Amgen, newer rivals could threaten Novo Nordisk and Eli Lilly’s weight loss drug dominance 

Weight loss injectable drug Vegovy is available at New City Halsted Pharmacy in Chicago, Illinois on April 24, 2024.

Scott Olson | getty images

Novo Nordisk And Eli Lilly Dominating fast growing people for a long time weight loss medicine marketBut their monopoly is closer than ever to facing threat from a new rival.

amgen One of the leaders of a group of drug manufacturers racing to join the market with their own weight loss treatments. as a company pushes forward With the trials needed to bring its experimental obesity injection to market in the coming years, it could some benefits,

Amgen’s drug, Meritide, is taken less frequently than Novo Nordisk’s Vegovy and Eli Lilly’s Zepbound, and can lead to longer-term weight loss than the market leaders’ injections. Amgen, one of the country’s largest pharmaceutical companies, can also produce drugs on a large scale — a huge advantage over smaller biotech companies that lack a large manufacturing footprint.

“Many other people are also trying to get in [the market] Both small and large, but when I step back, I think Amgen has a real opportunity to be disruptive and challenge Eli Lilly and Novo,” William Blair & Co. analyst Matt Phipps told CNBC.

Amgen has seen it share pop CEO Bob Bradley said Thursday that 12% said he was “very encouraged” by the ongoing mid-stage study on MarineTide. But it’s not the only company that has a chance to upend the market.

Viking Therapeutics, all immune, structure therapeutics, AstraZeneca and partners Boehringer Ingelheim and Zeeland PharmaOthers, among others, are making encouraging progress on their own treatments. Novo Nordisk and Eli Lilly are working on new weight loss medicinesToo.

“I don’t know if I’m ready to pick another clear winner based on the data we have,” Phipps said.

Competition for a share of the weight loss market has become more fierce in recent months. Still, despite intermittent supply shortages and limited insurance coverage, demand for Wegovi and Zepbound is not expected to slow down any time soon – with room for new entrants in the segment expected to grow. $100 billion By the end of the decade.

While Amgen is in a strong position, it will take years for Maritide to reach patients. The company has not provided an estimated launch date for its obesity injection. In a research note Thursday, JPMorgan analyst Chris Schott estimated it would hit the market in 2028.

Amgen appears to have a competitive edge

Amgen is testing taking its drug once a month or less, which would be more convenient than the weekly drugs available on the market. Many drugmakers are developing weekly injections or daily pills, but some have not ruled out testing lower doses for their drugs.

Maritide showed sustained weight loss That’s followed by a single injection or multiple shots during Phase 1 trials, allowing lower doses of the drug, according to the study authors. The company’s drug may last longer in the body than existing treatments, the authors said.

The Amgen logo is displayed outside the Amgen headquarters in Thousand Oaks, California on May 17, 2023.

Mario Tama | getty images

Phipps said he believes patients can take Meritide less frequently, such as once a quarter, to maintain the weight loss seen after starting the drug. That could make it easier for Amgen to manufacture enough supplies of the treatment — and avoid the problem that has plagued Novo Nordisk and Eli Lilly.

Amgen is already beginning to expand manufacturing capacity for Maritide, executives said during an earnings call last week.

Phipps said lower doses of Meritide may have fewer side effects than other weight loss treatments. Many patients stop taking existing medications due to nausea and vomiting.

Maritide causes some of the same side effects, but Phipps said monthly or quarterly injections of the drug will result in fewer days of feeling sick than weekly dosing. He said this could help patients continue treatment and lose weight.

“Even if you have some nausea a day, but once a week versus only once a quarter, I think that’s a huge deal for enrolling more patients,” Phipps said.

Like Wegovi and Zepbound, Amgen’s treatment activates a gut hormone receptor called GLP-1 to help control a person’s appetite.

But when Zepbound activates a second hormone receptor called GIP, Amgen’s drug blocks it. Wegovi does not target GIP, which suppresses appetite, like GLP-1, but it may also improve how the body breaks down sugar and fat.

While Amgen’s progress has excited Wall Street and sent its stock soaring, several other companies are also making progress in bringing products to market. That’s where those other medications stand.

New Novo Nordisk, Eli Lilly drugs are on the way

An injection pen of Eli Lilly’s weight loss drug Zepbound is displayed in New York City, US on December 11, 2023.

Brendan McDiarmid | reuters

Meanwhile, Eli Lilly is studying an experimental drug called retatrutide In the final phase of testing. That treatment helped patients lose up to 24% of their weight after about a year in a mid-stage trial, setting a new standard for weight loss.

