Biogen said today it will expand its neuroscience pipeline into neuropsychiatry by agreeing to acquire from Pfizer the Phase II-ready cognitive impairment associated with schizophrenia (CIAS) candidate PF-04958242 for up to $590 million-plus.
PF-04958242 is an α-amino-3-hydroxy-5-
Biogen said it plans to launch a Phase IIb trial of PF-04958242 in the second half of 2018
“As pioneers in neuroscience, Biogen continues to explore new ways to treat serious diseases where there are few or no options, such as CIAS,” Biogen CEO Michel Vounatsos said in a statement. “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.”
Biogen’s pipeline has long focused on multiple sclerosis (MS) and neuroimmunology as well as, Alzheimer’s disease and movement and neuromuscular disorders. The compnay’s top-selling drug, the relapsing MS treatment Tecfidera® (dimethyl fumarate), racked up $4.214 billion in revenues last year. Biogen’s pipeline is co-led by two late-stage Alzheimer’s candidates, aducanumab (BIIB037) and E2609, both being codeveloped with Eisai, and the MS treatment BIIB098 (monomethyl fumarate prodrug), licensed from Alkermes.
PF-04958242 represents Biogen’s first program in neuropsychiatry, which it considers one of its four strategic emerging growth areas, along with pain, ophthalmology, and acute neurology.
“Our access to a range of therapeutic modalities, including gene therapy, biologics, antisense oligonucleotides, and small molecules, will allow Biogen to bring new options to patients suffering from neuropsychiatric and neurodevelopmental disorders,” Biogen stated on its website. “Biogen is actively pursuing partnerships and collaborations with academic and industry groups to develop innovative solutions for these patients.”
Pfizer’s selloff of PF-04958242 comes more than a month after the pharma giant kicked off 2018 by saying it was ending R&D of neuroscience treatments and disclosing plans to eliminate about 300 jobs tied to early-stage R&D programs—of which some 200 were based in Cambridge, MA, and Andover, MA, and the rest in Groton, CT.
“Driven by Science”
Among the early-stage programs Pfizer ended was PF-04958242, which was listed as one of several “Projects Discontinued from Development since October 31, 2017” on the company’s most recent pipeline update, issued January 30.
“This decision was driven by science, not cost,” Mikael Dolsten, M.D., Ph.D., president of Pfizer Worldwide Research and Development, stated January 11 on the company’s website. “Our reallocation of funding will allow us to place greater focus on areas where we believe we have the strongest possibility of bringing important therapies and vaccines to patients in the near term. Among those areas, Dr. Dolsten added, were cancer, vaccine infections such as Clostridium difficile and Staphylococcus aureus, chronic inflammatory diseases, Duchenne muscular dystrophy, chronic pain conditions, and NASH, or nonalcoholic fatty liver disease.
Months before the January announcement, Pfizer terminated a Phase I study of PF-04958242 (NCT02855411) in CIAS as of October 4, 2017 “following an internal portfolio prioritization. It is not due to any safety concern or change in benefit:risk assessment,” the company stated on Clinicaltrials.gov.
In another study, whose results were published earlier last year, researchers concluded that PF-04958242 and other AMPA receptor potentiators “may have a role in the treatment of the cognitive symptoms” associated with schizophrenia, but not positive or negative symptoms.
PF-04958242 had also been evaluated for age-related sensorineural hearing loss. A study published in 2015 showed no significant change from baseline compared with placebo in the primary or secondary study endpoints of Pure-tone average, speech discrimination score, and speech in noise testing at 1 or 5 hours after receiving treatment.
Biogen agreed to pay Pfizer $75 million upfront, up to $515 million in payments tied to achieving development and commercialization milestones, and tiered royalties in the low- to mid-teen percentages.
The deal is set to close in the second quarter, subject to customary closing conditions that include the expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the U.S