Otsuka Pharmaceutical Co., Ltd. Release: Pre-Filled Dual-Chamber Syringe For Abilify Maintena (Aripiprazole) Prolonged-Release Suspension For Injection, Used In The Treatment Of Schizophrenia, Receives Positive CHMP Opinion (Approval In EU)

TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) on 26^th March issued a positive opinion (approval in EU) for the new pre-filled dual chamber syringe kit to administer Abilify Maintena^® for the maintenance treatment of schizophrenia.

The dual chamber pre-filled syringe is a new addition to the Abilify Maintena offering. Reconstitution occurs within the pre-filled dual chamber syringe, in a single step, which allows for easier handling. This product enhancement offers another option to simplify delivery of care to patients with schizophrenia and provides healthcare professionals with an easier-to-use option.

CHMP positive opinion (approval in EU) of the dual chamber kit follows the recent approval of the deltoid muscle as a new injection site for Abilify Maintena,¹ the latter approval providing patients with a wider range of treatment options.

These new additions to Abilify Maintena are expected to be available for use later in the year.

About Abilify Maintena (aripiprazole)

Abilify Maintena is the first commercialised product in Europe from the global alliance between Otsuka and H. Lundbeck A/S (Lundbeck). Abilify Maintena is the only long-acting injectable (LAI) antipsychotic that exerts partial agonist activity at the D₂ dopamine receptor. It provides physicians with an alternative treatment option, with a tolerability profile comparable to the well-established oral Abilify^® (aripiprazole), to address the ongoing need to protect patients with schizophrenia from relapse.

Abilify Maintena is a once-monthly formulation of aripiprazole in a sterile lyophilised powder that is reconstituted with sterile water. After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.¹

In Europe, Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. Abilify Maintena is available in a number of European countries and is progressing through the various healthcare authorities that provide access to patients. Abilify Maintena was approved by the US FDA in 2013 for the treatment of schizophrenia and includes the treatment of acutely relapsed adult patients with schizophrenia. It subsequently received marketing authorisations for the maintenance treatment of schizophrenia in stabilised adult patients in Canada, for the maintenance of clinical improvement in the treatment of schizophrenia in Australia, and for the maintenance treatment of schizophrenia in stabilised adult patients in Japan.

About the Otsuka and Lundbeck Global Alliance

Otsuka and Lundbeck established a global alliance in November 2011 to bring to bear their considerable experience and resources in the CNS area to introduce next-generation treatments for conditions such as schizophrenia, depression, Alzheimer’s disease and alcohol dependency.

About Otsuka

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 programmes 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 Europe Ltd. (OPEL) was established in 1979. Reflecting Otsuka’s ethos of ‘super people not super computers’, Otsuka's 550 European employees focus their passion and energy into ensuring that patients in Europe have access to Otsuka’s innovative products and medical devices in our key therapy areas of CNS, endocrinology, nephrology, gastroenterology and oncology. Clinical development, commercialisation and sales and marketing operations in France, Germany, Italy, the Nordic region, Spain, Switzerland and the UK are all supported by Otsuka's European regional office, based in west London.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group employs approximately 44,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were over €10 billion or $14 billion for fiscal year 2013 (April 1, 2013 to March 31, 2014).

OPEL welcomes you to visit its European regional website at www.otsuka-europe.com

For more information on Otsuka Pharmaceutical Co., Ltd. please visit its global website at
https://www.otsuka.co.jp/en/

REFERENCES:

1. European Medicines Agency (EMA). Abilify Maintena Summary of Product Characteristics. [Accessed March 2015]. Available from: http://www.ema.europa.eu/ema/.