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Good morning! A crowdsourced Readout at present, to make certain, with contributions from STAT’s Jason Mast, Elaine Chen, and Jonathan Wosen. We get into earnings from Novo Nordisk, Amgen, and Illumina, and see that ICER isn’t so enthused a couple of gene remedy from Sarepta.
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Novo Nordisk CEO defends worth of Wegovy, Ozempic
Novo Nordisk CEO Lars Fruergaard Jørgensen is standing by the price of Ozempic and Wegovy, regardless of an ongoing Senate investigation into the corporate’s pricing. In an earnings name yesterday, he stated the medicine provide “a beautiful worth proposition” as they’re priced equally to earlier, much less efficient iterations of this class of medicine.
Though he conceded that the variety of individuals taking the medicine “is to a point placing strains on well being care methods,” STAT’s Elaine Chen writes, the complete worth of those diabetes and weight problems medicine has but to be realized. Ozempic’s record worth is $969 month-to-month; Wegovy’s is $1,349. Executives on the decision stated that the web costs for these medicine have already come down, and can proceed to take action as extra individuals take it — and as competitors will increase.
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On the ethics of live-brain analysis
The elimination of small quantities of mind tissue from desperately ailing sufferers, finished as a part of a Mount Sinai analysis mission, triggered alarm bells on the FDA and has raised broader questions concerning the scientific and moral justification for live-brain analysis. Journalist and STAT contributor Katherine Eban joins “The Readout LOUD” this week to debate the findings of a two-year investigation.
Additionally on this week’s episode, STAT’s Adam Feuerstein and Allison DeAngelis talk about Novartis’ effort to accumulate MorphoSys, and the newest information on Eli Lilly and Novo Nordisk’s blockbuster weight problems medicine with Elaine Chen.
Pay attention right here.
ICER casts doubt on Sarepta’s DMD gene remedy
From STAT’s Jason Mast: The drug-pricing watchdogs over on the Institute for Scientific and Financial Assessment, or ICER, typically take a dim view of contemporary drug pricing — besides in terms of gene remedy. These remedies, the nonprofit has stated, typically present the years-long advantages for extreme illness that justify a multimillion-dollar price ticket.
Which makes the JAMA piece published this week by ICER CMO David Rind all of the extra notable. Rind thought of Elevidys, Sarepta’s $3.2 million gene remedy for Duchenne muscular dystrophy. The therapy was given accelerated approval final yr for 4- and 5-year-olds and, after a Part 3 trial, the FDA is now contemplating whether or not to approve it for all ages.
That Part 3 trial missed its main endpoint, although, as did a earlier smaller research. Sarepta has pointed to the outcomes on secondary measures however given these information, Rind solid doubt on whether or not it must be accepted — and positively whether or not Sarepta ought to cost what different gene remedy corporations do. “This is a gigantic price ticket for a remedy that has failed to satisfy its main finish level within the 2 randomized trials by which it has been studied and that’s clearly not healing,” he wrote.
Amid a rocky yr for genomics, Illumina income on observe to remain flat
From STAT’s Jonathan Wosen: DNA sequencing juggernaut Illumina reported yesterday $1.06 billion in income for its core enterprise through the first quarter of this yr, down 2% from the identical time final yr, with the corporate’s execs reiterating that they count on 2024 income to basically match the $4.5 billion from the earlier fiscal yr.
CEO Jacob Thaysen cautiously described the first-quarter numbers as a “respectable begin to the yr” that exceeded expectations on a name with market analysts and traders. The up to date numbers come throughout a turbulent time for the broader sequencing area. Pacific Biosciences, a Bay Space firm that Illumina as soon as unsuccessfully tried to accumulate, not too long ago laid off almost 200 workers after reporting disappointing first-quarter gross sales. And whereas Illumina continues to manage about 80% of the market, its shares are down 37% from a yr in the past and the agency faces rising competitors from gamers corresponding to Ultima, Singular Genomics, and Ingredient Biosciences.
The San Diego genomics big remains to be on observe to finalize the phrases of its divestiture of Grail — a most cancers detection startup Illumina had acquired for $8 billion, drawing the ire of regulators within the U.S. and Europe — by the top of the second quarter of this yr.
Amgen goes all in on injectable weight problems drug
From STAT’s Elaine Chen: Amgen will scrap an early-stage weight problems capsule, and can as an alternative give attention to its extra superior injectable candidate known as MariTide that’s seen as a possible competitor to Wegovy and Zepbound.
MariTide is in a Part 2 trial for weight problems, and CEO Bob Bradway stated on the earnings name yesterday that “we’re very inspired with the outcomes” from an interim evaluation of that trial. The corporate is planning a “broad” Part 3 program that may research MariTide in weight problems, diabetes, and obesity-related circumstances, and it’s already gearing as much as make massive quantities of the drug, initiating actions “to additional broaden manufacturing capability with each scientific and industrial provide in thoughts,” Bradway stated.
MariTide has an attention-grabbing mechanism — it’s a monoclonal antibody linked to 2 peptides that prompts receptors of the GLP-1 hormone whereas blocking receptors of the GIP hormone. Although that seems to contradictory to the mechanism of Lilly’s potent weight problems drug Zepbound, which prompts each GLP-1 and GIP receptors, MariTide has proven potential to induce potent and longer-lasting weight reduction.
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Extra reads
- Biotech vets increase $67 million to develop focused activators for most cancers, Endpoints
- Regeneron’s blockbuster eye drug posts weaker gross sales resulting from stock affect, Reuters
