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Amgen wants to enter the booming weight-loss drug market – and is taking a different approach

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

Mario Tama | Getty Images

Amgen is taking a new approach in trying to stand out among a crowded field of drugmakers racing to develop the next blockbuster weight-loss drug.

Biotech company is testing an injectable treatment that helps people lose weight differently than existing injections of Novo Nordisk And Elie Lilly, and other obesity drugs in development. Amgen’s treatment, called MariTide, also appears to help patients maintain their weight after they stop taking it.

The drugmaker is also testing its drug to be taken once a month or even less frequently, which could be more convenient than the weekly medications available on the market.

It’s too early to tell how competitive Amgen will be in the nascent weight-loss drug business, which Novo Nordisk and Eli Lilly have so far dominated.

Some analysts estimate the market could reach $100 billion by the end of the decade, which could leave room for new competitors. Goldman Sachs also predicts that between 10 and 70 million Americans will take weight-loss drugs by 2028.

The available data on Amgen’s injectable drug is promising, but it comes from a small, early-stage clinical trial. The Thousand Oaks, Calif.-based company is also developing an oral drug and other treatments. for obesity, but has disclosed few details about them.

Investors and health experts will likely have a better sense of Amgen’s prospects later this year: The drugmaker plans to release early data from an ongoing interim trial of MariTide, as well as data from the first phase of his pill against obesity.

It’s also unclear whether Amgen’s treatments will be cheaper than existing weight-loss drugs, which cost about $1,000 a month.

Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound lead a new class of obesity treatments that have sparked relentless patient demand — and investor interest — despite their high prices and insurance coverage limited.

Eli Lilly and Novo Nordisk have also struggled to offer sufficient supplies of their treatments, which could give other companies a chance to gain market share.

How Amgen’s treatment is different

Amgen’s drug offers a new approach to weight loss.

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

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

Amgen’s decision to reduce rather than boost GIP activity is based on genetic research suggesting that blocking the receptor is linked to decreased fat mass and body weight, company executives said .

Some Approved and Investigational Weight Loss Drugs

  • Wegovy from Novo Nordisk: Approved weekly injection that activates GLP-1
  • Zepbound by Eli Lilly: Approved weekly injection that activates GLP-1 and GIP
  • Saxenda from Novo Nordisk: Approved weekly injection that activates GLP-1
  • MariTide from Amgen: Experimental monthly injection that activates GLP-1 and blocks GIP
  • Danuglipron from Pfizer: Experimental once-daily pill that activates GLP-1
  • VK2735 from Viking Therapeutics: Experimental weekly injection that activates GLP-1 and GIP
  • Pemvidutide from Altimmune: Investigational weekly injection that activates GLP-1 and another gut hormone called glucagon
  • GSBR-1290 from Structure Therapeutics: Experimental weekly pill that activates GLP-1
  • Survodutide from Zealand Pharma, Boehringer Ingelheim: Experimental weekly injection that activates GLP-1 and glucagon

This seems to contradict how Zepbound works. Eli Lilly’s approach proved effective: the treatment helped obese patients lose up to 22.5% of their weight after 72 weeks in a late-stage trial.

But Amgen’s MartiTide was also found to be effective in a small preliminary study.

Patients given the highest dose of Amgen’s drug – 420 milligrams – lost an average of 14.5% of their body weight each month in just 12 weeks, according to phase one trial data released this month. latest in the journal Nature Metabolism.

There is a broader debate among researchers about why both approaches – blocking and activating GIP – are effective in promoting weight loss.

One theory is that repeated activation of the GIP receptor, as Zepbound does, ultimately causes the body to “self-regulate” and ensure that there is not too much GIP activity, said Dr. Dr Caroline Apovian, director of the Center for Weight. Management and Wellness at Brigham and Women’s Hospital.

This decreases GIP activity overall, which essentially appears to mimic what Amgen’s drug achieves when it blocks the GIP receptor. But Apovian cautioned that “none of this is proven” and more data is needed.

