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Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder

Valby, Denmark and Tokyo, Japan, 28 July 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced Abilify Maintena® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults1.

Abilify Maintena is a once-monthly injectable formulation for intramuscular use created by Otsuka and has been co-developed and co-commercialized with Lundbeck. Based on phase III study data, Abilify Maintena delayed the time to recurrence of any mood episode in adult patients experiencing a manic episode at screening compared to placebo1.

"Bipolar I disorder is a recurrent chronic mental illness. Abilify Maintena provides healthcare professionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole," said Joseph Calabrese, MD, Director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, and Professor of Psychiatry at Case Western Reserve University School of Medicine. "Receiving Abilify Maintena each month as prescribed and administered by a HCP, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder; it is important to note that concomitant oral antipsychotic must be administered for 14 days after the first injection."

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis. Abilify Maintena is contraindicated with a known hypersensitivity reaction to aripiprazole.

About the Clinical Trial

The phase III clinical trial supporting regulatory approval demonstrated the efficacy and safety of Abilify Maintena in the maintenance monotherapy treatment of BP-I. The study included patients who were experiencing a manic episode at trial entry and met DSM-IV-TR criteria for bipolar I disorder. In addition, patients had a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent. The clinical trial was a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adults with BP-I aged 18 to 65 years, who were stabilized with Abilify Maintena prior to randomization1. The primary endpoint demonstrated Abilify Maintena significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo1. The trial demonstrated significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes1.

About Abilify Maintena (aripiprazole)

Abilify Maintena (aripiprazole) for extended-release injectable suspension is an atypical antipsychotic for intramuscular use. It was created by Otsuka in Japan and has been co-developed and co-commercialized by the alliance between Otsuka and Lundbeck. Abilify Maintena was approved in the U.S. in 2013 for the treatment of adults with schizophrenia1. Abilify Maintena is a sterile lyophilized powder that when reconstituted with sterile water for injection, forms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing of oral antipsychotic treatment). Subsequent doses of Abilify Maintena provide uninterrupted medication coverage for up to 30 days1. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for extended periods of time1,2.

The most commonly observed adverse reactions with Abilify Maintena in patients with schizophrenia (incidence of 5 percent or greater and aripiprazole incidence at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation1.

About Bipolar I Disorder

BP-I is a chronic mental illness with a 12-month and lifetime prevalence of 1.5% and 2.1%, respectively3,4. People with BP-I experience one or more episodes of mania, and may have episodes of both mania and depression3,5.

About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia.

Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion).

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical 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 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 leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS.

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.

REFERENCES:

  1. ABILIFY MAINTENA (aripiprazole) in US 2017 full prescribing information.
  2. RISPERDAL CONSTA (risperidone) 2017 prescribing information. Janssen. https://www.janssencns.com/shared/product/risperdalconsta/prescribing-information.pdf
  3. Bipolar Disorder. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Mental-Health-Conditions/Bipolar-Disorder. Accessed September 27, 2016.
  4. Epidemiology of DSM-5 bipolar I disorder: Results from the national epidemiologic survey on alcohol and related conditions - III. Blanco C, Compton WM, Saha TD et al. J Psychiatr Res 84 (2017) 310-317.

Source: H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd.

Posted: July 2017

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