Alkermes is handed a CRL for ‘3831, marking another setback on the R&D front
Alkermes $ALKS is going to have to wait some more before launching its anti-psychotic combo drug ALKS-3831. The FDA has handed the biotech a CRL, rejecting the application in the company’s latest setback in R&D.
After getting a majority of the outside experts that reviewed the drug for the FDA to provide a thumbs up on approval, the biotech reported today that their manufacturing operations didn’t pass muster during their remote inspection of records — an alternative to a formal survey the agency adopted last summer as a result of the pandemic.
Alkermes emphasized that regulators didn’t raise any questions about the combo itself, which is designed to provide the anti-psychotic therapy Zyprexa without the threat of severe weight gain. There are no new requirements for additional studies. But the manufacturing review unveiled a problem with the tablet coating process at their factory in Wilmington, OH.
According to Alkermes:
The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company believes this issue has since been resolved and that sufficient data is available to address these observations. Alkermes is preparing those data for submission and plans to work closely with the Agency to resolve these items in a timely manner and complete labeling discussions for the application.
Alkermes has run through a series of frustrations on the R&D front in recent years. A key depression drug failed a late-stage study in the spring of last year. And even if they get an OK on ‘3831 soon, the company still faces low expectations on the sales front, with peak estimates in some cases hovering around $300 million.
Paul Matteis at Stifel was left shaking his head over the broader implications for Alkermes, noting:
(T)he issue here is not just related to a delay–it’s also a negative read on execution, with a potential follow-through onto stock sentiment, as this represents another regulatory setback for ALKS after the high profile rejection of ALKS5461 in MDD two years ago. These are obviously very different situations. But for ALKS, the pipeline is naturally a major driver of value creation and operating leverage, so this could increase pre-existing pressures to make a more concerted effort toward managing spend/investments.