August 3, 2023

The need-to-know this morning

Regeneron Pharmaceuticals offered a regulatory update on the 8 mg dose of its ocular treatment Eylea, which was rejected by the FDA in June because of unresolved issues with its manufacturing partner Catalent. Today, Regeneron said information requested by the FDA will be submitted in "mid-August" and it expects an FDA decision in the current quarter. It also warned that the agency's review could be extended by another three months. Regeneron reported second-quarter earnings and revenue that exceeded Wall Street estimates.
Moderna reported a smaller-than-expected loss on higher revenue in the second quarter. The company reiterated expectations for $6 billion-$8 billion in Covid-19 vaccine sales this year, with the range mostly dependent on U.S. vaccination rates in the fall.
Alnylam Pharmaceuticals reported a larger-than-expected loss in the second quarter on lighter revenue. The company reaffirmed previous 2023 product sales guidance in the range of $1.2 billion to $1.285 billion.

Biotech

Third Rock startup Celsius cuts 75% of staff to conserve cash

Celsius Therapeutics, an immunology startup launched in 2018 by Third Rock Ventures, has laid off the majority of its staff and slashed its pipeline, an effort to cut costs as the firm moves forward with its first clinical trial.

As STAT's Allison DeAngelis reports, Celsius cut 75% of its 40-person payroll and shut down nearly all of its early-stage research projects. The company is prioritizing its lead drug, a treatment for inflammatory bowel disease, which is entering Phase 1 testing.

Celsius last raised money in 2022, getting $50 million in venture capital and another $33 million in loans. Efforts to raise a Series C fell apart due to disagreements over the company's valuation, and the tepid market for biotech IPOs made going public untenable, Celsius said.

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R&D

Vertex's pain drug could fill a billion-dollar demand

Vertex Pharmaceuticals' non-opioid pain treatment met its goals in a pair of randomized clinical trials, showing a small but statistically significant treatment effect that could make it a desirable alternative to habit-forming painkillers.

As STAT's Jonathan Wosen reports, the data, published in the New England Journal of Medicine, come from two trials enrolling nearly 600 patients recovering from bunion surgery or abdominoplasty. Patients received either Vertex's drug, placebo, or a combination of acetaminophen and hydrocodone.

In the coming months, Vertex is expecting data from two Phase 3 studies that will determine whether its drug, VX-548, can win regulatory approval. If everything goes well, Vertex could control a fifth of the prescription painkiller market by 2032, according to analysts at Leerink Partners, pulling in peak annual revenue of $4.8 billion.

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GLP-1

Insurers are going to war over Wegovy

The explosion of demand for novel weight-loss drugs has led to a crackdown on the part of insurance companies, putting pressure on prescribers and worrying the many patients who have come to rely on the medicines.

As STAT's Elaine Chen reports, only Novo Nordisk's Wegovy is approved as a treatment for obesity, but doctors have been writing off-label prescriptions for Ozempic and Eli Lilly's Mounjaro, each approved for diabetes, to patients who don't have diabetes but have obesity and weight-related health concerns. That practice, which is legal, has led some insurers to send threatening letters to physicians.

"They're trying to dampen and make prescribers stop and think and be, 'Oh, am I going to lose my license over this?'" said Cate Varney, the obesity medicine director at the University of Virginia Health System. "They're trying to give them pause because they are going to bleed money and it's going to cut into their profits."

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Washington

Pharma is suddenly enamored with a rank-and-file House Republican

Rep. Larry Bucshon, an Indiana Republican, isn't a household name, doesn't lead any powerful committees, and isn't facing a high-stakes re-election campaign. But for whatever reason, he's a big hit with Big Pharma.

As STAT's Rachel Cohrs reports, drug company CEOs, PhRMA executives, and corporate political action committees all gave in higher-than-usual numbers to Bucshon in the last quarter. That included the CEOs of Pfizer, Eli Lilly, and Biogen, plus the PACs of Novartis, Bayer, and Takeda. Bucshon received $56,000 in pharma cash between April 14 and June 30.

Bucshon has hardly been a firebrand on the issue of drug pricing, but he did oppose the Inflation Reduction Act, arguing in a tweet that allowing Medicare to negotiate with drug companies "will lead to higher prices and fewer cures for Hoosiers."

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