San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years.
Shares of Voyager Therapeutics Inc. and its partner, Neurocrine Biosciences Inc., fell in early trading Dec. 23 after Voyager announced an FDA clinical hold on the phase II Restore-1 trial of VY-AADC, an adeno-associated virus-based gene therapy Neurocrine is developing as NBIb-1817 for the treatment of Parkinson's disease. The trial had been paused since at least November as its data safety monitoring board reviewed MRI abnormalities in some study participants.
Wall Street is liking the prospects of Neurocrine Biosciences Inc.’s NBI-827104, in the rare pediatric indication called epileptic encephalopathy with continuous spikes and waves during sleep. San Diego-based Neurocrine is moving the orally active, brain-penetrating T-type calcium channel blocker, licensed from Idorsia Ltd., of Allschwil, Switzerland, into phase II trials.
Bold up-fronts and even bigger milestones defined ambitious neurology deals Abbvie Inc. struck with Voyager Therapeutics Inc. in 2018 and 2019. With vectorized antibodies, they planned to target multiple indications tied to excess aggregations of tau and tragic synucleinopathies. Considerable progress was made, said Omar Khwaja, Voyager's chief medical officer. But despite millions of dollars invested in the programs, Abbvie has now decided to quit the venture, leaving Voyager to either go it alone or find a new partner in its work on the challenging indications.
Neurocrine Biosciences Inc.’s chief business development and strategy officer, Kyle Gano, said “there was really no playbook” for the deal in which his firm is paying Takeda Pharmaceutical Co. Ltd. $120 million up front for an exclusive license to seven programs, including three clinical-stage assets targeting the notoriously difficult indications of schizophrenia and treatment-resistant depression (TRD), as well as depression-related anhedonia.
A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.
In its second large deal of the calendar year, Neurocrine Biosciences Inc. acquired the rights to Xenon Pharmaceutical Inc.’s selective sodium channel inhibitor for treating epileptic encephalopathy. Xenon receives $30 million up front, $20 million in equity and up to $1.7 billion in potential development, regulatory and commercial milestone payments.
