Allaying Aduhelm concerns, plus Master Protocols, Arvinas-Pfizer: a BioCentury podcast

By Jeff Cranmer, Executive Editor

July 27, 2021 2:14 AM UTC

Biogen is pushing back against the mounting negative takes on its new Alzheimer’s therapy Aduhelm. Can Alfred Sandrock’s open letter turn the tide? On the latest edition of BioCentury This Week, BioCentury’s editors discuss the Biogen head of R&D’s attempt to clear up what he called the “extensive misinformation and misunderstanding” about Aduhelm circulating among patients, caregivers and physicians. They also discuss BioCentury’s analysis of 16 master protocol trials for COVID-19 therapies as well as the largest protein degradation licensing deal to date.

Aduhelm aducanumab-avwa has generated a significant amount of controversy since FDA set aside the recommendation of the agency’s advisory panel and granted the therapy accelerated approval. In recent days, an ICER panel voted unanimously that evidence to demonstrate the drug’s health benefit is lacking, and the Cleveland Clinic and Mount Sinai Health System said they will not administer the therapy.

Now Biogen Inc. (NASDAQ:BIIB) is stepping up its initiative to gain control of messaging about the drug.

The letter’s simplified messages could resonate with its audience, or the information and nuance left out of the discussion could exacerbate confusion, says BioCentury Executive Editor Selina Koch.

Despite the success of the U.K.’s RECOVERY and REMAP-CAP studies, master protocol trials on the whole were not the force for rapid, efficient drug development during COVID-19 that they should have been, argues Senior Editor Lauren Martz. But the failures have pointed to what works and doesn’t, and set the ground rules for a network of such trials to be deployed when disaster next strikes.

In this week’s Deal in Focus, Martz and Executive Editor Jeff Cranmer discuss the new deal between longtime partners Pfizer Inc. (NYSE:PFE) and Arvinas Inc. (NASDAQ:ARVN) for ARV-471. The pharma is committing $1 billion up front and a potential $1.4 billion in milestones in a partnership designed to position the oral, selective estrogen receptor degrader as an endocrine backbone therapy for breast cancer patients across the treatment paradigm.

The transaction is the latest and largest vote of confidence in the increasingly active targeted protein degradation sector, Cranmer says.

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