Wall Street is mulling over critical data released last week Amgen's experimental weight-loss injection – a possible competitor within the blockbuster obesity drug market.
Some analysts said the early results of the trial's mid-stage appear positive overall. However, they noted that there remain questions on the drug's effectiveness and patient tolerance.
We likely won't get any further answers until the corporate releases the complete data from the study. These include results from a second a part of the study, which examines how long MariTide's weight reduction lasts.
Investors were initially not blissful. Shares of Amgen plunged greater than 11% on the market open last Tuesday as results appeared to fall barely in need of Wall Street's high expectations for the drug.
The MariTide injection helped patients with obesity lose as much as 20% of their weight on average after one 12 months without plateauing. Ahead of the information release, several analysts said they wanted MariTide to indicate a minimum of 20% weight reduction within the Phase 2 trial, with some hoping for as much as 25%.
Here is the comparison with the present injections in the marketplace based on recent studies:
- Novo Nordisk's Wegovy showed that it resulted in 15% weight reduction inside 68 weeks
- Eli Lilly's Zepbound helped patients lose greater than 22% of their weight inside 72 weeks
But in a note last week, Evan Seigerman, an analyst at BMO Capital Markets, said last Tuesday's stock response reflected “overly high expectations for percentage weight loss without any emphasis on easier dosing” of the shot.
Specifically, Amgen is testing MariTide as an injection given once a month and even less often, which can be much more convenient for patients to take long-term than Novo Nordisk and Eli Lilly's weekly injections.
“MariTide data clearly demonstrates that Amgen is a competitor in the obesity and diabetes indications and is today demonstrating compelling weight loss in both indications,” Seigerman said.
In the study, MariTide also helped patients with obesity and sort 2 diabetes lose as much as 17% of their weight after one 12 months.
The drug's effectiveness could also improve, Jefferies analyst Michael Yee said in a note last week. The 20% weight reduction after a 12 months with no plateau could increase to 25% by 18 months, Yee said. He found that, compared, Zepbound-induced weight reduction largely stagnated for a 12 months.
The most typical uncomfortable side effects of MariTide were gastrointestinal in nature, including nausea, vomiting, and constipation. Nausea and vomiting were predominantly mild and occurred in association with the primary dose of MariTide.
Amgen said the incidence of nausea and vomiting was also significantly reduced by increasing the dose. This involves starting patients on a lower dose of MariTide and regularly increasing it over a time period until they reach the next goal dose.
Approximately 11% of patients within the dose escalation groups discontinued treatment as a consequence of hostile uncomfortable side effects, while lower than 8% discontinued treatment specifically as a consequence of gastrointestinal uncomfortable side effects reminiscent of nausea and vomiting.
Amgen reported that 70% of patients in dose escalation groups experienced nausea and 40% experienced vomiting.
However, Amgen said it conducted one other early-stage study that found that when patients start MariTide, the starting dose was lower, these rates were significantly reduced, leading to about 50% of patients over Nausea and 20% reported vomiting.
This appears to be higher than the degrees of nausea and vomiting seen with Zepbound and Wegovy. Still, Seigerman said the low severity of those uncomfortable side effects and “the discrete events early in treatment make us confident that they are manageable.”
He added that he was “encouraged by the reductions observed with dose increases.”
In a research note last week, JPMorgan analyst Chris Schott said Amgen would examine lower starting doses in its Phase 3 trial of MariTide. The company believes that “further improvement in tolerability in the Ph3 trial will be key to potential acceptance of the compound,” he noted.
David Risinger, an analyst at Leerink Partners, outlined in a note last week key questions that may have to be addressed when the study's full results are released. He said this includes detailed data on how well patients tolerated the drug when no dose escalation was used, in addition to data on weight reduction in non-diabetic patients who received the very best dose of the drug.
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The latest in health tech: GE HealthCare acquires Japanese pharmaceutical company
GE Healthcare announced Monday that it’ll fully acquire Japanese radiopharmaceutical company Nihon Medi-Physics (NMP). GE HealthCare has held a 50% stake in the corporate since 2004 and can acquire the remaining half from Sumitomo Chemical, it said in a press release release.
Tokyo-based NMP was founded in 1973. The company makes radiopharmaceuticals, a special style of radioactive medicine that will be used to treat some sorts of cancer and perform imaging tests. NMP operates 13 manufacturing facilities and conducts its own research and development, GE HealthCare said.
Radiopharmaceuticals have gotten an increasingly competitive market as firms prefer it Bristol Myers Squibb, AstraZenecaEli Lilly and Novartis Race to develop them. Two Novartis radiopharmaceuticals, Pluvicto and Lutathera, are already available within the United States
According to the press release, NMP generated sales of roughly $183 million last 12 months. Prior to Monday's announcement, GE HealthCare held three seats on NMP's board.
“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,” said Kevin O'Neill, president and CEO of GE's Pharmaceutical Diagnostics segment HealthCare, the press release says.
Terms of the deal weren’t disclosed and shutting is anticipated to shut early next 12 months, in line with the press release. The takeover remains to be subject to official approval.
Solomon Partners advised GE HealthCare on the transaction.
GE HealthCare announced the acquisition in the course of the Radiological Society of North America's 2024 Annual Meeting in Chicago, where it shared various additional updates. This week the corporate introduced a brand new one 3D MRI Research foundation model, a recent SPECT/CT solution and a recent template including the US Food and Drug Administration.
Read the complete press release about GE HealthCare's acquisition of NMP Here.
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