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Biogen just can’t quit Alzheimer’s, licensing another drug from Pfizer

Snaps up clinical-stage candidate for $75m upfront

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Biogen’s mixed fortunes in Alzheimer’s drug development haven’t stopped it snapping up a clinical-stage candidate for the disease from Pfizer for $75m upfront.

The subject of the deal is PF-05251749, a casein kinase 1 (CK1) inhibitor that is being developed to address sleep-related disturbances linked to Alzheimer’s and other neurological disorders such as Parkinson’s disease, rather than trying to tackle the underlying neurodegeneration.

Specifically, it will be developed for ‘sundowning’ in Alzheimer’s patients – which causes them to become disorientated and anxious later in the day – and irregular sleep wake rhythm disorder (ISWRD) in Parkinson’s, which causes fragmented sleep at night.

PF-05251749 is thought to work by resetting the central body clock, known as the suprachiasmatic nucleus of the hypothalamus, that controls circadian rhythm as well as other metabolic functions.

Pfizer has taken the drug through early-stage safety testing, but decided to duck out of neurological disease R&D in early 2018, placing the CK1 inhibitor outside its research priorities. It wasn’t among the projects that the big pharma subsequently divested into spin-off firm Cereval Therapeutics.

Biogen – which has been leading the charge among companies vying to develop effective, disease-modifying therapies for Alzheimer’s – is committing to pay Pfizer milestone payments of up to $635m in addition to the upfront fee, as well as royalties on any future sales. It says it will start phase 1b trials of PF-05251749 before the end of the year.

Biogen remains committed to Alzheimer’s despite dozens of failed clinical trials and the increasing precariousness of the amyloid hypothesis, on which it has hung most of its research projects in this area.

Its pipeline of Alzheimer’s drugs is currently headed by Eisai-partnered aducanumab, an anti-amyloid therapy that was abandoned and then spectacularly re-activated on the strength of a fresh look at data from its phase 3 programme in 2019. It’s due to be filed for approval this year, although not all are convinced by the data.

It’s determination to make headway in Alzheimer’s remains despite suffering a setback last year after it stopped development of another Eisai-partnered amyloid-targeting drug – BACE inhibitor elenbecestat – due to an unfavourable risk to benefit profile.

Aside from aducanumab, it has another amyloid drug (BAN2401) in phase 3 testing, plus three drugs that target tau protein – including two anti-tau antibodies (gosuranemab in phase 2 and BIIB076 in phase 1) and an Ionis-partnered antisense candidate called BIIB080.

The latest licensing deal adds to that pipeline and makes it clear that Biogen has no intention of backing away from Alzheimer’s anytime soon. It comes just a few weeks after the biopharma company agreed a $200m deal with Ionis for BIIB080.

Crucially, PF-05251749 gives Biogen a clinical candidate that could have a lower bar to clear to show approval, as it will only target a specific symptoms of Alzheimer’s and Parkinson’s rather than trying to alter the underlying trajectory of the disease.

“This asset is highly complementary to our existing pipeline of potential disease-modifying therapies in Alzheimer’s and Parkinson’s diseases,” said Alfred Sandrock, head of R&D and chief medical officer at Biogen.

“Many patients with Alzheimer’s and Parkinson’s suffer from debilitating sleep disorders and agitation, and we believe that the regulation of the circadian rhythm may hold promise in addressing these challenging behavioural and neurological symptoms,” he added.

Article by
Phil Taylor

14th January 2020

From: Sales



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