-- now try to flog abilify in this context….. Alkermes ($ALKS) picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia. Dubbed Aristada, Alkermes' drug is a monthly or every-6-weeks treatment that, once injected into the body, slowly transforms into aripiprazole, the active ingredient in Abilify. In a 12-week Phase III trial, Aristada led to a statistically significant improvement in schizophrenia symptoms compared with placebo. Alkermes said it's ready to launch the new drug "immediately," hoping to carve out a spot in a crowded, competitive market. In April, the FDA approved four generics of Abilify, including one from Teva Pharmaceutical ($TEVA), imperiling the value of a drug that brought in $5.5 billion for Otsuka last year. The schizophrenia market is also flooded with generics of Risperdal, Seroquel and Zyprexa, plus a pair of newly approved branded drugs: Otsuka and Lundbeck's Rexulti, cleared in July, and Allergan ($AGN) and Gedeon Richter's long-delayed Vraylar, which won U.S. approval last month. But Alkermes believes Aristada's lengthy half-life will help it stand out among so many treatments, including other monthly options. The drug is the only schizophrenia therapy approved for both every-four-weeks and every-6-weeks dosing, according to the company, and management believes there's enough unmet need to create demand.
