Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.
Otsuka is facing plenty of bleeding, now that its blockbuster antipsychotic Abilify has generic competition. But the company is working hard to soften the blow, and a brand-new FDA approval for a long-acting antipsychotic could help.
Shares in India's Torrent Pharmaceuticals jumped more than 4% on Wednesday after it won U.S. FDA approval for one of the first generic versions of Abilify, an antipsychotic from Japan's Otsuka Pharmaceuticals and Bristol-Myers Squibb for treating schizophrenia and bipolar disorder.
Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.
Bristol-Myers Squibb was staring down the end of a barrel at the beginning of this year, bracing for a sales hit as its blockbuster antipsychotic Abilify nears patent expiration. But in an about-face, the drugmaker is celebrating first-quarter earnings that beat the Street's forecasts thanks to promising numbers for some of its newer meds.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Otsuka's patent cliff is coming, with the expiration date on best-seller Abilify's IP shield just around the corner. But now, the Japanese pharma has signed a $3.5 billion agreement to pick up Avanir Pharmaceuticals that could help soften the blow.
Did Bristol-Myers Squibb offer kickbacks and push Abilify for off-label uses? Some former sales reps-turned-whistleblowers claim it did. And given the fact that Bristol-Myers already paid $515 million to settle some off-label marketing claims related to Abilify, they say, the company violated its "we'll behave" promises to the feds.
Alkermes has taken another step toward the market with its long-acting version of the schizophrenia drug Abilify, filing for an approval with the FDA as it lays the foundation for a hoped-for launch in 2015.
Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year.