Continuing to make headlines in the neurodegenerative disease space, Biogen on Monday announced a deal to acquire a clinical-stage Pfizer asset that has potential applications in Alzheimer’s and Parkinson’s disease, for $75 million.
Cambridge, MA-based Biogen (NASDAQ: BIIB) could end up paying Pfizer (NYSE: PFE) up to $635 million in potential milestone payments and royalties, should the experimental drug—PF-05251749—reach commercialization.
The Pfizer asset is not being developed to address the underlying causes of Alzheimer’s or Parkinson’s. PF-05251749 is a novel small molecule that penetrates the central nervous system and inhibits casein kinase 1 (CK1), a protein that helps regulate the body’s circadian rhythm. Disruption of this natural sleep-wake cycle is associated with symptoms of various neurological diseases, including Alzheimer’s and Parkinson’s.
In a Phase 1a study, PF-05251749 demonstrated an acceptable safety profile and proof of mechanism. A Phase 1b study is slated for the fourth quarter of this year and will evaluate its ability to improve the symptoms of “sundowning” and “irregular sleep wake rhythm disorder,” which, respectively, affect Alzheimer’s and Parkinson’s disease patients.
A symptom of Alzheimer’s disease, sundowning—also referred to as “late-day confusion”—affects more than 20 percent of patients and causes them to become agitated in the afternoon and into the night. Irregular sleep wake rhythm disorder is a circadian rhythm disorder in which patients are severely fatigued due to fragmented sleep.
SVB Leerink analysts say the potential commercialization of PF-05251749 “should be quite synergistic with the commercialization of aducanumab and other disease-modifying medicines” for Alzheimer’s and Parkinson’s disease. The transaction is expected to close in the first quarter of 2020.
As for aducanumab, Biogen is expected to submit a biologics license application to the FDA in the first quarter of this year. If approved, it would be the first disease-modifying drug in the neurodegenerative space.
Results from the Phase 3 study of aducanumab, which were met with both optimism and skepticism, were quickly followed by the announcement of a new deal with Ionis Pharmaceuticals (NASDAQ: IONS). In this deal, Biogen licensed Ionis’s experimental Alzheimer’s drug designed to reduce the production of tau, a protein associated with the increasingly common neurological disorder. Biogen shelled out $45 million up front.
The company also days ago announced an alliance with fellow Cambridge, MA-based CAMP4. Under the agreement, which will use CAMP4’s technology to find genetic targets that could lead to new drugs, Biogen is paying $15 million up front and will foot the research bill.