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the Alkermes hypothesis. The Alkermes drug added to the mix, ALKS33, is an opioid receptor modulator that was designed to curb addictive behaviors. It has passed a mid-stage clinical trial as a treatment for alcohol dependence, but hasn’t been tested alone as treatment for weight loss. The drug’s future as a treatment for alcohol dependence is on hold for now, Pops says, until the company can agree with the FDA on mutually acceptable goals for future studies.
For now, the proprietary Alkermes drug will need to be given in combination with olanzapine in clinical trials. If the combo continues to progress, Alkermes will want to move ahead with a drug that puts both active ingredients into a single pill. “Ultimately, it will be a single tablet, but we’ll have talk to FDA about it,” Pops says.
Alkermes made the announcement just a couple of days before jetting off to the JP Morgan Healthcare Conference in San Francisco, the biotech industry’s biggest annual event for investing and dealmaking. The company is also announcing today it has gotten a patent that lasts until 2030 on its once-monthly injectable form of aripiprazole lauroxil. That drug for central nervous system disorders, including schizophrenia, is designed to come as a once-monthly injection that it hopes will improve upon Bristol-Myers Squibb’s blockbuster treatment aripiprazole (Abilify). Alkermes is also planning to release clinical data in the first half of 2013 on ALKS5461, a combo drug for treatment-resistant depression that is also based partly on ALKS33.
The overarching story this year at Alkermes will be more about the R&D pipeline for central nervous system disorders, and less about the big merger with Elan Drug Technologies, first announced in May 2011. Essentially, that’s old news. And while people were rightly paying attention to how that merger would change the complexion of Alkermes, they might not have noticed some of the drugs that were progressing in the pipeline. “Our CNS pipeline is getting more exciting,” Pops says.