Otsuka's antipsychotic franchise is facing more bad news, as Alkermes scored FDA approval for a long-acting injectable version of Abilify as it vies for a bigger spot in an increasingly crowded antipsychotic market.
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.
Pennsylvania-based Recro Pharma has picked up a new plant and jumped into the contract manufacturing business, while Irish drugmaker Alkermes is now one plant shorter and out of the CMO biz.
Alkermes unveiled more positive data for a schizophrenia drug the company believes can treat the disease without spurring weight gain, beating a path to late-stage development.
Alkermes is selling off a manufacturing plant in a deal worth up to $170 million, cashing out of some royalty streams to better invest in its late-stage pipeline of new therapies.
The decision by Irish drugmaker Alkermes to narrow its focus and sell a manufacturing plant is providing a chance for Pennsylvania-based Recro Pharma to expand its pain drug position and jump into the the contract manufacturing space to pick up some extra cash.
Alkermes has pulled the plug on an abuse-deterrent pain medication after it came up short in early testing, pivoting its focus to some preclinical analgesics.
Alkermes said the safety profile of its clinical-stage multiple sclerosis drug compares favorably to that of Biogen Idec's Tecfidera, citing the candidate's Phase I trial results on 104 patients.
Alkermes says its researchers nailed down the efficacy and safety data it needed from an early-stage study of ALKS 8700, its new-and-improved rival to the blockbuster multiple sclerosis drug Tecfidera from Biogen Idec. And now the transatlantic biotech plans to shift its drug straight into a pivotal study in search of a relatively swift approval.
When Alkermes set out to develop ALKS 3831 for schizophrenia, it took a well-known antipsychotic--olanzapine--and combined it with a mu-opioid antagonist called samidorphan with an eye to controlling the disease without spurring the rapid weight gain that has bedeviled patients for years. Today, the company says it got the data it was looking for in Phase II and will now press ahead into a pivotal, late-stage program to see if they can replicate the results on a larger scale.