Otsuka Pharmaceutical and Lundbeck: Study Shows Effects of Treatment with ABILIFY MAINTENA™ (Aripiprazole) on Psychiatric Hospitalization Rates for Patients with Schizophrenia1

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from a preliminary analysis that showed statistically significant reductions (p<0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly ABILIFY MAINTENA™ (aripiprazole) – an extended-release injectable suspension formulation of aripiprazole – compared to previous treatment with daily standard-of-care (SOC) oral antipsychotics.¹ Relapse, or an acute exacerbation of the disease, can result in hospitalization.² It also has been reported that hospitalization may contribute to higher health care costs.³ These data were presented in a poster at the 166^th American Psychiatric Association (APA) Annual Meeting in San Francisco on May 21.¹

"While further data are needed to confirm these findings, these results are exciting," said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "Due to the nature of schizophrenia, patients are at high risk for hospitalization, which can often result from a disease relapse.² So the more we can improve the management of symptoms, the better for patients and society as a whole." ^{2, 4}

This multicenter, open-label, North American study used a mirror-image design to assess total psychiatric hospitalization rates – defined as proportion of patients with =1 inpatient psychiatric hospitalizations. The study was divided into two treatment periods: the first was a retrospective, six-month period assessing total psychiatric hospitalization rates in stable adult patients with schizophrenia treated with oral SOC antipsychotics; the second treatment period included these same patients who were then converted to treatment with ABILIFY MAINTENA (aripiprazole) once-monthly 400 mg for six months in the following prospective phases:¹

• Phase A (1-4 weeks): a conversion phase where patients cross-titrated from their current oral antipsychotic to oral aripiprazole;
• Phase B (24 weeks): an open-label treatment phase where patients received ABILIFY MAINTENA (400 mg with an option to decrease to 300 mg for tolerability). As part of the study design, patients also received concomitant oral aripiprazole for the first 14 days of Phase B and:
• Phase C: an ongoing extension phase.

A total of 183 patients entered the prospective Phase B of the study, with 121 completing = three months treatment with ABILIFY MAINTENA in Phase B. Total psychiatric hospitalization rates for the retrospective three-month analysis period in which patients received oral antipsychotics were 28.1 percent (n=34/121) compared to hospitalization rates of 6.6 percent (n=8/121) during the last three months of the prospective analysis period with ABILIFY MAINTENA (p<0.0001). Total psychiatric hospitalization rates for the retrospective six-month analysis period in which patients received oral antipsychotics were 41.5 percent (n=76/183) compared to hospitalization rates of 14.2 percent (n=26/183) for all patients who entered Phase B of the six-month prospective analysis period with ABILIFY MAINTENA (p<0.0001). The most common treatment-emergent adverse events with >5 percent incidence observed during the prospective Phase B were psychotic disorder (7.7 percent), insomnia (7.2 percent), akathisia (7.2 percent) and schizophrenia, paranoid type (5.5 percent). The incidence of weight change was 2.2 percent gained weight and 2.2 percent lost weight.¹

About Schizophrenia

Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and the condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the U.S., and approximately 24 million people worldwide.^5,6,7 In the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.^7,8

It has been reported that the financial burden of schizophrenia in the United States is estimated to be greater than that of all cancers.⁹ Based on the latest data (2002), excess direct health care costs of schizophrenia in the U.S. were approximately $22.7 billion, and included expenditures for hospitalization, as well as for physician and other professional services and medications.³ Additional U.S. 2002 data sets suggest approximately two schizophrenia-related hospitalizations can be estimated per every 1,000 adults per year,^{10, 11} with a mean cost of $18,300 per hospitalization.^{10, 12} Other studies assessing health care utilization have suggested that the use of long-acting injectable medications to treat schizophrenia may help reduce psychiatric hospitalizations^{13, 14} and associated costs.¹³

About ABILIFY MAINTENA™ (aripiprazole)

ABILIFY MAINTENA for extended-release injectable suspension, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is indicated for the treatment of schizophrenia in the US.

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

After an initial injection of ABILIFY MAINTENA along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of ABILIFY MAINTENA provide uninterrupted medication coverage for 30 days at a time. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time.^{15, 16}

The U.S. Food and Drug Administration (FDA) approved ABILIFY MAINTENA for the treatment of adults with schizophrenia on February 28, 2013. The product became available for prescribing in the U.S. on March 18, 2013.

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the 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 the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and for several decades has been active in research on tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group has business operations in 25 countries and regions around the world, with consolidated sales of approximately USD 13 billion (approximately € 10 billion) for fiscal year 2012 (4/1/2012-3/31/2013.) Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late-stage development programs. Lundbeck's U.S. business is based in Deerfield, Illinois. To learn more about Lundbeck in the U.S., visit www.lundbeckus.com.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in Denmark. We have research in 57 countries and our products are registered in more than 100 countries. We have research centers in Denmark, China and the United States and production facilities in Italy, France, Mexico, China and Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012. For additional information, we encourage you to visit our corporate site www.lundbeck.com.

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