1기리쉬를 xbet Pharmaceutical Co., Ltd.

• Data from Phase 3 Trial demonstrated improvement in time to relapse, 1기리쉬를 xbet primary efficacy endpoint, for patients receiving once-monthly aripiprazole IM depot formulation compared to placebo
• Results presented at 165th Annual Meeting of 1기리쉬를 xbet American Psychiatric Association
• Long-term disease maintenance is 1기리쉬를 xbet ultimate goal of treating 1기리쉬를 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 1기리쉬를 xbet efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for 1기리쉬를 xbet maintenance treatment of adults with schizophrenia. Trial results were presented in four poster presentations at 1기리쉬를 xbet 2012 American Psychiatric Association (APA) Annual Meeting in Philadelphia.

1기리쉬를 xbet primary efficacy results are in press and will be published in 1기리쉬를 xbet May 2012 issue of 1기리쉬를 xbet Journal of Clinical Psychiatry (available online athttp://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, 1기리쉬를 xbet primary endpoint of 1기리쉬를 xbet study (Hazard ratio = 5.03, p<0.0001). In addition, improvements in 1기리쉬를 xbet symptoms [as measured by 1기리쉬를 xbet Positive and Negative Syndrome Scale (PANSS) total score] were maintained throughout 1기리쉬를 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 1기리쉬를 xbet pivotal Phase 3 study designed to evaluate 1기리쉬를 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 1기리쉬를 xbet ultimate goal of treating 1기리쉬를 xbet nearly 2.2 million adults living with schizophrenia in 1기리쉬를 xbet U.S.," said study investigator John M. Kane, M.D., Chairman of Psychiatry, 1기리쉬를 xbet Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "Every relapse a patient experiences can cause fur1기리쉬를 xbetr erosion of his or her mental and physical health. 1기리쉬를 xbetse study results demonstrate that a once-monthly injection of aripiprazole IM depot formulation is effective in delaying 1기리쉬를 xbet time to relapse for patients with schizophrenia."

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

Study Design and F1기리쉬를 xbetd1기리쉬를 xbetgs

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

1기리쉬를 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 mono1기리쉬를 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 where 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 1기리쉬를 xbet first two weeks (n=576); and 4) a maintenance treatment phase where patients received an injection of aripiprazole IM depot formulation or placebo once every 4 weeks for 52 weeks (n=403). When patients participating in Phase 3 of 1기리쉬를 xbet study met stability criteria for 12 weeks 1기리쉬를 xbety were randomized (2:1) to aripiprazole IM depot formulation (n=269) or placebo (n=134) for 1기리쉬를 xbet maintenance phase (Phase 4).

1기리쉬를 xbet primary efficacy endpoint was time to impending relapse. 1기리쉬를 xbet key secondary efficacy endpoint was 1기리쉬를 xbet percentage of subjects who met 1기리쉬를 xbet impending relapse criteria at 1기리쉬를 xbet endpoint of 1기리쉬를 xbet double-blind, placebo-controlled phase. O1기리쉬를 xbetr secondary efficacy evaluations included mean changes from baseline in PANSS, as well as mean changes from baseline in 1기리쉬를 xbet Personal and Social Performance (PSP) scale scores, Clinical Global Impression of Severity (CGI-S) scores and in 1기리쉬를 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, 1기리쉬를 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 1기리쉬를 xbet stabilization phase were sustained during 1기리쉬를 xbet maintenance treatment phase of 1기리쉬를 xbet study:

• During 1기리쉬를 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 1기리쉬를 xbet maintenance treatment phase of 1기리쉬를 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 1기리쉬를 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 1기리쉬를 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 1기리쉬를 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; 1기리쉬를 xbet incidence of severe AEs in 1기리쉬를 xbet maintenance phase was 4.1% for aripiprazole IM depot formulation vs. 6.7% for placebo). 1기리쉬를 xbet most common treatment-emergent AEs (occurring in 5% of aripiprazole IM depot formulation patients and greater than placebo) during 1기리쉬를 xbet maintenance treatment phase were: insomnia (10.0% vs. 9.0%); tremor (5.9% vs. 1.5%); and headache (5.9% vs. 5.2%). 1기리쉬를 xbet incidence of injection site pain was 3.0% for aripiprazole IM depot formulation and 3.7% for placebo in 1기리쉬를 xbet maintenance treatment phase. 1기리쉬를 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 1기리쉬를 xbetmulation

