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' multiple sclerosis prodrug looks good in Phase I, has Biogen Idec's Tecfidera in its sights
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.
This week, Ardsley, NY-based Acorda Therapeutics agreed to buy Civitas Therapeutics for $525 million to get its hands on its Parkinson's disease drug and the special technology needed to deliver it. But there is a manufacturing side story to this deal that goes back more than a decade and involves Alkermes, which is picking up a piece of the payout in this deal.
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 its sights set on Biogen Idec's blockbuster multiple sclerosis treatment, advancing a me-better candidate of its own into Phase I study.
Startup Alkeus is being sued by Irish drugmaker Alkermes for trademark infringement. According to the Boston Business Journal, the 25-year-old Alkermes filed the lawsuit on May 27, alleging that the smaller company's name could easily be mistaken for that of the more established developer of central nervous system disorder drugs.
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.
J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.