Rettrutide mimics three different appetite-regulating hormones: GLP-1, GIP, and glucagon. This combination appears to be even more effective in controlling a person’s appetite.

Eli Lilly is also developing an oral drug called orforgaliprone, which targets GLP-1. The company is scheduled to release late-stage trial data on the pill and retreptide in 2025.

Boehringer Ingelheim, Zeeland Pharma Injection

Among other potential entrants, Boehringer Ingelheim and Danish biotech firm Zeeland Pharma developing a weekly weight loss Injection. The experimental drug works by targeting GLP-1 to suppress appetite and glucagon to increase energy expenditure.

Boehringer Ingelheim said in August it was advancing a drug called cervodutide final phase study, Mid-stage trials in patients who are overweight or obese 19% of their weight After 46 weeks of treatment with the drug.

In February, the companies also posted positive mid-stage trial data on cervodutide in patients with severe liver disease.

Boehringer Ingelheim expects cervoduitide to launch As a treatment for obesity or liver disease in 2027 or 2028, as long as trial data is favorable, according to a Reuters interview.

AstraZeneca and Pfizer pills

AstraZeneca is also developing a daily obesity pill, called ECC5004 this partnership Agreement with Chinese biotech company Accogene in November.

AstraZeneca officials have said the pill is absorbed rapidly And does not last long in the stomach, which may reduce side effects compared to existing treatments. Executives also said patients could take the pill alone or in combination with other oral medications, such as the diabetes drug Farxiga, to treat obesity and related health problems.

But the drug, which targets GLP-1, is years away from coming to market. The company has completed a Phase 1 trial in diabetic patients and plans to present data at a medical conference later this year, executives said during an earnings call in April.

Also in early-stage testing is AstraZeneca’s experimental obesity drug AZD6234, which targets another gut hormone called amylin. company hope it can combine AstraZeneca CEO Pascal Soriot said in November that AZD6234, along with its oral GLP-1, would help patients achieve greater weight loss than existing drugs.

Outside AstraZeneca’s Macclesfield factory.

Christopher Furlong Getty Images News | getty images

Meanwhile, investors are eager to see new data on Pfizer’s once-daily obesity pill around the middle of the year, which will determine the company’s fate in the weight-loss drug market. company finished off That pill, danuglipron, used twice a day, was discontinued in December after patients had difficulty tolerating it during a trial.

Pfizer may have another opportunity to enter the market if it acquires a small obesity drug maker. But for now, dealmaking seems unlikely as the company works to recover from the decline in its Covid business last year.

“As it relates to bolt-on acquisitions, you wouldn’t expect us to do much there in the near term,” Pfizer CFO David Denton said during an earnings call last week.

Small biotechs look promising

In addition to those major pharmaceutical companies, Viking Therapeutics, Ultimmune, and Structure Therapeutics have attracted immense attention for their respective weight loss drug pipelines. All three have far fewer resources and less manufacturing capacity than Amgen or Pfizer, but the situation could change if they were bought by a larger drugmaker.

Viking Therapeutics released in March initial data From mid-stage testing of its experimental injection, which targets GLP-1 and GIP. Those who received weekly doses of the treatment lost 13.1% of their weight after 13 weeks, compared with patients who received a placebo.

Company CEO Brian Lian said during an investor call in March that Viking would likely conduct a Phase 2 trial that could last six to nine months. Jefferies analyst Akash Tiwari wrote in a note the same month that Viking’s treatment would not reach the market until 2029 or later.

Also in March, Viking said it planned to begin a Phase 2 trial of its drug after its oral version was shown positive results In a small study.

Structure Therapeutics is also developing an oral GLP-1 for obesity and diabetes. But it missed Wall Street’s expectations by weighing in on a mid-stage trial in December.

This pill helped obese patients to lose weight roughly 5% After eight weeks their weight increased compared to those who received a placebo.

Structure said it expects to have full 12-week results in obese patients in the second quarter of this year. The company plans to begin a larger mid-stage study in the second half of this year and a late-stage trial in 2026.

Ultimune is developing a weekly obesity injection called pemvidutide, which targets GLP-1 and glucagon.

In November, Altimune released mid-stage trial data that showed its drug led to an average weight loss of 15.6% after 48 weeks. The company also announced additional data from a study in March that showed its injection minimize damage of muscle mass, a negative side effect of existing weight loss injections.

Altimmune will meet with the Food and Drug Administration in the second half of the year to determine the path forward for the injection.