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Shaky Prospects For Eli Lilly's Donanemab For Alzheimer's Disease

Lane Simonian profile picture
Lane Simonian


  • At this point, Eli Lilly's donanemab performs only a tick better than Biogen's aducanumab/Aduhelm for Alzheimer's disease.
  • The FDA may grant accelerated approval to donanemab as it did for aducanumab based on the removal of amyloid plaques as a surrogate biomarker.
  • Medicare, though, will probably deny general coverage to donanemab as it did for Aduhelm based on insufficient clinical evidence.
  • Investors should consider selling some shares of Eli Lilly given this likely outcome.

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The chances that the FDA will grant accelerated approval to Eli Lilly’s (NYSE:LLY) donanemab for Alzheimer’s disease are fairly good (accelerated approval allows a drug to be sold based on surrogate biomarker data while further

This article was written by

Lane Simonian profile picture
Retired history instructor. Alzheimer's disease researcher for the past decade.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs.  This advice is informed by  a background in biology (conservation, ecology, evolution, environmental science, and biochemistry) and seventeen years of a very in depth review of the research on Alzheimer's disease.

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Comments (31)

Doc 224899 profile picture
No clinical benefit...and FDA predicted to approve??!!

Don't waste our time, FDA! Approve simufilam! Get on with it! Jeeeesh!
Interesting write-up. Thank you.

Do you also happen to have an opinion on Vivoryon? They have a small-molecule inhibitor for N3pE (I understand the same target as for donanemab, just via a different pathway), which is in a Phase 2b trial. The interim safety data come in June 2022. Earlier, they spoke about the potential of combination therapy with anti-amyloid antibodies, which was substantiated by a preclinical work they did on mice.



Thank you!
Lane Simonian profile picture
You are right same target (pyroglutamate-modified amyloid), different mechanism (glutaminyl cyclase inhibitor). Usually when you prevent the buildup of different forms of amyloid you have fewer serious side effects than when you use anti-amyloid antibodies, but the overall results in terms of slowing down the progression of the disease don't seem to change much. Maybe that will also be the case of combining Vivoryon with anti-amyloid antibodies (in terms of efficacy at least). The problem remains that the factors that initially trigger Alzheimer's disease and are responsible for much of its early progression remain even if you inhibit the formation of and remove amyloid.
Dividend Ambassador profile picture
LLY has just been MASSIVELY overvalued. I did sell some shares which is incredibly rare for me. It just got bid up to absurd levels.
Laura Lea profile picture
@killiondt I agree. The chart is topping out soon I think
@killiondt "LLY has just been MASSIVELY overvalued" - Is it because of their prospective new Alzheimer's medication?
Dividend Ambassador profile picture
@Totenpole might not even work. Absurd valuation.
" For Eli Lilly with expectations a bit more tempered based on the Biogen’s experience, the increase has been over 100 points. But in the end, I expect Eli Lilly to give up most of these gains."
I totally do not agree with this statement. Here are my reasons for disagreeing with this. LLY is not just an Alzheimers product Company.

1) Revenue attributable to newer medicines grew over 24% and now represents nearly 61% of the core business this quarter
2) Completed another $750 million in share repurchases Q4 2021. Completed $1.5 billion in share repurchases in Q1 2022
3) Gross margin as a percent of revenue increased 70 basis points to 76.1% in Q1 2022
4) Jardiance is now the first and only heart failure therapy to demonstrate statistically significant risk reduction in cardiovascular death or hospitalization for heart failure regardless of ejection fraction.
5) the Phase III trial study in Jardiance for chronic kidney disease was stopped early due to clear positive efficacy
6) Regulatory submissions for Tirzepatide for type 2 diabetes in the U.S. to which LLY applied a priority review voucher, as well as the EU,
U.S. launch in Diabetes expected fall of 2022.
7) 14% weight loss in Diabetics and the benefit of that being even higher in the non-diabetic obesity population. Obviously, just a massive unmet need 110 million Americans live with obesity. Only about 3% of them are treated with some type of anti-obesity medication.
SURMOUNT-1 report on Tirzepatide in Obesity 2022. - reduction in Non-Diabetics. (greater than found in the diabetics ) up to 22.5% weight loss at 72 weeks (depending on dosage ) SURMOUNT-1 showed up to 60% of patients achieved at least 20% body weight reduction at 72 weeks, No other product comes anywhere close to this. The overall treatment discontinuation rates range from roughly 14% to 16% in the tirzepatide arms compared to over 26% for placebo. SURMOUNT - 3 and 4 are ongoing studies .
8) LLY stands on 2 solid pillars and 2 additional pillars to appear in 2022.
Trulicity and Verzenio currently and Tirzepatide and Alzheimers product for the near future.
Trulicity is taken once weekly and growing very fast. (definition on pillar – greater than $5.0 Billion a year )
9) Verzenio for Breast Cancer ( B.C.) proved successful in the Adjuvant setting where as the established product from the same class Ibrance of Pfizer reported a negative study. This ( adjuvant setting ) is a huge piece of the B.C. pie.
10) Tirzepatide is an outstanding product for Diabetes. the most potent to reduce blood sugar and reduce weight.

