Of the seven blockbusters due to come off patent in 2015, the current biggest seller is Abilify. Otsuka’s antipsychotic, far and away the company’s most lucrative product, raked in $5.2bn worldwide in 2011 and the company will feel its loss keenly. Otsuka’s long-acting formulation, Abilify Depot, will mitigate this loss to a degree, but only if it is approved by the FDA next month.
The approval is even more crucial to the drug’s licensee, Lundbeck. The Danish group paid $200m up front for worldwide co-marketing rights, and needs the FDA to wave Abilify Depot through to help validate its strategy of focusing on CNS disorders. The FDA rejected an approval application in July, meaning that the partners have already lost eight months of market time. With competition in the form of Alkermes’ ALKS 9070 approaching fast, another delay to Abilify Depot would be a bad blow.
|% of market cap||5%||14%|
|Date||February 28, 2013|
Known generically as aripiprazole, Abilify is an atypical antipsychotic and the best-selling schizophrenia medication. A depot formulation is an exercise in lifecycle management, as well as being intended to increase compliance in a notoriously difficult population.
While it is some way behind Abilify itself, the once-monthly formulation is one of the standout products of the class of 2013. Of the drugs expected to be launched this year, it will have the eighth greatest sales in 2018, EvaluatePharma’s consensus data show (Which of 2013's launches will become blockbusters? January 23, 2013). Its sales in five years’ time will be around $994m, but with its patent holding fast until 2024 they could increase still further, making the drug a bona fide blockbuster.
A previous FDA rejection is rarely a good omen, but in this case it might not be too much of a problem. The complete response letter the depot formulation received from in July was prompted by problems with sterile water used for making the drug, supplied by a third party. At the time, JP Morgan analysts were confident that the problems would be easily solved.
Otsuka and Lundbeck will be cleaving to this belief. The Tom to Abilify Depot’s Jerry – or, less optimistically, the tortoise to its hare – is Alkermes’s ALKS 9070. This once-monthly prodrug of aripiprazole is under investigation in a 700-patient phase III trial set to report this summer, and is expected to reach market next year. With that kind of timeframe, every day counts for Otsuka and Lundbeck.