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Depot Abilify approval in US buoys Lundbeck and Otsuka

FDA licences the once-monthly version of Lundbeck's blockbuster schizophrenia drug

Lundbeck HQ

Lundbeck chalked up its second piece of welcome product news this week after the US FDA approved a once-monthly version of its blockbuster schizophrenia treatment Abilify.

Abilify Maintena (aripiprazole) – for which Lundbeck has partnered with Japanese pharma company Otsuka in the US - becomes the first depot formulation of a dopamine D2 partial agonist to be cleared by the FDA for preventing schizophrenia relapses and is due to be launched on March, 18.

The go-ahead comes shortly after Lundbeck won EU approval for its alcohol addiction therapy Selincro (nalmefene) and at a time when the Danish drugmaker needs new products to help it cope with the loss of patent protection for its antidepressant Lexapro/Cipralex (escitalopram).

Abilify Maintena was turned down by the FDA last year after an inspection revealed quality control problems at a third-party supplier of sterile water used in the product, but Lundbeck and Otsuka swapped suppliers and resubmitted their application.

It will compete in the US market place with Johnson & Johnson's once-monthly Invega Sustenna (paliperidone) product, which has been available since 2009 and racked up almost $800m in sales for J&J last year. Meanwhile, phase III testing of a three-month depot of paliperidone, partnered with Alkermes, got underway last June. 

The new product will help protect the $2.8bn Abilify franchise when the current once-daily formulation loses patent protection in the US in April 2015, and is the first commercial product from a central nervous system (CNS) alliance set up by Lundbeck and Otsuka in 2011. 

The agreement covers up to five early and late stage compounds in development, including OPC-34712, a novel compound in phase III testing for schizophrenia and depression.

Once-daily Abilify was formerly sold in the US by Bristol-Myers Squibb, but Otsuka bought back overall rights to the drug last November after sales started to slip on competition from generic versions of other schizophrenia drugs. BMS is still involved in manufacturing the drug.

"The launch of Abilify Maintena … represents Lundbeck's first entry into the US psychiatry market, expanding our central nervous system focus strategically in the US," commented the company's chief executive Ulf Wiinberg.

1st March 2013

From: Sales

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