Cariprazine’s hit-and-miss record in late-stage development has been extended by a stinging setback. Investigators for Allergan ($AGN) and its partner Gedeon Richter say that the drug flopped in a Phase III depression study, but will nevertheless go back into another pivotal study in search of more promising results.
Persistence in late-stage work is the only reason this drug is still in the spotlight. Back in early 2015 I covered their small, successful Phase III trial for cariprazine in schizophrenia, which was good enough for the developers to send back to the FDA for a later approval (as Vraylar), even though they had rejected the drug in 2013. Richter has doggedly maintained its faith in the drug after once projecting peak potential sales at a blockbuster rate of $2 billion a year, which shrinks to $200 million in the hands of some analysts.
As the companies noted in their statement this morning, it’s not unusual for a Phase III depression study to fail. Alkermes recently ran into the same issue with its first shot at a Phase III. The company failed and saw $4 billion in market cap dissolve, though it too believes that a followup Phase III can still deliver the goods. The track record on Phase III depression studies is littered with failure and just the occasional success.
Regulators often require several late-stage studies for a depression drug, largely because the placebo effect can be so strong in a depression study it’s the only way to advance new drugs, which often go on to become wildly hit-and-miss in a therapeutic market that requires plenty of experimentation. Investigators pointed to another study (MD-75) in which they say they got a positive readout for depression, but this time around the drug arm failed to separate from a placebo, offering no more help than a sugar pill.
Richter didn’t lose the same percentage of equity as Alkermes, but its stock was still damaged on the news.
The companies are also conducting two Phase III studies for bipolar depression. Allergan wound up with rights to the drug after a series of mergers, tracing its ownership back to a pact by Forest Laboratories.
“We are disappointed with the results of this trial. However, we believe that our plan to move forward with another Phase III study in (major depression) coupled with our previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine program,” said David Nicholson, chief R&D officer at Allergan.
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