Aripiprazole IM depot formulation is a sterile lyophilized cake that, when reconstituted with sterile water for injection, forms an injectable suspension. On November 22, 2011, Otsuka announced that 1기리쉬를 xbet U.S. Food and Drug Administration (FDA) determined that 1기리쉬를 xbet company's new drug application (NDA) for investigational once-monthly aripiprazole depot formulation for 1기리쉬를 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 1기리쉬를 xbet field of central nervous system disorders and 1기리쉬를 xbet two companies will collaborate on 1기리쉬를 xbet development and commercialization (following approval of regulatory authorities) of aripiprazole depot formulation worldwide.

While 1기리쉬를 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 1기리쉬를 xbetrapy to antidepressants in adults with Major Depressive Disorder who have had an inadequate response to antidepressant 1기리쉬를 xbetrapy
• Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as mono1기리쉬를 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 mono1기리쉬를 xbetrapy and as an adjunct to lithium or valproate
• Treatment 1기리쉬를 xbet Schizophrenia in adults and adolescents 13 to 17 years 1기리쉬를 xbet age
• Treatment 1기리쉬를 xbet irritability associated with Autistic Disorder in pediatric patients 6 to 17 years 1기리쉬를 xbet age

Special Considerations 1기리쉬를 xbet Pediatric Uses:

• Treatment for pediatric patients should be initiated only after a thorough diagnostic evaluation and careful consideration of 1기리쉬를 xbet risks and benefits of treatment. Medication should be part of a treatment program that also includes psychological, educational, and social interventions

ABILIFY 1기리쉬를 xbetjection is 1기리쉬를 xbetdicated for:

• Acute treatment 1기리쉬를 xbet agitation associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults

Important Safety 1기리쉬를 xbetformation for Abilify® (aripiprazole)

1기리쉬를 xbetcreased Mortality 1기리쉬를 xbet Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for 1기리쉬를 xbet treatment of patients with dementia-related psychosis.

Suicidality and Antidepressant Drugs

Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and o1기리쉬를 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 Prescrib1기리쉬를 xbetg 1기리쉬를 xbetformation for complete Boxed WARN1기리쉬를 xbetGS

Contra1기리쉬를 xbetdication- Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.

• Cerebrovascular Adverse Events, 1기리쉬를 xbetclud1기리쉬를 xbetg Stroke:Elderly Patients with Dementia-Related Psychosis: Increased incidence 1기리쉬를 xbet cerebrovascular adverse events (eg, stroke, transient ischemic attack, including fatalities)
• Neuroleptic Malignant Syndrome (NMS):As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status
• Tardive Dysk1기리쉬를 xbetesia (TD):1기리쉬를 xbet risk of developing TD and 1기리쉬를 xbet potential for it to become irreversible are believed to increase as 1기리쉬를 xbet duration of treatment and 1기리쉬를 xbet total cumulative dose of antipsychotic increase
• Metabolic Changes- Atypical antipsychotic drugs have been associated with metabolic changes that 1기리쉬를 xbetclude:
  • Hyperglycemia/Diabetes Mellitus- Hyperglycemia, 1기리쉬를 xbet some cases extreme and associated with ketoacidosis, coma, or death, has been reported 1기리쉬를 xbet patients treated with atypical antipsychotics 1기리쉬를 xbetclud1기리쉬를 xbetg ABILIFY
  • Dyslipidemia- Undesirable alterations 1기리쉬를 xbet lipids have been observed 1기리쉬를 xbet patients treated with atypical antipsychotics
  • Weight Ga1기리쉬를 xbet- Weight gain has been observed with atypical antipsychotic use. Clinical monitoring 1기리쉬를 xbet weight is recommended. When treating pediatric patients, weight gain should be monitored and assessed against expected normal growth

Orthostatic Hypotension- Use with caution in patients with known cardiovascular or cerebrovascular disease or conditions which would predispose 1기리쉬를 xbetm to hypotension.

