Otsuka and Lundbeck receive positive CHMP opinion for Abilify Maintena(r) in schizophrenia
- If approved by the European commission, Abilify Maintena would become the only dopamine D2 partial agonist in once-monthly injectable form for the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole
- Reducing the risk of relapse is an important consideration in the treatment of patients with schizophrenia. Clinical trials demonstrated that Abilify Maintena reduced the risk of relapse in adult patients with schizophrenia in comparison with placebo
- Approval of this new once-monthly formulation of aripiprazole in Europe will provide patients with schizophrenia with an effective and well tolerated alternative treatment option
Valby, Denmark and Tokyo, Japan, 20 September 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilised 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 US. It represents an alternative treatment option to address the 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 stabilised 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 stabilised with oral aripiprazole.
“Abilify Maintena has been available in the US 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 into the psychiatric community in Europe as well”, said Ole Chrintz, Senior Vice President, International Markets & Europe at Lundbeck. “Abilify Maintena represents an important treatment option for patients, their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia”.
“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, CEO & President, Otsuka Europe.
The efficacy of Abilify Maintena was demonstrated in two double-blind, randomised phase III trials over 38 and 52 weeks respectively. 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 superiority to a sub-therapeutic dose of aripiprazole once monthly1. The key secondary endpoint, time to relapse, supported the efficacy in maintenance treatment.
In the second efficacy trial, Abilify Maintena significantly delayed time to relapse compared to placebo (primary efficacy endpoint)2. In a key secondary endpoint, the percentage of subjects experiencing relapse was also significantly lower with Abilify Maintena compared to placebo at the end of the study.
The safety profile for Abilify Maintena was comparable to oral Abilify1.The most common side effects are weight gain, akathisia (restlessness), insomnia (difficulty in sleeping), injection site pain.
On 11 November 2011, Otsuka and Lundbeck announced the formation of an alliance to collaborate on the development and commercialisation of up to five early and late stage compounds in development. Abilify Maintena is expected to be the first approved and commercialised product in the EU from the global alliance between the two companies, focused on developing Central Nervous System (CNS) therapies worldwide.
Lundbeck will make a milestone payment to Otsuka of USD 75 million upon the European Commission’s final approval of Abilify Maintena.
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 life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of the adult population in the US and Europe, and approximately 24 million people worldwide3,4. In the US, there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders5,6. 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 symptoms7.
Schizophrenia places a significant burden on society and is according to the WHO the 8th leading cause of DALYs (lost healthy years) worldwide between the age of 15-448 and is also regarded among the most financially costly illnesses. With 50% of patients not receiving appropriate care and 80% of patients relapsing within the first 5 year9, 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 and they include poor insight about their illness, side effects from their current treatment, complicated medication regimens or lack of support from their family10.
About Abilify Maintena (aripiprazole)
Abilify Maintena powder and solvent for prolonged-release suspension for injection, 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 stabilised 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.
Lundbeck contacts
| Investors: | Media: |
| Palle Holm Olesen | Mads Kronborg |
| Chief Specialist, Head of Investor Relations | Media Relations Manager |
| palo@lundbeck.com | mavk@lundbeck.com |
+45 36 43 24 26 | +45 36 43 30 00 |
| Jens Høyer | |
| Investor Relations Officer | |
| jshr@lundbeck.com | |
| +45 36 43 33 86 | |
Otsuka Pharmaceutical Co., Ltd. Contacts
| Media: | Media: |
| EUROPE | JAPAN/ASIA |
| Alison Ross | Jeffrey Gilbert |
| Otsuka Pharmaceutical Europe Ltd. | Otsuka Pharmaceutical Co., Ltd. |
| aross@otsuka-europe.com | gilbert.jeffrey@otsuka.co.jp |
| +44 7768 337128 | +81 3 6361 7379, +81 80 8728 6039 (cell) |
| NORTH AMERICA | |
| Rose Weldon | |
| Otsuka America Pharmaceutical, Inc. | |
| rose.weldon@otsuka-us.com | |
| +1 609 524 6879, +1 215 801 7644 (cell) | |
| Investors: | |
| Takuma Kimura Investor Relations Department Otsuka Holdings Co., Ltd. kimurata@otsuka.jp +81 3 6361 7411 |
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at the forefront of research within neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living with brain diseases. Our key areas of focus are alcohol dependence, Alzheimer’s disease, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia and stroke.
Our 5,800 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the quality of life of people living with brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more 100 countries. We have research centers in China, Denmark and the United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK15 billion in 2012 (EUR 2 billion; USD 2.6 billion).
Lundbeck’s shares are listed on the stock exchange in Copenhagen under the symbol ”LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol ”HLUYY”. For additional information, we encourage you to visit our corporate site www.lundbeck.com.
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
References
1) Fleischhacker, et al. poster APA 2013
2) Kane, JM et al. J Clin Psych 2012:73(6):617-624
3) National Institute of Mental Health (NIMH). Health Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml Accessed July 19, 2012.
4) World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at http://www.who.int/mental_health/management/schizophrenia/en/ Accessed July 16. 2012
5) 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.
6) Regier, Darrel et al. The de Facto US Mental and Addictive Disorder Service System. Arch Gen Psychiatry. 1993; 50: 85-94
7) World Health Organization (2001) The World Health Report, page 27, accessed at http://www.who.int/whr/2001/en/whr01_en.pdf
8) World Health Organization (2013) ‘Schizophrenia’, accessed at http://www.who.int/mental_health/management/schizophrenia/en/
9) Robinson D, et al. Arch Gen Psychiatry. 1999;56(3):241-247
10) 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
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.
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