Lundbeck and Otsuka’s once-monthly schizophrenia treatment Abilify Maintena has been launched onto the market in Europe, with Denmark becoming the first country to fully reimburse the drug.
Abilify Maintena (aripiprazole) – given as a depot injection – is one of key products Lundbeck needs to replace sales of Cipralex (escitalopram) and the immediate-release oral formulation of Abilify that have been lost to generic competition.
Lundbeck said today that Abilify Maintena will be on the market in 10 countries by the end of year. The new product has also been approved in the US and Canada, where it is licensed by originator Otsuka to Bristol-Myers Squibb (BMS).
Abilify Maintena is being launched onto the market at a time of significant change in the schizophrenia therapy market, with a string of blockbuster atypical antipsychotics – such as Eli Lilly’s Zyprexa (olanzapine) and AstraZeneca’s Seroquel (quetiapine) – now available generically.
As a result Lundbeck is highlighting Abilify Maintena’s ability to protect schizophrenia patients who have already been stabilised with oral aripiprazole from breakthrough psychotic episodes.
It already faces competition from other depot formulations, including Johnson & Johnson’s Risperdal Consta (risperidone) and fast-growing Xeplion (paliperidone) as well as Lilly’s Zypadhera (olanzapine).
The challenge for the company is to convince doctors to prescribe the drug not only for patients with long-standing symptoms that may result from non-compliance with oral drugs, but also those who are newly-diagnosed with the illness.
“Patients early in the course of their disease may have the most to gain from a long-acting treatment,” points out Ole Chrintz, senior vice president of international markets and Europe at Lundbeck.
Once-monthly treatment for these patients can reduce their risk of relapse over the long term and can help them maintain personal and social functioning, he adds.
Standing in Abiliy Maintena’s favour is the large body of patients who are already being treated with oral aripiprazole, but how effective Lundbeck and Otsuka will be in pushing take-up remains to be seen. Analysts’ estimates for peak sales vary widely, from around $500m to more than $2bn.
Meanwhile, the entire schizophrenia sector could be shaken up by the arrival of new drugs that tackle the negative symptoms of the illness. Aripiprazole and other atypical antipsychotics are pretty effective at treating positive symptoms such as delusions and hallucinations, but less so at negative symptoms such as apathy and social withdrawal.
Prospects for drugs that tackle the latter remain up in the air, however; Roche’s bitopertin was leading the field but generated poor results in two phase III trials reported earlier this year, while Lilly dropped another potential therapy – pomaglumetad methionil in 2012.