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Otsuka Pharmaceutical Co., Ltd. and Lundbeck Inc. (LUN.CO) Receive Positive CHMP Opinion in Europe for Abilify Maintena™, a Once-Monthly Injectable for Schizophrenia


9/20/2013 6:37:15 AM

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Otsuka and Lundbeck Receive Positive CHMP Opinion in Europe for Abilify MaintenaTM, a Once-Monthly Injectable for Schizophrenia

TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

The pharmacological properties of aripiprazole are mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors. Abilify Maintena is a once-monthly injectable form of aripiprazole that has already received regulatory approval in the U.S. It represents an alternative treatment option to address the ongoing need to reduce the risk of relapse (relative to placebo) in patients with schizophrenia.

The benefits with Abilify Maintena are its ability to reduce the proportion of stabilized patients experiencing relapse in long-term use and its properties to act as long-acting agent, allowing a monthly administration instead of a daily oral intake of aripiprazole. Patients are previously stabilized with oral aripiprazole.

“I am delighted that we now have a positive opinion for Abilify Maintena from the CHMP and if approved will be able to provide European patients with a long-term maintenance option for schizophrenia,” said Ole Vahlgren, Chief Executive Officer & President, Otsuka Europe.

“Abilify Maintena has now been available in the U.S. for some six months with encouraging feedback from patients and physicians, and we now look forward to launching this important treatment alternative together with our partner Otsuka into the psychiatric community in Europe as well,” said Ole Chrintz, Senior Vice President, International Markets & Europe, Lundbeck. He continued, “Abilify Maintena represents an important treatment option for patients as well as their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia.”

The efficacy of Abilify Maintena was demonstrated in two double-blind, randomized phase III trials over 38 and 52 weeks.

In the primary pivotal trial analysis of the primary efficacy endpoint, the proportion of patients experiencing impending relapse by the end of week 26, demonstrated non-inferiority of Abilify Maintena to oral aripiprazole and superior to a sub-therapeutic dose of aripiprazole once monthly (Fleischhacker et al, poster, APA 2013). The key secondary endpoint, time to relapse, supported the efficacy in maintenance treatment.

In the second pivotal efficacy trial, Abilify Maintena significantly delayed time to relapse compared with placebo (primary efficacy endpoint).1 In a key secondary endpoint, the percentage of subjects experiencing relapse was also significantly lower with Abilify Maintena compared with placebo at the end of the study.

The safety profile for Abilify Maintena was comparable to oral Abilify. The most frequently observed adverse drug reactions (ADRs) reported in = 5 % of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection site pain (5.1%).1

On 11 November 2011, Otsuka and Lundbeck announced the formation of an alliance to collaborate on the development and commercialization of up to five early- and late-stage compounds in development. Abilify Maintena is expected to be the first commercialized product in the EU from the global alliance between the two companies focused on developing Central Nervous System (CNS) therapies worldwide.

About Schizophrenia and Disease Relapse

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 lifelong treatment to mitigate symptoms.

It has been estimated that schizophrenia affects approximately 1 percent of the adult population in the U.S. and Europe, and approximately 24 million people worldwide.2,3 In the U.S., there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.4,5 While there is no cure for the disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk of disease relapse, which can cause the re-emergence or worsening of psychotic symptoms.6

Schizophrenia places a significant burden on society and is according to the World Health Organization (WHO), the 8th leading cause of DALYs (lost healthy years) worldwide between the age of 15-447 and is also regarded among the most financially costly illnesses. With 50 percent of patients not receiving appropriate care and 80 percent of patients relapsing within the first 5 years,8 there is a significant unmet need to be addressed in schizophrenia.

Relapse of schizophrenia can occur when a patient no longer responds to antipsychotic medication or stops taking their medication. There are many reasons patients stop taking their medication, including poor patient insight about their illness, side effects from his or her current treatment, complicated medication regimens or lack of support from family.9

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 maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

After an initial injection of Abilify Maintena along with a transitional 14-day dosing of oral aripiprazole treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time.

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 also has research programs on 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 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 USD13 billion or €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 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.

REFERENCES:

1. Kane, JM et al. “Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.” J Clin Psychiatry 2012;73(5):617-62

2. National Institute of Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012

3. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at: http://www.who.int/mental_health/management/schizophrenia/en/. Accessed July 16. 2012.

4. Topics-Statistics: Schizophrenia. 2010. Available at http://wwwapps.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml#RegierServiceSystem. Accessed July 18, 2012.

5. Regier, Darrel et al. The de Facto US Mental and Addictive Disorder Service System. Arch Gen Psychiatry. 1993; 50: 85-94

6. World Health Organisation (2001) The World Health Report, page 27, accessed at http://www.who.int/whr/2001/en/whr01_en.pdf

7. World Health Organisation (2013) ‘Schizophrenia’, accessed at http://www.who.int/mental_health/management/schizophrenia/en/.

8. Robinson D, et al. Arch Gen Psychiatry. 1999;56(3):241-247

9. Baloush-Kleinman V et al. Schizophr Res (2011), Beck EM et al. Schizophr Res 2011, Birnbaum M, Sharif Z. Patient Prefer Adherence 2008, Misdrahi D et al. Nord J Psychiatry 2012

Contacts

Otsuka Pharmaceutical Co., Ltd. Contacts

Media:

EUROPE

Otsuka Pharmaceutical Europe Ltd.

Alison Ross, +44 7768 337128

aross@otsuka-europe.com

or

JAPAN/ASIA

Otsuka Pharmaceutical Co., Ltd.

Jeffrey Gilbert, +81 3 6361 7379, +81 80 8728 6039 (cell)

gilbert.jeffrey@otsuka.co.jp

or

NORTH AMERICA

Otsuka America Pharmaceutical, Inc.

Rose Weldon, +1-609-524-6879, +1-215-801-7644 (cell)

rose.weldon@otsuka-us.com

or

H. Lundbeck A/S Contacts

Media:

U.S.

Lundbeck

Ashleigh Duchene, +1-847-282-1164

aduc@lundbeck.com

or

EUROPE

Lundbeck

Mads Kronborg, +45 36 43 28 51

mavk@lundbeck.com

or

Investors:

Lundbeck

Palle Holm Olesen, +45 36 43 24 26

Chief Specialist, Investor Relations

palo@lundbeck.com

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