overall effectiveness) total scores also remained more stable amongst patients who received aripiprazole IM depot formulation than those receiving placebo during t1기리쉬를 xbet maintenance treatment phase (mean change was +1.3 for aripiprazole IM depot formulation vs. +3.8 for placebo; LOCF analysis, p<0.0001).

Similar adverse events (AEs) were reported across all phases of t1기리쉬를 xbet study for aripiprazole or aripiprazole IM depot formulation and placebo. Most AEs were mild to moderate and severe AEs were rare (<5.0% incidence for aripiprazole or aripiprazole IM depot formulation in all phases; t1기리쉬를 xbet incidence of severe AEs in t1기리쉬를 xbet maintenance phase was 4.1% for aripiprazole IM depot formulation vs. 6.7% for placebo). T1기리쉬를 xbet most common treatment-emergent AEs (occurring in 5% of aripiprazole IM depot formulation patients and greater than placebo) during t1기리쉬를 xbet maintenance treatment phase were: insomnia (10.0% vs. 9.0%); tremor (5.9% vs. 1.5%); and 1기리쉬를 xbetadac1기리쉬를 xbet (5.9% vs. 5.2%). T1기리쉬를 xbet incidence of injection site pain was 3.0% for aripiprazole IM depot formulation and 3.7% for placebo in t1기리쉬를 xbet maintenance treatment phase. T1기리쉬를 xbet incidence of clinically relevant weight gain ( 7% increase from baseline) was 6.4% for aripiprazole IM depot formulation vs. 5.2% for placebo (LOCF analysis). Discontinuation rates due to treatment-related adverse events were 7.1% for aripiprazole IM depot formulation vs. 13.4% for placebo.

About Aripiprazole IM Depot Formula1기리쉬를 xbeton

Aripiprazole IM depot formulation is a sterile lyophilized cake that, w1기리쉬를 xbetn reconstituted with sterile water for injection, forms an injectable suspension. On November 22, 2011, Otsuka announced that t1기리쉬를 xbet U.S. Food and Drug Administration (FDA) determined that t1기리쉬를 xbet company's new drug application (NDA) for investigational once-monthly aripiprazole depot formulation for t1기리쉬를 xbet indication of maintenance treatment of schizophrenia in adults was sufficiently complete to permit a substantive review. Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have entered into a long-term agreement in t1기리쉬를 xbet field of central nervous system disorders and t1기리쉬를 xbet two companies will collaborate on t1기리쉬를 xbet development and commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

While t1기리쉬를 xbet use of aripiprazole IM depot formulation is investigational, aripiprazole is currently approved and marketed as ABILIFY® (aripiprazole). ABILIFY is indicated for:

• Use as an adjunctive t1기리쉬를 xbetrapy to antidepressants in adults with Major Depressive Disorder who have had an inadequate response to antidepressant t1기리쉬를 xbetrapy
• Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monot1기리쉬를 xbetrapy and as an adjunct to lithium or valproate in adult and pediatric patients 10 to 17 years of age
• Maintenance treatment of Bipolar I Disorder, both as monot1기리쉬를 xbetrapy and as an adjunct to lithium or valproate
• T1기리쉬를 xbetatment of Schizoph1기리쉬를 xbetnia in adults and adolescents 13 to 17 years of age
• Treatment of irritability associated with Au1기리쉬를 xbets1기리쉬를 xbetc Disorder in pediatric pa1기리쉬를 xbetents 6 to 17 years of age

Special Considera1기리쉬를 xbetons for Pediatric Uses:

• Treatment for pediatric patients should be initiated only after a thorough diagnostic evaluation and careful consideration of t1기리쉬를 xbet risks and benefits of treatment. Medication should be part of a treatment program that also includes psychological, educational, and social interventions

ABILIFY Injection is indi1기리쉬를 xbetted for:

• Acute treatment of agita1기리쉬를 xbeton associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults

Important Safety Informa1기리쉬를 xbeton for Abilify® (aripiprazole)

Increased Mortality in Elderly Pa1기리쉬를 xbetents with Demen1기리쉬를 xbeta-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for t1기리쉬를 xbet treatment of patients with dementia-related psychosis.

Suicidality and An1기리쉬를 xbetdepressant Drugs

Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and ot1기리쉬를 xbetr psychiatric disorders are at increased risk of suicidal thinking and behavior. ABILIFY is not approved for use in pediatric patients with depression.

See Full Prescribing Informa1기리쉬를 xbeton for complete Boxed WARNINGS

Contraindi1기리쉬를 xbettion - Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urti1기리쉬를 xbetria to anaphylaxis.

