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Amgen, Illumina, Novo Nordisk and more

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Amgen, Illumina, Novo Nordisk and more

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Good morning! Especially today a crowdsourced Readout, with contributions from Jason Mast, Elaine Chen and Jonathan Wosen from STAT. We get revenue from Novo Nordisk, Amgen and Illumina, and see that ICER is not that enthusiastic about a gene therapy from Sarepta.

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CEO of Novo Nordisk defends Wegovy’s award, Ozempic

Novo Nordisk CEO Lars Fruergaard Jørgensen remains behind on Ozempic and Wegovy’s costs, despite an ongoing Senate investigation into the company’s prices. In an earnings call yesterday, he said the drugs offer “an attractive value proposition” because they are priced similarly to earlier, less effective versions of this class of drugs.

While he admitted that the number of people taking the drugs is “putting pressure on health care systems to some extent,” writes STAT’s Elaine Chen, the full value of these diabetes and obesity drugs has yet to be realized. Ozempic’s list price is $969 per month; Wegovy’s costs $1,349. Executives on the call said net prices for these drugs have already fallen, and will continue to do so as more people use them – and as competition increases.

Read more.

On the ethics of living brain research

The removal of small amounts of brain tissue from desperately ill patients, done as part of a research project at Mount Sinai, has raised alarm bells at the FDA and raised broader questions about the scientific and ethical justification for living brain research. Journalist and STAT contributor Katherine Eban joins “The Readout LOUD” this week to discuss the findings of a two-year investigation.

Also in this week’s episode, STAT’s Adam Feuerstein and Allison DeAngelis discuss Novartis’ attempt to acquire MorphoSys, and the latest news on Eli Lilly and Novo Nordisk’s blockbuster obesity drugs with Elaine Chen.

Listen.

ICER casts doubt on Sarepta’s DMD gene therapy

From STAT’s Jason Mast: The drug pricing watchdogs at the Institute for Clinical and Economic Review, or ICER, often take a dim view of modern drug pricing – except when it comes to gene therapy. These treatments, the nonprofit says, often provide the years-long benefits for serious diseases that justify a multimillion-dollar price tag.

That’s what JAMA makes part published this week by ICER CMO David Rind all the more remarkable. Rind was considering Elevidys, Sarepta’s $3.2 million gene therapy for Duchenne muscular dystrophy. The treatment received accelerated approval for 4- and 5-year-olds last year, and after a Phase 3 trial, the FDA is now considering whether to approve it for all ages.

However, that phase 3 study missed its primary endpoint, as did an earlier, smaller study. Sarepta has pointed to the results of secondary measures, but given that data, Rind has expressed doubts about whether it should be approved — and certainly whether Sarepta should charge for what other gene therapy companies are doing. “This is a huge price tag for a therapy that has failed to meet its primary endpoint in the two randomized trials in which the therapy has been examined, and is clearly not curative,” he wrote.

Amid a tough year for genomics, Illumina’s revenues remain on track to be flat

From STAT’s Jonathan Wosen: DNA sequencing juggernaut Illumina yesterday reported $1.06 billion in revenue for its core business during the first quarter of this year, down 2% from the same time last year, with company executives reiterating that they expect the revenues in 2024 will essentially match the $4.5 billion from the previous fiscal year.

CEO Jacob Thaysen cautiously described the first quarter figures as a “decent start to the year” that exceeded expectations during a call with market analysts and investors. The updated numbers come at a turbulent time for the broader sequencing space. Pacific Biosciences, a Bay Area company that Illumina once tried unsuccessfully to acquire, recently laid off nearly 200 employees after disappointing first-quarter sales. And while Illumina still has about 80% of the market, its shares are down 37% from a year ago and the company is facing increasing competition from players like Ultima, Singular Genomics and Element Biosciences.

The San Diego-based genomics giant is still on track to finalize terms for the divestiture of Grail — a cancer-detection startup that Illumina acquired for $8 billion, angering regulators in the U.S. and Europe — by the end of to complete the second quarter of this year. year.

Amgen goes all-in on injectable obesity drug

From Elaine Chen of STAT: Amgen will drop an early-stage obesity pill and instead focus on its more advanced injectable candidate called MariTide, which is seen as a potential competitor to Wegovy and Zepbound.

MariTide is in a Phase 2 study in obesity, and CEO Bob Bradway said on the earnings call yesterday that “we are very encouraged by the results” of an interim analysis of that study. The company is planning a “broad” Phase 3 program that will study MariTide in obesity, diabetes and obesity-related conditions, and is already gearing up to make large quantities of the drug, initiating activities “to further expand manufacturing capacity expanding with both clinical and commercial offerings in mind,” said Bradway.

MariTide has an interesting mechanism: it is a monoclonal antibody linked to two peptides that activates receptors of the GLP-1 hormone while blocking receptors of the GIP hormone. While that may seem at odds with the mechanism of Lilly’s powerful obesity drug Zepbound, which activates both GLP-1 and GIP receptors, MariTide has shown the potential to induce powerful and longer-lasting weight loss.

Read more.

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