Biogen moves forward to Phase 2b with former Pfizer asset

Biogen will pay as much as $515 million for PF-04958242, an AMPA receptor potentiator designed to facilitate neurotransmission

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CAMBRIDGE, Mass.—Back in January, Pfizer announced it was closing up shop on its neuroscience program, saying that it needed to “focus on those areas where our pipeline, and our scientific expertise, is strongest.” That meant not only a loss of jobs, but also nine neurologically oriented drugs in clinical development potentially on the auction block—in addition to possibly other neuro assets.
And, as Pfizer looks to clear its house of such assets, Biogen Inc. has become an eager buyer of one them, announcing March 12 that it had signed an agreement to acquire PF-04958242, a first-in-class, Phase 2b-ready AMPA receptor potentiator for cognitive impairment associated with schizophrenia (CIAS). AMPA receptors mediate fast excitatory synaptic transmission in the central nervous system, a process which can be disrupted in a number of neurological and psychiatric diseases, including schizophrenia.
Of the more than 20 million people worldwide living with schizophrenia, the majority of them are believed to suffer some degree of cognitive impairment attributable to the disease, bringing CIAS to the forefront as one of the biggest unmet needs in the effective treatment of schizophrenia.
The purchase will include an upfront payment of $75 million with up to $515 million in additional development and commercialization milestone payments, as well as tiered royalties in the low- to mid-teen percentages.
PF-04958242 has already shown an acceptable safety profile and treatment effect trends across multiple domains of cognition in Phase 1b clinical studies. Biogen intends to start its Phase 2b investigation into the novel therapeutic in the second half of this year.
“As pioneers in neuroscience, Biogen continues to explore new ways to treat serious diseases where there are few or no options, such as CIAS,” stated Michel Vounatsos, Biogen’s CEO. “Given the significant unmet patient 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.”
“When cognition is impaired, you lose the ability to make sense of the world. Things we often take for granted in our daily lives, including processing information, planning and remembering, all become difficult or impossible,” noted Michael Ehlers, executive vice president of research and development at Biogen. “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.”
Biogen isn’t a stranger to neurology, as it has an Alzheimer’s disease candidate (aducanumab) in late-stage clinical trials right now—albeit a possibly shaky one, as it targets the amyloid theory of Alzheimer’s causation and many drugs on that path have been failing to meet expectations in trials lately—but the PF-04958242 deal is, the company says, its first foray into neuropsychiatry therapeutics.

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