Wall Street mulls data on weight-loss drug Amgen

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Wall Street is analyzing critical data released last week on amgen's experimental weight-loss injection: a potential competitor in the successful obesity drug market.

Some analysts said the initial midterm test results appear positive overall. But questions remain about the drug's effectiveness and how well patients tolerate it, they noted.

We probably won't get more answers until the company releases the full data from the study. That includes results from a second part of the trial, which examines how long MariTide's weight loss lasts.

At first investors were not happy. Amgen shares fell more than 11% when markets opened last Tuesday, as results appeared to fall slightly short of Wall Street's lofty expectations for the drug.

The injection, MariTide, helped obese patients lose up to 20% of their weight on average after a year, without plateauing. Ahead of the data, several analysts said they wanted MariTide to show at least 20% weight loss in the phase two trial, with some expecting as much as 25%.

Here's how it compares to existing injections on the market, according to late-stage studies:

• NordiskWegovy showed that it led to a 15% weight loss in 68 weeks.
• Eli LillyZepbound helped patients lose more than 22% of their weight in 72 weeks

But in a note last week, BMO Capital Markets analyst Evan Seigerman said the stock's reaction last Tuesday reflects “overly high expectations for percent weight loss, without assigning value to easier dosing.” of the injection.

In particular, Amgen is testing MariTide as an injection given once a month or even less frequently, which would be much more convenient for long-term patients than weekly injections from Novo Nordisk and Eli Lilly.

“MariTide's data firmly establishes Amgen as a competitor in obesity and diabetes indications, and today shows compelling weight loss in both indications,” Seigerman said.

In the trial, MariTide also helped patients with obesity and type 2 diabetes lose up to 17% of their weight after one year.

The drug's efficacy may also improve, Jefferies analyst Michael Yee said in a note last week. Weight loss of 20 percent after one year, without plateauing, can increase to 25 percent at 18 months, Yee said. He noted that, by comparison, the weight loss caused by Zepbound mostly plateaued after a year.

The most common side effects of MariTide were gastrointestinal, including nausea, vomiting, and constipation. Nausea and vomiting were primarily mild and associated with the first dose of MariTide.

Amgen said the incidence of nausea and vomiting was also significantly reduced with dose escalation, which refers to starting patients on a lower dose of MariTide and gradually increasing it over a specific period of time until they reach a target dose. higher.

Approximately 11% of patients in the dose escalation groups discontinued treatment due to any adverse side effects, while less than 8% specifically discontinued due to gastrointestinal side effects such as nausea and vomiting.

Amgen reported that 70% of patients in the dose-escalation groups experienced nausea and 40% vomited.

However, Amgen said it conducted another early-stage study that found that starting patients on lower starting doses of MariTide reduced those rates substantially, leading to about 50% of patients reporting nausea and 20% reporting vomiting.

That appears to be higher than the levels of nausea and vomiting seen in Zepbound and Wegovy. Still, Seigerman said the mild severity of those side effects and “the isolated timing of the events at the start of treatment give us confidence that they can be controlled.”

He added that he is “encouraged by the reductions seen with increasing doses.”

In a research note last week, JPMorgan analyst Chris Schott said Amgen will explore lower starting doses in its phase three trial with MariTide. The firm believes that “greater tolerability in the Ph3 trial will be key to possible acceptance of the asset,” he noted.

Leerink Partners analyst David Risinger, in a note last week, outlined key questions that will need clarification when full trial results are released. He said that includes detailed data on how well patients tolerated the drug when no dose escalation was used, and weight loss data among nondiabetic patients who received the highest dose of the drug.

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GE Health Care announced on Monday that it will fully acquire Japanese radiopharmaceutical company Nihon Medi-Physics (NMP). GE HealthCare has owned a 50% stake in the company since 2004 and will buy the remaining half from Sumitomo Chemical, according to a statement.

Tokyo-based NMP was founded in 1973. The company makes radiopharmaceuticals, a special type of radioactive drug that can be used to treat some cancers and perform imaging tests. NMP manages 13 manufacturing facilities and the company conducts its own related research and development, GE HealthCare said.

Radiopharmaceuticals are becoming an increasingly competitive market, as companies such as Bristol-Myers Squibb, AstraZenecaEli Lilly and Novartis race to develop them. Two radiopharmaceuticals from Novartis, Pluvicto and Lutathera, are now available in the US.

NMP generated about $183 million in revenue last year, according to the statement. Prior to Monday's announcement, GE HealthCare held three seats on NMP's board of directors.

“This will strengthen our precision care strategy in Asia and our current presence in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country,” Kevin O'Neill, President and CEO Executive of the Pharmaceutical Diagnostics segment. of GE HealthCare, said in the statement.

Terms of the deal were not disclosed and it is expected to close early next year, according to the statement. The acquisition is still subject to regulatory approval.

Solomon Partners advised GE HealthCare on the transaction.

GE HealthCare announced the acquisition during the Radiological Society of North America's 2024 annual meeting in Chicago, where it shared a number of additional updates. This week, the company has unveiled a new basic 3D MRI research model, a new SPECT/CT solution, and a new submission to the US Food and Drug Administration, among other things.

Read the full statement on GE HealthCare's acquisition of NMP here.

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