Otsuka and Lundbeck to Present Data on Investigational Compound Brexpiprazole in Schizophrenia and Major Depressive Disorder at American Psychiatric Association Annual Meeting

Tokyo, Japan and Deerfield, Ill. – May 12, 2015 – Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck today announced the presentation of several posters highlighting pre-clinical and clinical trial data for brexpiprazole, a novel investigational compound currently under review by the FDA as a potential monotherapy in adults with schizophrenia and as an adjunctive therapy in adults with major depressive disorder. The eight posters will be presented during the upcoming American Psychiatric Association (APA) annual meeting in Toronto, Canada, May 16-20. “Previously presented pivotal phase 3 clinical data provided an important foundation for establishing the efficacy and safety of brexpiprazole in affected patient populations,” said Robert McQuade, executive vice president and chief strategic officer, Otsuka America Pharmaceutical, Inc. “The data being presented at APA further demonstrate our robust clinical trial program and showcase the potential utility of this investigational compound in treating serious mental illnesses.” The following posters are slated for presentation:

Abstracts involving brexpiprazole in Major Depressive Disorder

All posters will be presented on Tuesday, May 19, from 2-4 p.m. ET in Toronto Convention Center South, Level 800 (Exhibit Hall D-E)
  • (Poster # P8-056): Effect of adjunctive brexpiprazole (OPC-34712) on depressive symptoms in patients with symptoms of anxious distress: results from post-hoc analyses. R. McIntyre.
  • (Poster # P8-043): Efficacy and safety of brexpiprazole (OPC-34712) as adjunctive treatment in major depressive disorder: Meta-analysis of two pivotal studies. H. Eriksson.
  • (Poster # P8-040): Adjunctive brexpiprazole (OPC-34712) in patients with major depressive disorder and anxiety symptoms: an exploratory study. L. Davis.
  • (Poster # P8-109): Brexpiprazole shows antidepressant- and anxiolytic-like effects in the rat forced swim and Vogel conflict tests. L. Lerdrup.
  • (Poster # P8-058): Long-term safety of adjunctive brexpiprazole (OPC-34712) in MDD: results from two 52-week open-label studies. C. Nelson.

Abstracts involving brexpiprazole in Schizophrenia

All posters will be presented on Monday, May 18, from 2-4 p.m. ET in Toronto Convention Center South, Level 800 (Exhibit Hall D-E)
  • (Poster # P6-102): Efficacy of brexpiprazole (OPC-34712) on PANSS items and Marder Factor scores: a meta-analysis of two pivotal studies in schizophrenia. S. Marder.
  • (Poster # P6-110): Efficacy and safety of brexpiprazole (OPC-34712) in acute schizophrenia: a pooled analysis of two pivotal studies. A. Skuban.
  • (Poster # P6-085): The effect of brexpiprazole (OPC-34712) versus aripiprazole in adult patients with acute schizophrenia: an exploratory study.
For more information about APA, please refer to http://annualmeeting.psychiatry.org/.

About Brexpiprazole

Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM), which means that the drug is a partial agonist at 5-HT1A and dopamine D2 receptors at relatively equal potency, an antagonist at 5-HT2A and an antagonist at noradrenaline alpha1B/2C receptors. A New Drug Application for brexpiprazole has been filed with the U.S. Food and Drug Administration (FDA) and the PDUFA date is in July 2015.

About Otsuka America Pharmaceutical, Inc.

Otsuka America Pharmaceutical, Inc. (OAPI) is an innovative, fast-growing healthcare company that commercializes Otsuka-discovered and in-licensed products in the U.S., with a strong focus on neuroscience, oncology, cardio-renal, and medical devices. For more information, visit http://www.otsuka-us.com. OAPI is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka Pharmaceutical is a leading firm in the challenging area of mental health and also has products and research programs for several under-addressed diseases including 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 Pharmaceutical and its affiliates employ approximately 30,000 people globally, and the company welcomes you to visit its global website at: http://www.otsuka.co.jp/en/index.php.

About Lundbeck

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are alcohol dependence, Alzheimer’s disease, bipolar disorder, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia and symptomatic neurogenic orthostatic hypotension (NOH). An estimated 700 million people worldwide are living with brain disease and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain disease – we call this Progress in Mind. Read more at http://www.lundbeck.com/global/about-us/progress-in-mind. In 2015, Lundbeck can celebrate its 100th anniversary. During the past century, millions of people have been treated with our therapies. It is complex and challenging to develop improved treatments for brain disease, but we keep our focus: There is still so much we need to achieve in the next 100 years to ensure a better life for people living with brain disease. Lundbeck has approximately 6,000 employees in 57 countries who are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China, Denmark and the United States and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 13.5 billion in 2014 (EUR 1.8 billion; USD 2.4 billion).

Lundbeck in the U.S. 

In the U.S., Lundbeck employs more than 800 people focused solely on accelerating therapies for brain diseases. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in hundreds of initiatives each year that support our patient communities. To learn more, visit us at http://www.lundbeck.com/us and connect with us on Twitter at @LundbeckUS.
Otsuka U.S. Contact Lundbeck U.S. Contact
Kimberly Whitefield
Corporate Communications 
Otsuka America Pharmaceutical, Inc. kimberly.whitefield@otsuka-us.com
+1 609 535 9259
Ashleigh Duchene
Lundbeck
aduc@lundbeck.com
+1 847 282 1164