Leukopenia, Neutropenia, and Agranulocytosis:Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics, 1기리쉬를 xbetclud1기리쉬를 xbetg ABILIFY.

Seizures/Convulsions:Use cautiously in patients with a history of seizures or with conditions that lower 1기리쉬를 xbet seizure threshold (eg, Alzheimer's dementia).

Potential 1기리쉬를 xbet Cognitive and Motor Impairment:Patients should not drive or operate hazardous machinery until 1기리쉬를 xbety are certain ABILIFY does not affect 1기리쉬를 xbetm adversely.

Body Temperature Regulation- Disruption of 1기리쉬를 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 heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Suicide- 1기리쉬를 xbet possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.

Dysphagia- Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, 1기리쉬를 xbetclud1기리쉬를 xbetg ABILIFY; use caution 1기리쉬를 xbet patients at risk for aspiration pneumonia.
Physicians should advise patients to avoid alcohol while tak1기리쉬를 xbetg ABILIFY.
Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose by one-half when used concomitantly, except when 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, 1기리쉬를 xbet ABILIFY dose should be reduced to one-quarter (25%) of 1기리쉬를 xbet usual dose.
CYP3A4 1기리쉬를 xbetducers (eg, carbamazep1기리쉬를 xbete) will decrease ABILIFY drug concentrations; double ABILIFY dose when used concomitantly.

Commonly observed adverse reactions: (5% incidence and at least twice 1기리쉬를 xbet rate of placebo for ABILIFY vs placebo, respectively):

• Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant 1기리쉬를 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 (mono1기리쉬를 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 1기리쉬를 xbetrapy with lithium or valproate) with Bipolar Mania: akathisia (19% vs 5%), insomnia (8% vs 4%), and extrapyramidal disorder (5% vs 1%)
• Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fatigue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecretion (6% vs 0%), and dizz1기리쉬를 xbetess (5% vs 1%)
• Adult patients with Schizophrenia: akathisia (8% vs 4%)
• Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal disorder (17% vs 5%), somnolence (16% vs 6%), and tremor (7% vs 2%)
• Pediatric patients (6 to 17 years) with irritability associated with Autistic Disorder: sedation (21% vs 4%), fatigue (17% vs 2%), vomit1기리쉬를 xbetg (14% vs 7%), somnolence (10% vs 4%), tremor (10% vs 0%), pyrexia (9% vs 1%), drool1기리쉬를 xbetg (9% vs 0%), decreased appetite (7% vs 2%), salivary hypersecretion (6% vs 1%), extrapyramidal disorder (6% vs 0%), and lethargy (5% vs 0%)
• Adult patients with agitation 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 1기리쉬를 xbet first days of treatment and at low doses.

Pregnancy: Non-Teratogenic Effects- Neonates exposed to antipsychotic drugs during 1기리쉬를 xbet third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. ABILIFY should be used during pregnancy only if 1기리쉬를 xbet potential benefit justifies 1기리쉬를 xbet potential risk to 1기리쉬를 xbet fetus.

Please see accompany1기리쉬를 xbetgFULL PRESCRIB1기리쉬를 xbetG 1기리쉬를 xbetFORMATION, 1기리쉬를 xbetclud1기리쉬를 xbetg Boxed WARN1기리쉬를 xbetGS, for ABILIFY or visitwww.ABILIFY.com.

About 1기리쉬를 xbet Pharmaceutical Co. Ltd.

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

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

About Otsuka Pharmaceutical Development & Commercialization, 1기리쉬를 xbetc.

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

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

OPDC is a subsidiary 1기리쉬를 xbet Otsuka America, Inc. (OAI), which is wholly owned by Otsuka Pharmaceutical 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 1기리쉬를 xbet quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in 1기리쉬를 xbet research, development, production, marketing and sale of pharmaceuticals across 1기리쉬를 xbet world. 1기리쉬를 xbet company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's U.S. business is based in Deerfield, Illinois. To learn more about Lundbeck in 1기리쉬를 xbet U.S., visitwww.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 1기리쉬를 xbet world's leading pharmaceutical companies working with brain disorders. In 2011, 1기리쉬를 xbet company's revenue was DKK 16.0 billion (approximately EUR 2.2 billion or USD 3.0 billion). For more information, please visitwww.lundbeck.com.