Alkermes sinks again on official US rejection

The writing had been on the wall for Alkermes’ depression project ALKS 5461 since a negative US advisory committee vote in November. But the FDA’s official rejection, just after the markets closed on Friday, still sent the company’s stock down as much as 4% this morning. Perhaps the reality is sinking in for investors: even Alkermes appears to have given up on ALKS 5461, though a phase IIIb trial is continuing. Stifel analysts noted that it was unclear whether the FDA had signed off on this study, and the company said an upcoming meeting with the US regulator would determine whether the project had a future. Meanwhile, the group’s schizophrenia candidate ALKS 3831 might get the go-ahead, but its commercial prospects look dim after pivotal data showed that it led to weight gain, a side effect it was designed to avoid. This means that, apart from an early immuno-oncology asset, Alkermes’ main hopes still lie with its marketed products, the alcohol and opioid addiction therapy Vivitrol and the antipsychotic Aristada. However, sales of the former are slowing, and it is unclear whether the product’s revenues will hit sellside consensus of $610m by 2024.

Alkermes' assets
        Annual sales ($m)
Product Status Indication Pharma class 2017 2024e
Vivitrol Marketed Opioid/alcohol addition Opioid antagonist 269 610
Aristada Marketed Schizophrenia 5-HT1A, dopamine D2 partial agonist & 5-HT2 antagonist 94 459
ALKS 3831 Phase III Schizophrenia 5-HT2, mu opioid, dopamine D1 & D2 antagonist - 381
ALKS 8700/ BIIB098* Filed Multiple sclerosis Nrf2 pathway activator - 252
ALKS 5461 Rejected Depression Mu opioid partial agonist & kappa & mu opioid antagonist - 194
ALKS 4230 Phase I Solid tumours IL-2 fusion protein - -
Total 363 1,897
*Partnered with Biogen, Alkermes to receive mid-teens percentage royalty. Source: EvaluatePharma.

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