Otsuka Pharmaceutical Co., Ltd.

December 25, 2012

Otsuka and Lundbeck initiate the regulatory process for aripiprazole (once-monthly) depot formulation in Europe

  • Aripiprazole depot formulation is the first partial dopamine agonist in development for maintenance treatment of schizophrenia as extended-release injectable suspension
  • New data presented at the 51st Annual Meeting of the American College of Neuro-psychopharmacology (ACNP) support efficacy of aripiprazole depot formulation, thus further supporting the data package for the European filing
  • It is estimated that that schizophrenia affects approximately 1% of the adult population in Europe and the U.S., and approximately 24 million people worldwide*1,2

(Tokyo, Japan and Copenhagen, Denmark, December 21, 2012) Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the European Medicines Agency's (EMA) acceptance of the submission of a marketing authorisation application (MAA) for the approval of aripiprazole depot formulation. The application of aripiprazole depot formulation is for the maintenance treatment of adult patients with schizophrenia.

"Our efforts to bring the aripiprazole depot formulation to market demonstrate our long-term commitment to discover, develop and champion treatments for the most challenging psychiatric diseases," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "If approved, more patients with schizophrenia will have access to the efficacy and safety profile of aripiprazole in a once-monthly formulation."

"Long-acting therapies are moving to the forefront of treatment for psychiatric disorders, and I am very excited that we now also have submitted this product in Europe," says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: "If approved, aripiprazole depot formulation will offer the clinical properties of oral aripiprazole, including its safety and efficacy profile, in a form that is suited to patients who may have difficulties consistently taking their medication."

Aripiprazole depot formulation is the first dopamine D2 partial agonist submitted in Europe as a once-monthly injection. If approved, it will be a new treatment option to address the need for relapse prevention in patients with schizophrenia, a chronic and debilitating disease.

Results from the first clinical trial of aripiprazole depot formulation were presented in four poster presentations at the 2012 American Psychiatric Association (APA) Annual Meeting in May 2012 and have subsequently been published in the Journal of Clinical Psychiatry (Kane et al J Clin Psych, 2012). In December 2012, data from the second pivotal trial were presented at the 51st Annual Meeting at the American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida.

On 11 November 2011, Otsuka and Lundbeck announced an alliance to collaborate on the development and commercialisation of up to five early and late stage compounds in development. The two companies will co-commercialise aripiprazole depot formulation in the U.S. and will collaborate on the development and commercialisation of aripiprazole depot formulation in other markets worldwide. Aripiprazole depot formulation remains under review by the U.S. Food and Drug Administration (FDA).

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or USD 3.0 billion). For more information, please visit