December 26, 2024

The injectable weight loss drug Wegovy will be available at New City Halstead Pharmacy in Chicago, Illinois on April 24, 2024.

Scott Olson | Getty Images

Novo Nordisk and Eli Lilly and Company The duopoly has long dominated the fast-growing weight-loss drug market, but their duopoly is closer than ever to being threatened by new competitors.

Amgen is among a number of drugmakers racing to bring their own weight-loss treatments to market. As the company advances the trials needed to bring its experimental obesity injection to market over the next few years, it may have some advantages.

Amgen’s drug MariTide is taken less frequently than Novo Nordisk’s Wegovy and Eli Lilly and Company’s Zepbound and may lead to longer-lasting weight loss results than the market leader’s injections. Amgen, one of the largest pharmaceutical companies in the United States, can also produce drugs at scale — a huge advantage over smaller biotech companies that lack the scale to produce large-scale products.

William Blair said: “There are many other companies trying to break into (the market), both large and small, but when I step back, I do think Amgen does have an opportunity to disrupt and challenge Eli Lilly and Novo.

Amgen shares have risen 12% since Chief Executive Bob Bradley said Thursday that ongoing mid-stage studies on MariTide were “very encouraging.” But it’s not the only company with a chance to disrupt the market.

Viking therapy, All immune, structural therapy, AstraZeneca Partners such as Boehringer Ingelheim and Sealand Pharmaceuticals are making encouraging progress with their respective treatments. Novo Nordisk and Eli Lilly and Company are also working on new weight-loss drugs.

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

Competition for weight loss market share has become more intense in recent months.Still, despite intermittent supply shortages and limited insurance coverage, demand for Wegovy and Zepbound isn’t expected to slow down anytime soon – setting the stage for an expected growth to $100 billion by the end of this century.

While Amgen is in a strong position, MariTide will take years to reach patients. The company has not yet provided an expected launch date for the obesity shot. JPMorgan analyst Chris Schott estimated in a research note on Thursday that the product would be available in 2028.

Amgen appears to have competitive advantage

Amgen is testing taking its drug once a month or even less frequently, which would be more convenient than the weekly drugs on the market. Some drug companies are developing drugs that can be injected weekly or taken daily, but some have not ruled out testing less frequent doses.

MariTide show In the phase 1 trial, weight loss was sustained after either a single injection or multiple injections, allowing the drug to be taken less frequently, the study authors said. The company’s drug also stays in the body much longer than current treatments, the authors said.

On May 17, 2023, the Amgen logo was displayed outside the Amgen headquarters in Thousand Oaks, California.

Mario Tama | Getty Images

Phipps said he believes patients could take MariTide less frequently, such as once a quarter, to maintain weight loss after starting the drug. That could make it easier for Amgen to produce enough treatments and avoid the problems that have plagued Novo Nordisk and Eli Lilly.

Amgen executives said on an earnings call last week that Amgen has begun expanding MariTide production capacity.

Phipps noted that lower doses of MariTide may produce fewer side effects than other weight loss treatments. Many patients stop taking their current medications because of nausea and vomiting.

MariTide causes some of the same side effects, but Phipps said monthly or quarterly injections of the drug result in fewer days of discomfort than weekly injections. This can help patients continue treatment and maintain weight loss, he said.

“Even if you do feel a little nauseous throughout the day, doing it once a quarter instead of once a week, I think is really important in keeping more patients on treatment,” Phipps said.

Much like Wegovy and Zepbound, Amgen’s treatment activates a gut hormone receptor called GLP-1 to help regulate appetite in humans.

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

While Amgen’s progress has excited Wall Street and sent its stock price climbing, a range of other companies have also made progress in bringing products to market. This is the case with other drugs.

New drugs from Novo Nordisk and Eli Lilly coming soon

The injection pen of Eli Lilly and Company’s weight loss drug Zepbound is on display in New York City, the United States, on December 11, 2023.

Brendan McDermid | Reuters

Meanwhile, Eli Lilly is studying an experimental drug called retarglutide in late-stage trials. After nearly a year of mid-term trials, the treatment helped patients lose 24% of their body weight, setting a new standard for weight loss.

