Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Existing Collaboration with Lundbeck

TOKYO & COPENHAGEN, Denmark --(Business Wire)--

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today outlined co-promotion plans and summarized the overall progress in their global alliance at a session in Japan with representatives from domestic and international media organizations.

The companies announced that ABILIFY MAINTENA™ (aripiprazole), an extended-release (once-monthly) injectable suspension for the treatment of schizophrenia will start becoming available in the U.S. market on March 18. ABILFY MAINTENA was approved by the U.S. Food and Drug Administration (FDA) on February 28 for the treatment of schizophrenia.

ABILIFY MAINTENA and ABILIFY^® contain the molecule aripiprazole, which is a partial agonist at the D2 dopamine receptor and which offers a unique mechanism of action for the treatment of schizophrenia. ABILIFY MAINTENA has been shown in clinical studies to reduce relapses in schizophrenia in comparison to placebo and will offer the efficacy and safety profile of the oral formulations of ABILIFY in a once-monthly formulation.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. emphasized that "the MAINTENA launch will further strengthen the ABILIFY brand's already-prominent position in the U.S. market and bodes well for the two companies' ongoing collaborations."

Commenting on the first regulatory approval for the alliance, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance. The launch of ABILIFY MAINTENA also represents Lundbeck's first entry into the U.S. psychiatry market, expanding our central nervous system focus strategically in the U.S."

The companies also announced an agreement to expand their existing collaboration to include promotion of oral ABILIFYin 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly promote ABILIFY in Denmark, Finland, Germany, Italy, Spain, Sweden and the United Kingdom. Lundbeck will promote ABILIFY in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania.

The agreement provides Lundbeck with the rights to promote all formulations of ABILIFY that are currently being marketed, sold and distributed by Otsuka in the European Union including the swallowable tablet, oral solution, orally-disintegrating tablet and the IM rapid injectable. Lundbeck will promote ABILIFY Tablets in first position to target physicians.

Summary of Overall Progress in the Global Alliance Between Otsuka and Lundbeck

While some other companies have exited the central nervous system therapy area, Otsuka and Lundbeck are investing to develop potential future drugs to help patients, such as brexpiprazole, which is currently in phase III clinical trials for multiple psychiatric disorders, and three other compounds yet to be determined. An agreement to work in this under-served therapy area was signed between the two companies in November, 2011. A successful first 17 months for the alliance includes the following developments:

FDA approval of ABILIFY MAINTENA on February 28, 2013.
Marketing Authorization Application (MAA) for ABILIFY MAINTENA submitted in Europe in December, 2012.
Expansion of the alliance by the signin of an agreement for promotion of ABILIFY products in Europe.
Phase-III studies initiated with brexpiprazole.
Two phase-III studies with ABILIFY MAINTENA initiated.
Results from phase-III trials with ABILIFY MAINTENA presented in May, 2012 at the American Psychiatric Association (APA) 2012 Annual Meeting.

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 (News - Alert)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 Europe, and approximately 24 million people worldwide.^1,2

Relapse of schizophrenia can occur when a patient no longer responds to antipsychotic medication or when patients stop taking their medication. There are many reasons patients stop taking their medication and they include: poor insight about their illness, side effects from their current treatment, complicated medication regimens or lack of support from their family.

About ABILIFY MAINTENA and ABILIFY

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.

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.^3,4

The ABILIFY MAINTENA launch will further leverage the success of ABILIFY. As a result of a significant, multi-year development effort, 14 New Drug Applications (NDA) and Supplemental New Drug Applications (sNDA) have been approved in the U.S. market for new uses and formulations supporting ABILIFY since the product was introduced in 2002. Over this period, ABILIFY has been used by more than 6 million patients. In 2012, ABILIFY was ranked number one among antipsychotic drugs in a Harris Poll Physician Pulse (News - Alert) survey that measured five key attributes to gauge U.S. physicians' trust in leading antipsychotic medications⁵. In the fourth quarter of 2012 ABILIFY became the #1 selling pharmaceutical product in the U.S⁶.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, 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. Otsuka is committed to being a corporation that creates global value, adhering to the 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 the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 25 countries and regions around the world, with consolidated sales of approximately USD 14.7 billion for fiscal year 2011 (4/1/2011-3/31/2012.) We welcome you to visit our 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.

We have employees 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.

1. National Institute of Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012.
2. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at http://www.who.int/mental_health/management/schizophrenia/en/. Accessed July 16, 2012.
3. Patel MX, David AS. "Why aren't depot antipsychotics prescribed more often and what can be done about it " Adv Psychiatr Treat, 2005; 11: 203-213.
4. Kane, JM et al. "Guidelines for depot antipsychotic treatment in schizophrenia." Eur.Neuropsychopharmacol, 1998; 8(1): 55-66.
5. Harris Poll 2012 Physician Pulse Ranking of U.S. Physician Trust in Anti-Psychotics
6. IMS