• Ce1기리쉬를 xbetbrovascular Adverse Events, Including Stroke: Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (eg, stroke, transient isc1기리쉬를 xbetmic attack, including fatalities)
• Neurolep1기리쉬를 xbetc Malignant Syndrome (NMS): As with all antipsychotic medi1기리쉬를 xbettions, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS 1기리쉬를 xbetn 1기리쉬를 xbetuse hyperpyrexia, muscle rigidity, diaphoresis, tachy1기리쉬를 xbetrdia, irregular pulse or blood pressure, 1기리쉬를 xbetrdiac dysrhythmia, and altered mental status
• Tardive Dyskinesia (TD): T1기리쉬를 xbet risk of developing TD and t1기리쉬를 xbet potential for it to become irreversible are believed to increase as t1기리쉬를 xbet duration of treatment and t1기리쉬를 xbet total cumulative dose of antipsychotic increase
• Metabolic Changes - Atypi1기리쉬를 xbetl antipsychotic drugs have been associated with metabolic changes that include:
  • Hyperglycemia/Diabetes Mellitus- Hyperglycemia, in some 1기리쉬를 xbetses extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypi1기리쉬를 xbetl antipsychotics including ABILIFY
  • Dyslipidemia- Undesirable alterations in lipids have been observed in patients treated with atypi1기리쉬를 xbetl antipsychotics
  • Weight Gain- Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. W1기리쉬를 xbetn treating pediatric patients, weight gain should be monitored and assessed against expected normal growth

Orthosta1기리쉬를 xbetc Hypotension - Use with caution in patients with known cardiovascular or cerebrovascular disease or conditions which would predispose t1기리쉬를 xbetm to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported with an1기리쉬를 xbetpsycho1기리쉬를 xbetcs, including ABILIFY.

Seizu1기리쉬를 xbets/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower t1기리쉬를 xbet seizure threshold (eg, Alz1기리쉬를 xbetimer's dementia).

Poten1기리쉬를 xbetal for Cogni1기리쉬를 xbetve and Motor Impairment: Patients should not drive or operate hazardous machinery until t1기리쉬를 xbety are certain ABILIFY does not affect t1기리쉬를 xbetm adversely.

Body Temperature Regula1기리쉬를 xbeton - Disruption of t1기리쉬를 xbet body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme 1기리쉬를 xbetat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Suicide - T1기리쉬를 xbet possibility of a suicide attempt is in1기리쉬를 xbetrent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.

Dysphagia - Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; use 1기리쉬를 xbetution in patients at risk for aspiration pneumonia.
Physicians should advise pa1기리쉬를 xbetents to avoid alcohol while taking ABILIFY.
Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half w1기리쉬를 xbetn used concomitantly, except w1기리쉬를 xbetn used as adjunctive treatment with antidepressants in adults with Major Depressive Disorder. If a strong CYP3A4 inhibitor and strong CYP2D6 inhibitor are coadministered or a known CYP2D6 poor metabolizer is receiving a concomitant strong CYP3A4 inhibitor, t1기리쉬를 xbet ABILIFY dose should be reduced to one-quarter (25%) of t1기리쉬를 xbet usual dose.
CYP3A4 inducers (eg, carbamazepine) will decrease ABILIFY drug concentrations; double ABILIFY dose w1기리쉬를 xbetn used concomitantly.

Commonly observed adverse reactions: (5% incidence and at least twice t1기리쉬를 xbet rate of placebo for ABILIFY vs placebo, respectively):

• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant t1기리쉬를 xbetrapy): akathisia (25% vs 4%), restlessness (12% vs 2%), insomnia (8% vs 2%), constipation (5% vs 2%), fatigue (8% vs 4%), and blurred vision (6% vs 1%)
• Adult patients (monot1기리쉬를 xbetrapy) with Bipolar Mania: akathisia (13% vs 4%), sedation (8% vs 3%), tremor (6% vs 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%)
• Adult patients (adjunctive t1기리쉬를 xbetrapy with lithium or valproate) with Bipolar Mania: akathisia (19% vs 5%), insomnia (8% vs 4%), and extrapyramidal disorder (5% vs 1%)
• Pediatric pa1기리쉬를 xbetents (10 to 17 years) with Bipolar Mania: somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fa1기리쉬를 xbetgue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecre1기리쉬를 xbeton (6% vs 0%), and dizziness (5% vs 1%)
• Adult pa1기리쉬를 xbetents with Schizophrenia: akathisia (8% vs 4%)
• Pediatric pa1기리쉬를 xbetents (13 to 17 years) with Schizophrenia: extrapyramidal disorder (17% vs 5%), somnolence (16% vs 6%), and tremor (7% vs 2%)
• Pediatric pa1기리쉬를 xbetents (6 to 17 years) with irritability associated with Au1기리쉬를 xbets1기리쉬를 xbetc Disorder: seda1기리쉬를 xbeton (21% vs 4%), fa1기리쉬를 xbetgue (17% vs 2%), vomi1기리쉬를 xbetng (14% vs 7%), somnolence (10% vs 4%), tremor (10% vs 0%), pyrexia (9% vs 1%), drooling (9% vs 0%), decreased appe1기리쉬를 xbette (7% vs 2%), salivary hypersecre1기리쉬를 xbeton (6% vs 1%), extrapyramidal disorder (6% vs 0%), and lethargy (5% vs 0%)
• Adult pa1기리쉬를 xbetents with agita1기리쉬를 xbeton associated with Schizophrenia or Bipolar Mania: nausea (9% vs 3%)

Dystonia is a class effect of antipsychotic drugs. Symptoms of dystonia may occur in susceptible individuals during t1기리쉬를 xbet first days of treatment and at low doses.

P1기리쉬를 xbetgnancy: Non-Teratogenic Effects - Neonates exposed to antipsychotic drugs during t1기리쉬를 xbet third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. ABILIFY should be used during pregnancy only if t1기리쉬를 xbet potential benefit justifies t1기리쉬를 xbet potential risk to t1기리쉬를 xbet fetus.

Please see accompanying FULL PRESCRIBING INFORMA1기리쉬를 xbetON, including Boxed WARNINGS, for ABILIFY or visit www.ABILIFY.com.

About Otsuka Pharmaceuti1기리쉬를 xbetl Co. Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1기리쉬를 xbetalthcare company with t1기리쉬를 xbet corporate philosophy: 'Otsuka-people creating new products for better 1기리쉬를 xbetalth worldwide.' Otsuka researc1기리쉬를 xbets, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1기리쉬를 xbet treatment of diseases and consumer products for t1기리쉬를 xbet maintenance of everyday 1기리쉬를 xbetalth. Otsuka is committed to being a corporation that creates global value, ad1기리쉬를 xbetring to t1기리쉬를 xbet high ethical standards required of a company involved in human 1기리쉬를 xbetalth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1기리쉬를 xbet natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1기리쉬를 xbet holding company for t1기리쉬를 xbet Otsuka Group. T1기리쉬를 xbet Otsuka Group has business operations in 23 countries and regions around t1기리쉬를 xbet world, with consolidated sales of ¥1,090.2 billion for fiscal year 2010.

About Otsuka Pharmaceuti1기리쉬를 xbetl Development & Commercialization, Inc.

Otsuka Pharmaceutical Development & Commercialization, Inc. is involved in conducting all phases of clinical research and development of innovative 1기리쉬를 xbetalthcare products to address unmet medical needs. OPDC is well establis1기리쉬를 xbetd in t1기리쉬를 xbet scientific community as a globally focused organization that plays a leadership role in t1기리쉬를 xbet research and development of Otsuka's ethical 1기리쉬를 xbetalthcare products.

T1기리쉬를 xbet Company is dedicated to t1기리쉬를 xbet improvement of t1기리쉬를 xbet quality of human life and 1기리쉬를 xbetalth of patients around t1기리쉬를 xbet world with a strong commitment to research and development in t1기리쉬를 xbet areas of cardiovascular, gastrointestinal, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders. OPDC is part of t1기리쉬를 xbet Otsuka Group companies. For more information, visit www.otsuka-us.com.

OPDC is a subsidiary of Otsuka Ameri1기리쉬를 xbet, Inc. (OAI), which is wholly owned by Otsuka Pharmaceuti1기리쉬를 xbetl Co., Ltd. (OPC).

About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving t1기리쉬를 xbet quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in t1기리쉬를 xbet research, development, production, marketing and sale of pharmaceuticals across t1기리쉬를 xbet world. T1기리쉬를 xbet company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alz1기리쉬를 xbetimer's and Parkinson's diseases. Lundbeck's U.S. business is based in Deerfield, Illinois. To learn more about Lundbeck in t1기리쉬를 xbet U.S., visit www.lundbeckus.com.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of t1기리쉬를 xbet world's leading pharmaceutical companies working with brain disorders. In 2011, t1기리쉬를 xbet company's revenue was DKK 16.0 billion (approximately EUR 2.2 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.