12 Mar 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Japanese company Otsuka Pharmaceutical and H Lundbeck, Denmark-based company, have outlined co-promotion plans and summarized the overall progress in their global alliance at a session in Japan with representatives from domestic and international media organizations.
The companies announced that Abilify Maintena (aripiprazole), an extended-release (once-monthly) injectable suspension for the treatment of schizophrenia, will be made available in the US market from March 18, 2013. The drug was approved by the US Food and Drug Administration (FDA) on February 28 for the treatment of schizophrenia.
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.
Mr Taro Iwamoto, president and representative director of Otsuka Pharmaceutical emphasized that "the Maintena launch will further strengthen the Abilify brand's already-prominent position in the US market and bodes well for the two companies' ongoing collaborations".
Commenting on the first regulatory approval for the alliance, Mr 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 US psychiatry market, expanding our central nervous system focus strategically in the US."
The companies also announced an agreement to expand their existing collaboration to include promotion of oral 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-disintegrating tablet and the IM rapid injectable.