Biogen is buying Pfizer’s PF-04958242, a first-in-class, Phase IIb-ready drug to treat several neurological and psychiatric diseases, including schizophrenia.
Biogen is paying $75 million upfront for the compound, with up to $515 million in developmental and commercial milestones, and tiered royalties in the low to mid-teens.
PF-04958242 is an AMPA receptor potentiator for the cognitive impairment associated with schizophrenia (CIAS). AMPA receptors, the company indicate, "mediate fast excitatory synaptic transmission in the central nervous system, a process which can be disrupted" in various disorders of the CNS. The compound has been studied in Phase Ib clinical trials, and showed an acceptable safety profile and positive efficacy trends across "multiple domains of cognition."
"As pioneers in neuroscience, Biogen continues to explore new ways to treat serious diseases where there are few or no options, such as CIAS," said Michel Vounatsos,Biogen’s chief executive officer, in a statement. "Given the significant unmet need and Biogen’s ability to apply its scientific expertise in this area, we are enthusiastic to advance development of this asset as we continue to expand our neuroscience pipeline, including in our emerging growth areas such as neuropsychiatry."
Biogen says it expects to start the Phase II trial in the second half of this year.
The news is likely to make investors happy, at least for a little while. Although the company remains dominant in the multiple sclerosis market, it is facing competition there and has otherwise put much of its focus on Alzheimer’s, in particular its aducanumab. But that’s a high-risk study, and investors showed just how shaky their faith in the drug are when the company’s chief medical officer, Al Sandrock, said in mid-February that they were modifying the trial for the disease, adding more patients.
Investors interpreted it as Sandrock saying the company wasn’t getting the results it expected, so it was increasing its sample size. Shares dropped by 9.1 percent, the biggest intraday decline since June 2016.
Timing—and overall trends—probably played a factor. Sandrock’s statement came the same day Merck & Company announced it was halting its Phase III trial of ferubecestat (MK-8931) for Alzheimer’s because an external Data Monitoring Committee (eDMC) had recommended it, saying the likelihood of benefits didn’t outweigh the risks. It was yet another high-profile drug failure to raise questions about the amyloid hypothesis, that the primary cause of brain damage caused by the disease is the result of accumulation of beta-amyloid plaques in the brain.
This acquisition isn’t a pivot, and it’s possible the drug may have some applications to Alzheimer’s, but it is consistent with the company’s overall focus on central nervous system disorders. Approximately 20 million people worldwide have schizophrenia, and most are believed to have some amount of cognitive impairment. "When cognition is impaired, you lose the ability to make sense of the world," said Michael Ehlers, Biogen’s executive vice president, Research & Development, in a statement. "Things we often take for granted in our daily lives, including processing information, planning and remembering, all become difficult or impossible. Cognition can be impaired in multiple neurological and neuropsychiatric diseases, including schizophrenia. And we know that the extent of cognitive deficits in patients with schizophrenia is a strong predictor of daily functioning. We look forward to quickly pursuing development of this potential innovative therapy to treat such a devastating disease."
In mid-January, Pfizer announced that it was ending its research and development into drugs for Alzheimer’s and Parkinson’s disease. It wasn’t ending all of its neurological programs, however. It was going to continue development of tanezumab and Lyrica, for chronic pain, as well as programs into rare neurological disorders.
(All Rights Reserved)