Retarglutide mimics three different hunger-regulating hormones: GLP-1, GIP, and glucagon. This combination appears to be more effective at suppressing a person’s appetite.

Eli Lilly is also developing an oral drug called orforglipron, which targets GLP-1. The company plans to release late-stage trial data for this drug and retarglutide in 2025.

Boehringer Ingelheim, Xilan Pharmaceutical Injection

Among other potential entrants, Boehringer Ingelheim and Danish Biotech New Zealand pharmaceutical company is developing weekly lose weight injection. This experimental drug increases energy expenditure by suppressing appetite and glucagon by targeting GLP-1.

Boehringer Ingelheim said in August it was moving the drug, called survodutide, into a single drug. Later research.A mid-stage trial finds that patients who are overweight or obese lose weight 19% of its body weight After 46 weeks of drug treatment.

In February, the companies also released positive mid-stage trial data for survodutide in patients with severe liver disease.

Boehringer Ingelheim hopes survodutide will emission According to a Reuters interview, it could be available as a treatment for obesity or liver disease in 2027 or 2028, as long as trial data are favorable.

AstraZeneca and Pfizer pills

AstraZeneca is also developing a daily weight loss drug called ECC5004. partnership it Signed an agreement with Chinese biotech company Eccogene in November.

AstraZeneca executives said the drug is quickly absorbed And it doesn’t stay in the stomach for too long, which can reduce side effects relative to existing treatments. Executives also said patients can take the drug alone or in combination with other oral medications, such as the diabetes drug Farxiga, to treat obesity and related health problems.

But such GLP-1-targeting drugs are still years away from reaching the market. Executives said on an earnings call in April that the company had completed a Phase 1 trial in patients with diabetes and planned to present the data at a medical conference later this year.

AstraZeneca’s experimental obesity drug AZD6234, also in early trials, targets another gut hormone called amylin.company Hope it can be combined AstraZeneca Chief Executive Pascal Soriot said in November that AZD6234 and its oral GLP-1 could 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 weight-loss drug by the middle of the year, which could determine the company’s fate in the weight-loss drug market. In December, the company scrapped the drug, danuglipron, after patients in a trial struggled to tolerate a twice-daily version of the drug.

Pfizer may have another opportunity to enter the market if it acquires a smaller obesity drugmaker. But for now, a deal seems unlikely as the company struggles to recover from a slump in business caused by the coronavirus pandemic last year.

“As this relates to bolt-on acquisitions, you wouldn’t expect us to do much on that front in the short term,” Pfizer Chief Financial Officer David Denton said on an earnings call last week.

Smaller biotech companies show promise

In addition to these major pharmaceutical companies, Viking Therapeutics, Altimmune, and Structure Therapeutics’ respective pipelines of weight-loss drugs are also attracting significant attention. All three companies have far fewer resources and manufacturing capabilities than Amgen or Pfizer, but that could change if they were acquired by a major drugmaker.

Viking Therapeutics March release Initial data from a mid-stage trial of its experimental injection targeting GLP-1 and GIP. Patients who received the once-weekly treatment lost 13.1% more weight than those who received a placebo after 13 weeks.

Viking CEO Brian Lian said on an investor call in March that Viking may conduct another Phase 2 trial that could last six to nine months. Jefferies analyst Akash Tewari wrote in a note the same month that Viking’s treatment may not be available until 2029 or later.

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

Structure Therapeutics is also developing an oral GLP-1 for the treatment of obesity and diabetes. But in a mid-stage trial in December, it fell short of Wall Street expectations for weight loss.

Drug helps obese patients lose weight about 5% After eight weeks, they lost weight compared to those who took a placebo.

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

Altimmune is developing a once-weekly obesity injection called pemvidutide that targets GLP-1 and glucagon.

In November, Altimmune released interim trial data showing its drug reduced body weight by an average of 15.6% after 48 weeks. The company also released more data from the study in March, showing its injection minimized the loss of muscle mass, a negative side effect of existing weight-loss injections.

Altimmune will meet with the U.S. Food and Drug Administration later this year to chart the direction of the shot.

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