The drug could lead to more lasting weight loss

Amgen’s treatment may be more effective than its competitors in helping people maintain their weight loss, even if patients take it less frequently, early trial data suggests.

Amgen’s study included 110 patients who suffered from obesity but did not have diabetes. Patients in one group were randomly assigned to receive a single dose of the drug and were followed for 150 days, while a second group received a dose every four weeks for three months.

An obese patient receives an injection of weight loss medication.

Joe Buglewicz | The Washington Post | Getty Images

Patients who received a single injection of the highest dose of MariTide lost up to 8.2% of their body weight after 92 days. This suggests that a single injection of the drug has a prolonged weight loss effect, according to the study authors.

In the group that received multiple doses of the drug, patients appeared to maintain their maximum weight loss until about two months after their last dose. Their body weight started to slowly return after that. However, their weight was 11.2% lower five months after receiving the last dose.

“We believe that significant weight loss is already 5%. If you take the drug Amgen, lose 14.5%, stop the drug and still have a weight loss of 11.2% after a few months, that’s is significant,” said Dr. Holly Lofton, director of Weight Loss. Management program at NYU Langone Health and a physician specializing in obesity medicine. But she stressed the need to study the treatment in a broader group of people.

The sustained weight loss seen in Amgen’s study appears to contrast with results seen in clinical trials of Zepbound and Wegovy. Patients in these studies saw their weight rebound sooner after stopping the injections.

Once a month or even less frequent administration

The frequency of administration of Amgen’s drug also sets it apart. Those taking Wegovy or Zepbound must take weekly doses, versus MariTide once a month.

Amgen’s trial used monthly dosing in part because patients saw sustained weight loss whether they received a single injection or multiple injections of the company’s drug, according to the study authors.

Amgen’s treatment may also stay in the body much longer than current therapies like Wegovy and Zepbound because it includes a monoclonal antibody, the authors added.

An injector pen of Zepbound, Eli Lilly’s weight loss drug, is on display in New York, the United States, December 11, 2023.

Brendan McDermid | Reuters

Amgen’s MariTide “has the advantage of lasting much longer. Even if you give a high dose, your body will still be exposed to the drug for a month or two, making it clear that you’re not doing it.” I don’t need to take it every week,” Matt Phipps, an analyst at William Blair & Company, told CNBC.

Phipps said people generally don’t want to get injections often, so some patients might prefer a monthly injection like Amgen’s MariTide for a condition that will likely require chronic treatment.

But he noted that a patient’s choice may also depend on whether the level of weight loss and side effects of Amgen’s drug end up being comparable to those of existing weekly injections.

Amgen’s ongoing phase two trial aims to determine whether patients can take its drug even less frequently than once a month.

Phase two trial will provide more clarity

Amgen’s longer-term phase two study of nearly 600 patients will provide more clarity on MariTide’s competitiveness versus Wegovy and Zepbound. The company is studying which dose and schedule is best for patients. It plans to release initial trial results later this year.

Some analysts said the phase two trial could help answer several questions, including how well patients tolerate the treatment at different doses.

The 52-week study is testing 11 different patient groups at various dosage levels and treatment regimens. This involves starting some patients with a lower dose of a medication and gradually increasing it until they reach a higher target dose.

This dose increase could help reduce side effects experienced by some patients after taking their first dose of MariTide in the phase one trial, according to Phipps.

In this trial, the safety and side effects of Amgen’s drug were similar to those of other GLP-1 drugs. Nausea and vomiting were the most commonly reported side effects and usually lasted about 72 hours.

According to the study, four out of eight patients in a group receiving the highest dose of the treatment withdrew before receiving a second injection due to mild gastrointestinal problems. But no other patients stopped taking the drug due to adverse events in any of the different dosing groups, Amgen Chief Medical Officer Paul Burton said at a conference earlier this month .

“It’s a little early to conclude that the drug will not be tolerated by patients based on this first-phase data,” said Phipps of William Blair & Company.

Another part of Amgen’s phase two trial will also look at weight loss beyond 52 weeks, which will provide a clearer picture of how long the drug is effective.

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