| | | |   | Hello, all. Damian here with an update on the unsinkable drug they call Eylea and an appreciation for the sell-side analysts of the world. | | | Who wins the ‘endemic’ Covid vaccine market? Two years and more than 10 billion vaccine doses into the Covid-19 pandemic, the tried-and-true approach to vaccinology is finally ready for widespread use. And the impending arrival of protein-based vaccines from Novavax and Sanofi only further complicates an unpredictable market.
The news is that a vaccine from Sanofi and GlaxoSmithKline succeeded in a Phase 3 booster study, charting 100% efficacy against hospitalization and severe Covid-19. The partners plan to seek regulatory authorization as soon as possible. That puts their product about a month behind Novavax’s vaccine, also protein-based, which is currently under review in the U.S. and just started shipping to Europe.
The sales pitch for protein-based vaccines boils down to cost and familiarity. The vaccines from Sanofi and Novavax are expected to cost less than mRNA vaccines from Moderna and partners Pfizer and BioNTech, and their underlying technology has been widely used in vaccines for the flu and other infections, which could address hesitancy. What remains to be seen is just how the so-called endemic phase of Covid-19 will play out, and whether the majority of vaccine revenue has already been claimed. | Regeneron’s cash cow survives another threat Eylea, Regeneron Pharmaceuticals’ roughly $9 billion-a-year ocular treatment, has had a target on its back for the better part of a decade, and yet time and again, competitors have failed to unseat the dominant drug for common eye diseases.
The latest contestant was Kodiak Sciences, whose KSI-301 was meant to match Eylea’s effects on vision but require only a few doses per year. In Phase 3 data disclosed yesterday, KSI-301 very much did not do that, dramatically missing its primary endpoint of non-inferiority with Eylea. The news sent Kodiak’s shares down about 80%.
Meanwhile, sales of Eylea grew 19% in 2021, making it yet again Regeneron’s top-selling product. But that dominance is not guaranteed. Last month, Roche won FDA approval for a similar treatment that can be dosed every three or four months, compared to once every month or two for Eylea. And, as Baird analyst Brian Skorney pointed out in a note to clients, Eylea could face biosimilar competition as early as 2023. | Congress can score a win, without making patients lose Right now, politicians need a win, but rare disease patients could lose. In Congress’ rush to pass something, they’re considering putting huge cost increases on the development of treatments for rare diseases — increasing costs 400-800%. Tell Congress there is a better way that protects patients. Learn more at RareAccessActionProject.org. | A step toward new treatments for ALS Despite decades of research, scientists have long struggled to come up with medicines that might address the underlying causes of ALS, a rare and fatal neuromuscular disorder. But early-stage research from separate labs points to a possible explanation — and a potential path to new treatments.
As STAT’s Jonathan Wosen reports, at the center of the discoveries is UNC13A, a protein that, when healthy, influences how neurons signal one another and, when mutated, is associated with ALS. Two teams of scientists, from Stanford and University College London, discovered genetic errors that contribute to UNC13A mutation.
It’s early days for both labs, but the discovery suggests that if scientists could correct the protein-production process, they might prevent the accumulation of errant UNC13A proteins and thereby treat ALS.
Read more. | Say what you will about IPOs But at least they buy you friends on Wall Street.
Among the purported allures of going public through a SPAC is that you don’t have to pay a bunch of banks to underwrite your offering, thereby leaving less money on the table. But if you excise the bankers, you also miss out on the compulsory analyst coverage that comes with a traditional IPO. Those analysts are by no means required to say nice things about your company, but they usually do. And if you do a SPAC, you might find yourself missing the free publicity they provide.
Take for example Ginkgo Bioworks, the erstwhile synthetic biology unicorn. It went public last year in a SPAC transaction that gave it a roughly $15 billion valuation. The ensuing months have not gone great, and, as of today, Ginkgo is worth about 43% of that.
It’s impossible to say whether Ginkgo’s stock would be meaningfully more valuable if the company enjoyed enthusiastic sell-side analyst coverage, but it certainly couldn’t hurt. Instead, the average analyst price target for Ginkgo is just $11 per share, according to FactSet, and yesterday Goldman Sachs initiated coverage at $7, a 30% discount to the company’s IPO valuation. | More reads - The nation hasn’t made much progress on health equity. These leaders forged ahead anyway. STAT
- Medicare proposal on Alzheimer’s drug draws criticism from drugmakers. Wall Street Journal
- Will a looming decision on march-in rights be a groundbreaking move, or ‘one more nail in the coffin’? STAT+
- FDA limits use of GlaxoSmithKline-Vir Covid-19 drug. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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