Wall Street mulls data on weight-loss drug Amgen

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health care news straight to your inbox. Subscribe here to receive future editions.

Wall Street reflects on critical data released last week on Amgen’Its experimental weight loss injection – a potential competitor in the blockbuster obesity drug market.

Some analysts have said early results from the mid-term trials appear generally positive. But questions remain about the drug’s effectiveness and how patients tolerate it, they noted.

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

At first, investors weren’t happy. Amgen shares fell more than 11% as markets opened last Tuesday, with results appearing slightly below Wall Street’s high expectations for the drug.

The injection, MariTide, helped obese patients lose up to 20% of their weight on average after one 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 hoping for as much as 25%.

Here’s how it compares to existing injections on the market, based on advanced studies:

• Novo NordiskWegovy’s showed it resulted in 15% weight loss over 68 weeks
• Elie LillyZepbound’s 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 last Tuesday’s stock market reaction reflected “too high expectations in terms of weight loss percentage, without assigning a value to a dosage easier” of the injection.

Amgen is notably testing MariTide as an injection taken once a month, or even less frequently, which would be much more convenient for patients to take long term than the weekly injections of Novo Nordisk and Eli Lilly.

“MariTide data firmly establishes Amgen as a competitor in obesity and diabetes indications, today showing 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 effectiveness could also improve, Jefferies analyst Michael Yee said in a note last week. The 20% weight loss after a year, with no plateau, could reach 25% by 18 months, Yee said. He noted that in comparison, the weight loss caused by Zepbound largely stabilized after a year.

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

Amgen said the incidences of nausea and vomiting were also significantly reduced with increasing dose, which means starting patients with a lower dose of MariTide and gradually increasing it over a specific period of time until until they reach a higher target dose.

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

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

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

This appears to be higher than the levels of nausea and vomiting seen for Zepbound and Wegovy. Still, Seigerman said the mild severity of these side effects and “the isolated time of events early in treatment gives us confidence that they can be managed.”

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

In a research note last week, JPMorgan analyst Chris Schott said Amgen would explore lower starting doses in its phase three trial of MariTide. The company believes that “further improved tolerability in the Ph3 trial will be key to the potential adoption of this asset,” he noted.

Leerink Partners analyst David Risinger outlined key questions in a note last week that will need clarification when the full results of the trial are released. He said this includes detailed data on how patients tolerated the drug when dose escalation was not used, as well as data on weight loss in non-diabetic patients who received the highest dose of the drug.

Feel free to send tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

GE Health announced Monday the full acquisition of Japanese radiopharmaceutical company Nihon Medi-Physics (NMP). GE HealthCare has held a 50% stake in the company since 2004 and will purchase the remaining half from Sumitomo Chemical, according to a release.

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

Radiopharmaceuticals are becoming an increasingly competitive market, as companies like Bristol Myers Squibb, AstraZenecaEli Lilly and Novartis race to develop them. Two Novartis radiopharmaceuticals, Pluvicto and Lutathera, are already available in the United States

NMP generated approximately $183 million in revenue last year, according to the release. 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 existing presence in Japan, where our contrast agents and medical devices are used daily to enable imaging procedures across the country,” Kevin O’Neill, president and CEO of the Pharmaceutical Diagnostics segment. of GE HealthCare, said in the release.

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

Solomon Partners advised GE HealthCare on the transaction.

GE HealthCare announced the acquisition at the 2024 Radiological Society of North America Annual Meeting in Chicago, where it shared a number of additional updates. This week, the company unveiled, among other things, a new 3D MRI research base model, a new SPECT/CT solution and a new submission to the U.S. Food and Drug Administration.

Read the full release on GE HealthCare’s acquisition of NMP here.

Feel free to send tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.