Timely approval of Abilify Maintena boosts outlook for Otsuka and Lundbeck.
By Michael Haydock, Lead Analyst
4 March 2013
I am the Lead Analyst of the immunology and inflammation and infectious diseases and vaccines teams at Datamonitor Healt...
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On March 1, 2013, Otsuka and Lundbeck announced the FDA approval of a once-monthly intramuscular depot formulation of Abilify (aripiprazole) for the treatment of schizophrenia. Abilify Maintena is the first extended-release injectable suspension formulation of Abilify to gain regulatory approval, with US launch planned for March 18.
The FDA’s decision was based on a Phase III study of 403 patients with schizophrenia which showed that the monthly depot formulation significantly delayed the time to relapse compared to placebo. The study also met the secondary endpoint, with only 10% of patients receiving Abilify Maintena experiencing relapse compared to 40% on placebo. Improving relapse prevention is a key unmet need for the 2.2 million individuals estimated by Datamonitor to be affected by schizophrenia in the US in 2013.
Approval of Abilify Maintena is a strategic milestone for the partnership between Lundbeck and Otsuka, representing the first product from their joint CNS development program to enter the US psychiatry market. The imminent launch will be a geographical expansion for Lundbeck, which has historically focussed on European markets. Approval also comes at an opportune time; Lundbeck’s revenues went into decline after the US patent expiry of Lexapro (escitalopram oxalate) in March 2012, and with patent protection for the oral formulation of Abilify due to expire in the US in Q2 2015, Otsuka will be seeking to minimize the impact of generic erosion by encouraging physicians to switch their patients to the new formulation.
The new depot formulation will inherit a strong patient base from oral Abilify, which achieved global sales of $2.8bn in 2012. Nevertheless, Abilify is not the first antipsychotic to be launched as a once-monthly depot formulation. Johnson & Johnson’s Invega Sustenna (paliperidone) has been available since FDA approval in 2009 and will offer strong competition for new patients. However, Abilify possesses a superior tolerability profile, demonstrating decreased weight gain and reduced incidence of hyperlipidemia and hyperglycemia, which will help differentiate the product from its depot competitors.
Abilify Maintena’s US launch will take place at least 2 years ahead of launch of Alkermes’s depot formulation of aripiprazole lauroxil, which remains in Phase III development. Alkermes is awaiting data from a pivotal Phase III trial in September 2013 and intends to file for approval in 2014. Abilify Maintena’s earlier entrance will be a significant advantage, allowing Otsuka and Lundbeck to establish a firm foothold in the market.
Datamonitor expects Abilify Maintena to take over the position of market leader from Abilify and forecasts US sales in schizophrenic patients to reach $532m in 2021.