FDA pins approval on once-monthly version of blockbuster Abilify

U.S. regulators handed Otsuka Pharmaceutical and Lundbeck some good news today, stamping an approval on the two drugmakers' once-monthly version of the big-selling schizophrenia drug Abilify.

To be sold under the name Abilify Maintena, the drug is the first once-monthly version of aripiprazole to win FDA approval. Otsuka and Lundbeck plan to jointly market the long-acting antipsychotic in the U.S., with availability of the injected drug expected on March 18. The companies will hit the market as Alkermes ($ALKS) continues Phase III development of a rival therapy known as aripiprazole lauroxil.

Abilify maker Otsuka and partner Bristol-Myers Squibb ($BMY) surpassed $5 billion in global sales of the oral version of the antipsychotic last year, and the companies face loss of patent exclusivity in 2015. While the new approval could ease the pain of this patent loss for Otsuka, Bristol has no stake in the once-monthly version.

With this approval, Danish drugmaker Lundbeck is having a banner week on the regulatory front. European authorities green-lighted the company's Selincro, a new drug against alcohol dependence, this week. And CEO Ulf Wiinberg is seeing his plans to usher in new products from his company's late-stage R&D pipeline materialize as the group seeks to move past big declines in sales of Lexapro because of generic drug competition.

Japan-based Otsuka, whose fortunes have relied heavily on Abilify sales for years, tied up with Lundbeck in November 2011 to advance the once-monthly aripiprazole and several other CNS candidates. After addressing the FDA's concerns about a third-party supplier of germ-free water for the product last year, the partners now have their first approval from their major global partnership.

The companies showed in late-stage trials that the long-acting version of Abilify reduced time to relapse compared with placebo, and it cut down relapse rates in patients with schizophrenia. Schizophrenia, which causes paranoia and delusions and other symptoms, afflicts 2.4 million U.S. adults, the companies said.

"As a strong believer in long-acting therapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can help reduce the risk of relapse and manage symptoms in patients," stated study investigator Dr. John Kane, chairman of psychiatry at the Zucker Hillside Hospital.

Alkermes expects to report results from its Phase III program of a different formulation of long-acting aripiprazole by the end of 2013, and the Dublin-based biopharma has high hopes that the product could become its best seller yet. The company provides the formulation technology for Johnson & Johnson's ($JNJ) long-acting antipsychotic drugs Risperdal Consta and Invega Sustenna.

Yet Alkermes owns full rights to aripiprazole lauroxil, which CEO Richard Pops has said could be a blockbuster product and a key to elevating the company to the next level of elite biotechs. Otsuka and Lundbeck's marketing efforts for Abilify Maintena could aid Alkermes in getting docs on board with long-acting antipsychotics, which account for shy of 10% of the more than $20 billion global market for a big class of atypical drugs.

On hearing of the news from Otsuka and Lundbeck on Thursday, Pops saluted the approval on Twitter as "good news for patients, physicians and families affected by schizophrenia."

- here's the release

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