Life Science Today 054 – Aduhelm + Alzheimer’s, Regeneron Execs, CROS NT + Alira Health, FDA Recall

Originally Published as The Niche Podcast

We dive deep into Alzheimer’s, Regeneron execs might be overpaid, a merger in clinical research, and the FDA issues a Class 1 recall

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 Music by Luke Goodson
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Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to The Niche Podcast – Your weekly rundown of the biotech, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, we dive deep into Alzheimer’s, Regeneron execs might be overpaid, a merger in clinical research, and the FDA issues a Class 1 recall.


All The Fuss Around Alzheimer’s

One of the most watched drugs of the year, Aducanumab, has been approved for the treatment of Alzheimer’s by the FDA. Sold under the name Aduhelm, the monoclonal antibody is designed to target the amyloid beta plaques that build up in the brain and are a hallmark of the disease. No new therapeutics for the condition have been approved since 2003 and this may represent a massive industry shake-up. However, this is anything but a clean approval.

Aduhelm clearly targets Aβ plaques. That evidence is rock solid. The question has been all along, does it really matter? The data were so challenging and the therapeutic clarity hard enough to understand that it got punted by the FDA twice, first last summer, then again around Christmas. The debate basically centers on the fact that while it’s clear the therapeutic target seems to change, it’s not clear that it really makes a big difference for patients. This back-and-forth drama resulted in a pretty unique approval letter. It said, we are going to let you sell this, but if more data doesn’t show it works, we can make you stop at any time. Despite the uncertainty around approval and with the high cost of $56K/year the therapy will absolutely sell. Because, what else would you even take? However, this approval gives the FDA pretty strong leverage to pull back approvals in the future, should data merit that action.

The drama did not stop after approval. Several members of the advisory committee have resigned in protest. The advisory committee is not the FDA. It’s a group of experts who give outside opinion. They believe the drug should not have been approved based on extant data. However, about 20% of the time, the FDA goes against the advisory committee. In this case, the FDA felt the evidence for clinical benefit was sufficient, the advisory committee disagreed. But the reality is that the hubbub doesn’t end there. Currently, massive gaps exist in access to dignified aging in this country by both race and social economic status. The addition of a wildly expensive medication that those diagnosed with AD may take for the rest of their life will likely only widen the dramatic disparities in access to appropriate care. This is not exactly Biogen’s fault, but I don’t hear them crying about $56,000/person/year. Neither are investors. After the announcement, shares jumped nearly to $450+/share, prices settled down to around $400, up from $280s pre-approval.

Neurological diseases, and specifically degenerative ones like Alzheimer’s have proved pernicious and challenging targets in the last decade. The hope as an industry is that Aduhelm’s approval will spur more investment and innovation to bring more effective therapies to market. This is certainly a massive unmet need. There are also major emerging camps that argue that while Aβ plaques are the hallmark of the disease, they may not represent the underlying etiology. Just a few weeks ago we shared about one such approach. Annovis Bio’s ANVS401 showed very positive results on improved cognitive function through totally different mechanistic approaches. It may be that new therapies will supplant Aduhelm or that a combined approach is required in future. Biogen’s success has not hurt Annovis, who saw shares rise from $26/share in mid-May to $91 at closing on Friday. While the world awaits more therapeutics, Aduhelm may provide an excellent test-subject for Real-World Evidence applied to an approved therapeutic to track impact. Does it really  make a difference? As one of the millions who have lost loved ones to the disease, I certainly hope so.


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Regeneron Executives Bringing Home the Bacon or Eating It?

We mentioned back in episode 49 that Regeneron has been on a tear fiscally. And it’s true. They’re up 38% year over year for Q1, they have products coming to market across a range of areas, including dominate COVID19 therapeutics, and continued robust global growth of their Sanofi partnership, Dupixent. What could possibly go wrong? Well it turns out there is some mumbling in the investor ranks about executive pay. The CEO and CSO brought in a combined total compensation of $270M in 2020. Yep, that’s right. The CEO and CSO were paid more than a quarter of billion dollars in one year. I get it, they probably work hard and are really smart guys. And executive compensation in the Pharma industry is absolutely not cheap for any company, but these numbers are pretty hefty by any standards. Investors are grumbling. But will anything be done? These compensations may not be in line with industry standards, but Regeneron is also in the roaring 20s of growth and success which makes it hard for investors to rock the boat. If discontent continues or fiscal gains look shaky, expect renegotiations as the board works to manage investor perceptions.


CROS NT Acquired By Alira Health

Alira Health has acquired the clinical research organization CROS NT for an undisclosed amount. The deal sees the data-driven CRO, CROS NT, come under the massive and ranging suite of therapeutic development solutions provided by Alira Health. The private owned Alira has made a number of acquisitions in recent years. This one is backed by a $35M equity financing round back in mid-April. Alira’s data-heavy focus and solutions pair well with CROS NT. I’d love to dig deep and tell you why this is really unique and amazing merger. However, it reads like a pretty standard M&A in the CRO and CRO adjacent spaces: Find a decent organization with reasonably aligned verticals and make a deal.


Innova Get’s More Than a Wrist Slap

The FDA has issued a Class 1 recall of Innova’s rapid COVID19 antibody test. This is the most severe recall possible by the FDA and is contains significant language about the actions of Innova that brought about this issuance. The subject in question is a rapid antibody test that theoretically provides quick feedback. The letter asserts that Innova has mislabeled products, not followed GCP, and sold product when they were not approved. The language of the notice is strong, for the FDA, and includes phrases like your claims about your device “appears unsupported by any clinical data.” The FDA basically says, you’re not producing this correctly, you’re not following rules, you’re selling this when you’re not approved to, and you have straight made-up data and lies that you have put out there publicly. All of Innova’s rapid COVID19 antigen tests should be disposed of in the trash. I suspect there will be major global repercussions across the pond where the UK purchased 380M of the tests. For , their web-presence is blacked out, their website is down, they have a Class 1 FDA recall on products they’ve sold to governments. Lawsuits will follow, period.


 Closing Credits

Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.