Ahead of aducanumab filing, Biogen nabs Pfizer castoff for $75M to address Alzheimer's, Parkinson's symptoms
Biogen believes (not everyone agrees) it has a disease-modifying therapy for Alzheimer’s on the cusp of an FDA approval. Now it’s bringing in an early drug to also treat one of its symptoms.
PF-05251749 is an inhibitor of casein kinase 1, a family of enzymes key to the regulation of circadian rhythm, that Pfizer had taken through Phase Ia before culling its entire neurosciences unit. While some assets were salvaged in the form of a spinout, this apparently went up for sale and it’s going for $75 million upfront. Biogen has committed to $635 million in milestones.
In addition to sundowning in Alzheimer’s — a state of confusion, anxiety, aggression, agitation or restlessness besetting about 20% of all patients in the evenings — Biogen also sees potential in a non-motor symptom of Parkinson’s dubbed irregular sleep wake rhythm disorder. Patients with ISWRD have trouble sleeping at night and experience subsequent daytime sleepiness and severe fatigue, disrupting their daily lives.
At Pfizer, PF-05251749 had been tested in around 100 healthy volunteers (in one case in conjunction with melatonin). Biogen will now initiate its own Phase Ib studies for each of the two indications it highlighted
For Baird analysts, it’s all a bit reminiscent of the BMS-986168 (gosuranemab) deal from 2017, wrote Brian Skorney.
Back then Biogen paid $300 million upfront — sizable, as with this new deal — to acquire gosuranemab from Bristol-Myers Squibb — another big pharma partner.
“Recall, we recently noted that gosuranemab flopped in the pivotal Phase 2 PASSPORT trial in patients with progressive supranuclear palsy (PSP),” he added. “With respect to gosuranemab, it seems that Biogen got the short end of the stick, however, only time will tell as to whether or not the case will be the same with respect to PF-05251749.”
Al Sandrock, Biogen head of R&D and big aducanumab cheerleader, remains optimistic about the potential to address behavioral and neurological symptoms using a CNS-penetrant drug.
“This asset is highly complementary to our existing pipeline of potential disease-modifying therapies in Alzheimer’s and Parkinson’s diseases,” Sandrock, who’s also held onto the CMO title, for now, said in a statement.
The deal kicks off a year when Alzheimer’s will loom ever larger at Biogen, as the company begins to find out whether its decision to resurrect the aducanumab program following post hoc analysis of two Phase III studies (one of which still failed regardless) will fly with FDA regulators. The biotech has said it’d file for approval in early 2020.
Their theory is that patients needed to be consistently exposed to a high-dose — 14 doses at 10mg/kg — as well as a better titration regimen to reap the full cognitive benefits of aducanumab. But critics slammed the argument, contending that even if that were true, it would have to be borne out by a third, confirmatory study before the beta-amyloid binding antibody can be approved.
“We don’t file willy nilly,” Sandrock previously said in defense of the decision to shoot for an OK with what they have. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”