- Biogen Inc. announced Monday it will acquire from Pfizer Inc. a Phase 2b-ready compound designed to treat cognitive impairment associated with schizophrenia.
- Biogen will pay an upfront fee of $75 million to gain access to the candidate, and has agreed to pay up to $515 million in potential development and commercialization milestones.
- Although Biogen may face little competition in this class for this indication, GlaxoSmithKline plc does have a similar investigational compound that is further along in clinical trials.
Biogen, already a major player in neuroscience, dubbed Pfizer's compound its "first program in neuropsychiatry" — a therapeutic area the biotech expects will grow.
The buy also represents the first sale of a neuroscience asset by Pfizer since its announcement earlier this year of plans to discontinue research in neuroscience discovery and drug development.
In Phase 1 trials, Pfizer's candidate was shown to be safe, and Phase 1b showed the drug could affect cognition and influence functional circuit activation. Pfizer had planned to test the drug as a treatment for age-related hearing loss as well, but terminated those studies after Phase 1.
The compound is still in testing, however, for its ability to help reverse learning and memory impairments that are a result of exposure or treatment with ketamine.
Biogen's new foray into AMPA receptor potentiators will not go entirely unchallenged, however. GlaxoSmithKline has a compound in Phase 1 trials that also focuses on modulating AMPA for the treatment of schizophrenia, by examining how well increasing the activity of AMPA improves cognition.
Another company called RespireRx Pharmaceuticals Inc. is investigating ampakine (a subgroup of AMPA receptor positive allosteric modulators) in combination with lozapine, olanzapine or risperidone for the treatment of schizophrenia. However, another similar drug trial looking at ampakine for cognitive deficits in schizophrenia was withdrawn.
Biogen expects the deal to close in the second quarter of 2018.
Receptors for AMPA mimic the effects of the chemical messenger glutamate. AMPA receptors are believed to be the prime mediator of fast synaptic transmission in spinal motor neurons.
There aren't too many trials investigating AMPA as a receptor potentiator — the ones that exist appear to be in early stages and one was withdrawn in 2005 after investigation as a treatment of major depressive disorder. A search of the government database clinicaltrials.gov yields 26 results for studies investigating "AMPA" — although they primarily look at AMPA blockade rather than AMPA enhancement, which is the focus of Biogen's acquired drug.
Eisai Co. Ltd. markets an AMPA antagonist called Fycompa (perampanel), which is indicated for the treatment of epilepsy. While it may help to control seizures, it comes with a warning of serious psychiatric and behavioral reactions that could be considered life-threatening. Fycompa is also being investigated for its ability to treat amyotrophic lateral sclerosis, and there is a Phase 2 trial currently recruiting patients.