• by Les Luchter , November 27, 2024

Just in time for the potential weight gains of Thanksgiving weekend, pharma’s Amgen on Tuesday unveiled impressive results for its budding obesity drug MariTide: for participants, up to 20% average weight loss after 52 weeks of trial, with an expectation of further loss after that period.

Unlike such competitors as Novo Nordisk’s Wegovy/Ozempic and Eli Lilly’s Zepbound/Mounjaro, this potential category killer is injected once a month rather than weekly. MariTide has also been proven effective on an every-two-months basis and will soon be studied as a quarterly regimen, the company noted in a rare non-earnings related call with analysts that followed its announcement.

Other differences shown versus established GLP-1 drugs included the lack of a yo-yo effect, in which weight lost is gained back once patients stop taking the medication, according to Bob Bradway, Amgen chairman and chief executive officer.

“When doses were stopped, many patients retained the benefit of weight loss that they enjoyed from the medicine,” explained  Jay Bradner, Amgen’s chief scientific officer and executive vice president, research and development “Weight loss remained progressive and did not plateau” as doses were increased,” he added.

The lack of the yo-yo effect helps explain how Amgen is moving to space doses further and further apart from each other, a clear distinction from the weekly doses of others.

Calling MariTide an “important breakthrough,” Susan Sweeney, Amgen’s executive vice president obesity and related conditions, said that beyond obesity and type 2 diabetes, the drug will also be studied for treatment of such conditions as kidney disease, cardiovascular disease, obstructive sleep apnea and heart failure.

"The drug still must go through additional clinical trial phases involving many more patients, and then receive approval from the Food and Drug Administration before being sold to patients," according to The New York Times. "The company has yet to set a price for the drug and did not lay out a timeline for when the drug may become available."

The analysts call ended in time for the opening of the stock market, which didn’t find Amgen’s findings to its liking, as the company’ stock proceeded to drop 4.8%.  MariTide’s 20% weight loss figure was no higher than Zepbound’s and had a higher level of side effects, analysts told Investors Business Daily. Furthermore, the publication reported, another pipeline drug, from  Viking Therapeutics, had achieved 14.7% weight loss after only 13 weeks.

Meanwhile, stock prices for Novo Nordisk and Eli Lilly both rose, which may have more to do with a proposal announced Tuesday by the U.S. Centers for Medicare & Medicaid Services (CMS) than to the news out of Amgen.

That proposal calls for Medicare and Medicaid programs to start covering obesity drugs, but the final outcome is far from assured. Larry Levitt, executive vice president for health policy at the KFF nonprofit, told NBC News that while Dr. Mehmet Oz, Donald Trump’s nominee to head CMS, has praised obesity drugs, Robert F. Kennedy Jr., his nominee to head Health & Human Services, which runs CMS, has been skeptical of them.

In another, unrelated, proposal, the outgoing CMS called for expansion of the Centers’ oversight of Medical Advantage advertising. Under new rules implemented last year, which barred such practices as showing Medicare cards onscreen, using the Medicare name misleadingly, and providing toll-free hot line numbers other than that of the nonprofit Medicare Rights Center, CNS reported that it had prohibited over 1,500 TV ads from being aired.