Wall Street mulls over Amgen weight reduction drug data

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Wall Street is chewing over critical data released last week on Amgen’s experimental weight reduction injection – a possible competitor within the blockbuster obesity drug market. 

Some analysts said the initial mid-stage trial results appear positive overall. But questions remain in regards to the drug’s efficacy and the way well patients tolerate it, they noted. 

We likely won’t get more answers until the corporate releases the complete data from the study. That features results from a second a part of the trial, which examines how long MariTide’s weight reduction lasts. 

Investors initially weren’t pleased. Shares of Amgen tumbled greater than 11% because the markets opened last Tuesday, as the outcomes seemed to be barely below Wall Street’s lofty expectations for the drug.

The injection, MariTide, helped patients with obesity lose as much as 20% of their weight on average after a 12 months, with no plateau. Ahead of the information, several analysts said they wanted MariTide to indicate weight reduction of no less than 20% within the phase two trial, with some hoping for as much as 25%. 

Here’s how that compares to the prevailing injections in the marketplace, based on late-stage studies:

• Novo Nordisk‘s Wegovy showed that it led to fifteen% weight reduction over 68 weeks 
• Eli Lilly‘s Zepbound helped patients lose greater than 22% of their weight over 72 weeks

But in a note last week, BMO Capital Markets analyst Evan Seigerman said the stock response last Tuesday reflects “too-high expectations for % weight reduction, without assigning value to easier dosing” of the injection. 

Notably, Amgen is testing MariTide as an injection taken once a month and even less regularly, which could be much more convenient for patients to take long run than the weekly injections from Novo Nordisk and Eli Lilly. 

“MariTide data firmly establishes Amgen as a competitor in obesity and diabetes indications, today showing compelling weight reduction in each indications,” Seigerman said. 

Within the trial, MariTide also helped patients with obesity and Type 2 diabetes lose as much as 17% of their weight after a 12 months.

The drug’s efficacy can also improve, Jefferies analyst Michael Yee said in a note last week. The 20% weight reduction after one 12 months, with no plateau, may increase to 25% by 18 months, Yee said. He noted that compared, the burden loss attributable to Zepbound mostly plateaued by a 12 months. 

Essentially the most common uncomfortable side effects for MariTide were gastrointestinal, including nausea, vomiting and constipation. Nausea and vomiting were mainly mild and related to the primary dose of MariTide. 

Amgen said incidences of nausea and vomiting were also significantly reduced with dose escalation, which refers to starting patients at a lower dose of MariTide and progressively increasing it over a particular time period until they reach the next goal dose. 

Roughly 11% of patients in groups with dose escalation discontinued treatment due to any antagonistic uncomfortable side effects, while lower than 8% stopped specifically as a result of gastrointestinal uncomfortable side effects equivalent to nausea and vomiting. 

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

Nevertheless, Amgen said it conducted one other early-stage study that found starting patients with lower initial doses of MariTide cut those rates substantially, resulting in about 50% of patients reporting nausea and 20% reporting vomiting. 

That appears to be higher than the degrees of nausea and vomiting seen for Zepbound and Wegovy. Still, Seigerman said the mild severity of those uncomfortable side effects and “isolated time of events initially of treatment give us confidence they may be managed.” 

He added that he’s “encouraged by the reductions seen with dose escalations.” 

In a research note last week, JPMorgan analyst Chris Schott said Amgen will explore lower starting doses in its phase three trial on MariTide. The firm believes that “further improved tolerability within the Ph3 trial shall be key to potential uptake for the asset,” he noted. 

Leerink Partners analyst David Risinger, in a note last week, outlined key questions that need clarification when full results from the trial are released. He said that features detailed data on how well patients tolerated the drug when dose escalation wasn’t used, and weight reduction data amongst non-diabetic patients that received the best dose of the drug. 

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GE HealthCare on Monday announced it would fully acquire the Japanese radiopharmaceutical company Nihon Medi-Physics (NMP). GE HealthCare has held a 50% stake in the corporate since 2004, and it would purchase the remaining half from Sumitomo Chemical, in keeping with a release.

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

Radiopharmaceuticals have gotten an increasingly competitive market, as firms like Bristol Myers Squibb, AstraZeneca, Eli Lilly and Novartis race to develop them. Two radiopharmaceuticals from Novartis, Pluvicto and Lutathera, are already available within the U.S.

NMP generated around $183 million in revenue last 12 months, in keeping with the discharge. Prior to Monday’s announcement, GE HealthCare held three seats on NMP’s board of directors.  

“This may strengthen our precision care strategy in Asia and our existing footprint in Japan, where our contrast media and medical devices are used every single day to enable imaging procedures across the country,” Kevin O’Neill, president & CEO of the Pharmaceutical Diagnostics segment of GE HealthCare, said in the discharge.

The terms of the deal weren’t disclosed, and it is predicted to shut early next 12 months, in keeping with the discharge. The acquisition continues to be subject to regulatory approval. 

Solomon Partners advised GE HealthCare on the transaction. 

GE HealthCare announced the acquisition through the Radiological Society of North America’s 2024 annual meeting in Chicago, where it has shared a variety of additional updates. This week, the corporate has unveiled a recent 3D MRI research foundation model, a recent ​​SPECT/CT solution and a recent submission to the U.S. Food and Drug Administration, amongst other things.

Read the complete release about GE HealthCare’s acquisition of NMP here.

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