Thursday, August 31, 2023

Big pharma’s blockbuster obesity drug battle is just getting started

  • Novo Nordisk and Eli Lilly are both over a century-old, but one of their biggest successes ever is just taking hold, the blockbuster obesity drugs Ozempic, Wegovy and Mounjaro, the latter of which just saw its quarterly sales grow year over year from $16 million to nearly $1 billion.
  • Pfizer, Amgen and other pharmaceutical companies are rushing to develop weight-loss drugs, though they may not be available for another year or more.
  • Barclays predicts a $100 billion global market for obesity drugs by around 2030.
  • And that’s without the latest headlines that these drugs are now also being investigated as treatments for dementia and addiction.

In their most recent earnings reports, Novo Nordisk and Eli Lilly proved why they are the undisputed heavyweights in the prizefight for control of the rapidly growing weight-loss medications market. Beyond staggering sales figures for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro, news of a study showing Wegovy can reduce the risk of heart disease and the anticipated approval of even more powerful prescription drugs to treat obesity will only strengthen the position of these venerable pharmaceutical giants, which have been in business for 100 years and 147 years, respectively.

Even so, their competitors are not ceding the market to the current leaders. Pfizer, Amgen and other pharmaceutical companies are rushing to develop weight-loss drugs, though they may not be available for another year or more.

Ozempic and Wegovy are both GLP-1 agonists, substances originally formulated by Novo to treat type 2 diabetes. Besides controlling blood sugar, GLP-1s affect hunger signals to the brain, tricking the body into feeling full and slowing the rate at which the stomach empties. The sales growth has been so sharp that Novo Nordisk contributed the majority of recent economic growth for its home nation of Denmark.

The Food and Drug Administration approved Ozempic in 2017 for diabetes and Wegovy in 2021 to treat obesity. Over time, both reduce body weight by about 15%. Mounjaro, introduced in 2022 to treat diabetes, contains GLP-1, plus GIP, a similar appetite suppressor that can lead to weight loss. All three drugs are prescribed as injectable pens that patients self-administer weekly.

On August 8, Lilly reported that its second-quarter income jumped 85% from the same period a year ago, driven in large part by Mounjaro, which generated $979.7 million in sales for the quarter, compared to $16 million in the year-ago period and $569 million in the first quarter of this year. In December, analysts at SVB Securities projected that Mounjaro sales could reach $26.4 billion by 2030.

A month earlier, Lilly released data from a phase three trial of the drug, showing that it helped patients with obesity, though not diabetes, lose up to 26.6% of their body weight after 84 weeks of treatment. Mounjaro is currently only approved by the Food and Drug Administration to treat diabetes, but the company has filed for FDA approval of Mounjaro specifically to treat obesity, which could come later this year or in early 2024.

Novo traded earnings jabs with its opponent on August 10, reporting that in the first six months of this year, sales of Wegovy soared 344% in the U.S. alone to nearly $1.7 billion, while sales of Ozempic jumped 50% to more than $3.7 billion. According to financial analyst firm FactSet, sales of Wegovy and Novo’s other weight-loss injectable, Saxenda, could reach $6.1 billion before the year is out and $15 billion annually by 2030. (Saxenda, on the market since 2015, reduces weight by 6%-8%.)

Potentially bigger news came a couple of days earlier, when Novo released headline results of SELECT, a multi-year clinical trial of Wegovy, showing that it reduced the risk of major cardiovascular events such as heart attacks or strokes by 20%, compared with a placebo. During the earnings call with analysts, Novo CEO Lars Fruergaard Jorgensen said that the SELECT trial “underlines the importance of recognizing obesity as a serious chronic disease.”

The company expects to file for regulatory approvals of a label indication expansion for Wegovy in the U.S. and the European Union this year, adding the drug’s cardiovascular benefits.

Attitudes about obesity being transformed
Overall, per the CDC, obesity in the U.S. affects 100 million (41.9%) adults and 14.7 million (19.7%) children and accounts for approximately $147 billion in annual health care costs. Historically, obesity has been considered a behavioral and lifestyle condition among people lacking the willpower to moderate eating habits and exercise regularly. But those attitudes have been changing, not only in society at large but also among health care providers.

In 2021, Novo announced plans to invest nearly $2.6 billion to build three new ingredients manufacturing facilities and to expand an existing production site in Kalundborg, Denmark.​ Then last May, the company committed $2.3 billion to expand its site in Hillerød, Denmark. In April, Lilly said it is investing an additional $1.6 billion in its two new factories in Boone County, Indiana, bringing the company’s total commitment to the site to $3.7 billion.

At an American Diabetes Association event in June, Lilly released phase two data for orforglipron, its first oral drug for obesity, saying it achieved up to 14.7% weight reduction after 36 weeks. The company also released phase two data from trials on retatrutide, an injectable obesity medication that achieved up to 17.5% weight reduction after 24 weeks.

Pfizer was testing two different oral drugs to treat type 2 diabetes and obesity, but is now focusing on one, danuglipron, after phase two trial results. “While we have our data from the type 2 diabetes study [of danuglipron], we are still studying the potential in obesity,” a Pfizer spokesperson said in an email. “When we have this information, which should be later this fall, we will make a plan for what the phase three [trial] will look like.”

In December, Amgen reported that in phase one tests of its injectable obesity drug, AMG133, patients showed a weight loss of 14.5% after 12 weeks of treatment. Phase two trials are ongoing, with data expected in 2024, and a product launch is not likely before 2026.

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