Otsuka Pharmaceutical Co Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have outlined co-promotion plans and summarised the overall progress in their global alliance at a session in Japan with representatives from domestic and international media organisations.
The companies announced an agreement to expand their existing collaboration to include promotion of Abilify in 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the UK. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania.
The agreement provides Lundbeck with the rights to promote all formulations of Abilify that are currently being marketed, sold and distributed by Otsuka in the European Union including the swallowable tablet, oral solution, orally-disintegrated tablet and the intramuscular rapid injectable.
Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co Ltd. emphasised that ‘the agreement will further strengthen the Abilify brand in Europe and also position Otsuka and Lundbeck to successfully develop and launch up to five more new products there.’
The companies also announced that Abilify Maintena™ (aripiprazole), an extended-release (once-monthly) injectable suspension for the treatment of schizophrenia will start becoming available in the US. market on March 18. Abilify Maintena was approved by the US Food and Drug Administration (FDA) on February 28 for the treatment of schizophrenia.
Commenting on the first regulatory approval for the alliance, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, “Abilify Maintena represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance. The launch of Abilify Maintena also represents Lundbeck’s first entry into the U.S. psychiatry market, expanding our central nervous system focus strategically in the US.”
Specific financial terms of the agreement remain undisclosed.
Abilify Maintena and Abilify contain the molecule aripiprazole, which is a partial agonist at the D2 dopamine receptor and which offers a unique mechanism of action for the treatment of schizophrenia. Abilify Maintena has been shown in clinical studies to reduce relapses in schizophrenia in comparison to placebo and will offer the efficacy and safety profile of the oral formulations of Abilify in a once-monthly formulation.
Summary of overall progress in the global alliance between Otsuka and Lundbeck
While some other companies have exited the central nervous system therapy area, Otsuka and Lundbeck are investing to develop potential future drugs to help patients, such as brexpiprazole, which is currently in phase III clinical trials for multiple psychiatric disorders, and three other compounds yet to be determined. An agreement to work in this under-served therapy area was signed between the two companies in November 2011. A successful first 17 months for the alliance includes the following developments:
- FDA approval of Abilify Maintena on February 28, 2013.
- Marketing Authorization Application (MAA) for Abilify Maintena submitted in Europe in December 2012.
- Expansion of the alliance by the signing of an agreement for promotion of Abilify products in Europe.
- Phase-III studies initiated with brexpiprazole.
- Two phase-III studies with Abilify Maintena initiated.
- Results from phase-III trials with Abilify Maintena presented in May 2012 at the American Psychiatric Association (APA) 2012 Annual Meeting.