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Welcome back to another edition of Endpoints Weekly! Fall is in full swing here in New York, with chilly temperatures and multicolored trees settling in. It’s a welcome respite from the muggy summer air for autumn enthusiasts like me!
We’ve got a crazy week to recap for you, with some of the biggest stories of the year continuing to unfold seemingly by the hour. The White House unveiled deals for GLP-1 drugs with Eli Lilly and Novo Nordisk, the Metsera buyout saga saw several punches and counterpunches, while one of Sarepta’s long-awaited confirmatory studies finally read out. Oh yeah, and there were also earnings this week!
If you aren’t signed up already for the Global Pharma and Biotech Summit with our cousins at the Financial Times, be sure to grab your passes, either in-person or virtual. The conference starts next Tuesday, Nov. 11, and will be held in London. Have a great weekend! — Max Gelman |
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Max Gelman |
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Senior Editor, Endpoints News |
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White House unveils deals with Eli Lilly, Novo Nordisk |
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🤝The Trump administration revealed discounts for blockbuster weight loss drugs this week in what HHS Secretary Robert F. Kennedy Jr. called “the most important of all the MFN announcements we’ve made.”
The details: Officials said the average monthly price of the companies’ GLP-1 products would be $350 per month via TrumpRx, which will be lowered to about $250 over two years. The price of Novo's injectable Wegovy and Ozempic will be $350 per month, while the average monthly price of Lilly's Zepbound, Mounjaro and future oral weight loss pill will be $346, Max Bayer reported. The initial dose of the oral versions, should they be approved, will be sold on TrumpRx at $149 per month.
Lilly announced separately that it will offer the lowest dose of its Zepbound multi-dose injectable pens for $299 per month for self-pay patients, with additional doses up to $449 per month. Lilly and Novo also agreed to offer MFN pricing on all new medicines they bring to market.
In exchange, Medicare will expand its coverage of the drugs to certain patients with obesity. Currently, GLP-1s are only covered by Medicare when they are prescribed for eligible conditions other than weight loss. Administration officials said that certain pre-existing conditions will still be tied to coverage depending on a patient's body mass index level, but patients with severe obesity alone will be eligible for weight loss coverage, Max reported. Lilly and Novo also get a three-year reprieve from tariffs.
Novo CEO Mike Doustdar said the deal could give the pharma company an edge against compounders. Novo and Lilly have filed dozens of lawsuits against pharmacies, med spas, weight loss clinics and telehealth companies selling
cheaper compounded versions of GLP-1s. “With the reduction of the price, hopefully many of these patients don’t need to choose their safety over their wallet and now are able to find the real thing at a very decent price,” Doustdar said at the White House.
Doustdar also commented on its bidding war with Pfizer for the obesity biotech Metsera. “Our message to Pfizer is that if they would like to buy the company, then put your hand in the pocket and bid higher,” he said. |
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Metsera saga ends |
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Metsera accepted Pfizer's bid, worth $10 billion in total, late on Friday night. Novo Nordisk said Saturday morning that it would not make a new offer.
A week ago, Pfizer had just filed a lawsuit against both companies, alleging anticompetitive behavior from Novo. In the days since, however, Pfizer and Novo each raised their earlier offers to at least $10 billion to try and clinch the deal. Novo actually raised its offer again on Thursday, but did not disclose the deal value during that attempt.
This has all happened despite the legal battle continuing to play out in real time. Pfizer filed a second suit in Delaware federal court. Metsera called Pfizer’s claims “nonsense.” Then, a judge ruled in favor of Metsera in the first case, denying Pfizer’s request for a temporary restraining order that would have prevented
Metsera from terminating the Pfizer buyout plan. At the same time, the FTC — which would need to sign off on any deal — expressed concerns over the structure of Novo’s bid.
Both companies also reported earnings this week. Novo Nordisk’s sales miss underlined its need to walk away from the situation with a Metsera acquisition, senior biopharma journalist Elizabeth Cairns writes.
As the story unfolded, we had you covered from every angle. Biotech correspondent Kyle LaHucik noted that everyone was talking about the deal at the ObesityWeek conference in Atlanta. Pfizer and Novo also made some personnel changes, which you can read about in our weekly Peer Review column. |
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Earnings updates |
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📊 Third-quarter earnings season continued this week, with reports coming in from several pharma companies. Here’s what happened:
- BioNTech raised its full-year guidance due to a windfall from its PD-1xVEGF bispecific collaboration with Bristol Myers Squibb.
- Pfizer disclosed 11 program cuts, including a Phase 3 sickle cell disease drug known as inclacumab and a Phase 2 MASH program.
- AstraZeneca reported record-breaking quarterly sales figures.
- Moderna’s third-quarter revenue was down 45% from the same period last year, as shrinking vaccine uptake and low RSV sales posed challenges.
- Madrigal Pharmaceuticals said it welcomes competition in the MASH space from Novo Nordisk.
- Teva CEO Richard Francis said IRA negotiations were “consistent with our midterm expectations.”
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Sarepta confirmatory study fails |
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Sarepta is no stranger to controversy. The company’s first product was approved in 2016 despite a negative advisory committee, and its confirmatory studies have taken years to complete. Sarepta faced problems earlier this year as well, when one of its products was pulled from the market and then returned.
But results came back for two of its drugs this week, and they weren't all that exciting: Two of its exon-skipping therapies for forms of Duchenne muscular dystrophy failed to meet their primary endpoint.
Nevertheless, Sarepta said it will seek a full approval from the FDA. The drugs, called Amondys 45 and Vyondys 53, were granted accelerated approvals in 2019 and 2021, respectively. Executives plan to argue that the confirmatory study showed “encouraging trends” and that the data were confounded by the Covid-19 pandemic. |
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China lifts import ban on Illumina sequencers |
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🧬China will reverse its ban on importing DNA sequencers from Illumina, the company said this week. During the ban — which was established in March — Illumina could sell reagents in China, but couldn’t sell the sequencers that drive most of its revenue, Jared Whitlock reported. China’s Ministry of Commerce said it would call off the import ban on Illumina and reverse restrictions on other companies after reaching a consensus during US-China trade talks in Kuala Lumpur. Read more in Jared’s story. |
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