11) As for the Alzheimers product we now have MRI and PET scan evidence that it significantly reduces the Plaques and Tangles in the brain. The TRAILBLAZER-2 is a major Phase 2 study. US government will pay for patients in an Alzheimers study if their meds. are normally covered by Medicare. This study will report spring of 2023. FDA approval expected Mid. 2023.
12) Mirikizumab ( Il-23) (for ulcerative colitis as the first indication approval ) submitted to FDA for approval
13) lebrikizumab (AD ) ( Il- 13 ) has shown positive data ( Phase 3 ) in the Immunology area. Launch expected in 2023. In 2026 they will bring in $5 Billion together ( Mirki + Lebri ) . Just as a reminder LLY already has a foot in the market place on Immunological products Taltz and Olmiant
14) The initiation of a rolling submission in the U.S. for pertibrutinib in mantle cell lymphoma
15) LLY began dosing patients in the first of five Phase III trials for investigational weekly insulin basal insulin FC or BIF. The trial compares weekly BIF to insulin degludec where patients are currently treated with basal insulin
16) 15% increase to the dividend for the fourth consecutive year was announced end 2021.
We all know who the leader in the race for safe and effective AD treatment is. A simple small molecule, makeable, drug-able, therefore viciously attacked for being what it is: SAVA's Simufilam.
Sr. Lane, what do you think of cogrx.com/...
Lane Simonian profile picture
This one seems like a more complicated version of an anti-amyloid oligomer approach to Alzheimer's disease, so it does not seem like it would have any effect on other factors involved in the onset and early progression of Alzheimer's disease.
Gordon Gecko was a Commie profile picture
@Lane Simonian I think you are actually being a little too kind to Lilly and Donanemab here. Their ph2 data was generated from an absurdly cherry picked pool of patients that could never be replicated in the real world of medical practice: of 1955 patients assessed, 1683 were excluded. They were trying to find patients with 'just the right amount' of amyloid (not too much, not too little) and essentially no tau. that will always be a very small slice of the AD population. like adu, E4 carriers are most likely to experience serious ARIA-E...
Thanks for the write up Lane. Where does that leave Anavex at this point? Anavex 2-73 Blarcamesine sure looks like its on track. Do you see this as the explosive surprise for the AD community ? Results due in a just a few months. What is interesting, is all the positive results with A 2-73 across multiple CNS applications ( Parkinsons Rett, AD, etc).....strong results, no safety issues. Are we close to a real CNS miracle drug ????? Do you think big pharm is trying to make AVXL go away ????
rt94103 profile picture
@Flash9875 At the 700M mkt cap big pharma can just buy AVXL instead. Might 2B get it done?

In that scenario a bidding war would be nice though, I'd hate to get sold out cheap before things get good...
Lane Simonian profile picture
@Flash9875 I expect that Anavex's upcoming trial results for both Alzheimer's disease and pediatric Rett syndrome will be good based on previous trials and on the mechanisms of action. For both indications, some patients may see some improvements that will probably be sustained over a long period of time.

Many neurological conditions share some basic features, so hopefully a drug that helps with one of these conditions will help with others as well.
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