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Alkermes Targets Bipolar Disorder and Schizophrenia
02/13/2020 5:00 am EST
The NDA seeks approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar disorder and has been accepted by the FDA for review. The NDA has been given a PDUFA date of Nov 15, 2020.
ALKS 3831 is an oral atypical antipsychotic to be taken once daily. It is designed to provide the efficacy of olanzapine while mitigating the weight gain typically associated with olanzapine.
Alkermes is seeking approval for 10 mg of samidorphan coformulated with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine in a bilayer tablet. Expectations are quite low for this compound.
In addition, with the Vumerity approval from partner Biogen (BIIB) late last year, Vivitrol coming further to address opioid overdoses, Aristada moving up in its launch/learning curve, plus the novel IL-2 cancer compound, in our view, we believe ALKS shares are have bottomed.
In our view, the Board and CEO Rich Pops will not sit around too long at current levels without making further moves to enhance shareholder value.
The recent patent victory for Biogen versus Mylan (MYL) regarding Tecfidera was a nice positive for Alkermes as Mylan was poised to start marketing generic Tecfidera as early as mid-2021.
The decision that will keep generic Tecfidera off the market until 2028 and allows Vumerity to avoid generic competition from a similar molecule just as it is being launched. We recommend purchase of ALKS.
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