Otsuka Holdings Co. and H. Lundbeck A/S won approval from U.S. regulators to market a new formulation of the mood-stabilizing drug Abilify as a once-monthly injection to treat schizophrenia.
The Food and Drug Administration cleared Abilify Maintena, a freeze-dried version of Abilify reconstituted with water to allow for a long-acting effect, the companies said today in a statement. Abilify currently is used daily.
The patent that protects the daily form of Abilify from generic competition expires in 2015 in the U.S., where it’s marketed by Bristol-Myers Squibb Co. The treatment generated $2.8 billion in 2012 sales for Bristol-Myers, making it the company’s best seller. Otsuka, the Tokyo-based developer of Abilify, created a partnership with Copenhagen-based Lundbeck for the longer-lasting dose.
Otsuka rose 1.4 percent to 3,010 yen in Tokyo, the highest price since the company’s initial public offering in December 2010. Lundbeck advanced 3.2 percent, the biggest gain since Nov. 7, to 99.95 kroner in Copenhagen.
In a 52-week study, once-monthly Abilify significantly delayed the time to relapse compared with a placebo, Otsuka and Lundbeck said in a statement. The FDA had rejected the companies’ drug application last year after an inspection spotted deficiencies at a sterile water supplier.
Johnson & Johnson has been selling a once-monthly schizophrenia drug called Invega Sustenna since it was approved by the FDA in 2009. Dublin-based Alkermes Plc is developing a similar drug that once in the body converts to the active ingredient in Abilify, aripiprazole.
J&J, based in New Brunswick, New Jersey, began in June a final-phase trial on a three-month formulation of Invega Sustenna using Alkermes’ technology. Alkermes has said it expects final-phase trial results on its drug aripiprazole lauroxil by the end of 2013
Invega Sustenna generated $796 million in sales last year for J&J, according to data compiled by Bloomberg.