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Drugmakers are trying to capitalize on the next big innovation coming to the weight loss blockbuster industry: effective, convenient, and potentially affordable obesity pills.
An estimated 40% of American adults are obese, making a successful pill a huge opportunity.
It is still too early to crown a winner, especially as key data from several pharmaceutical companies will be released later this year. And then there’s the all-important pricing issue for the big players.
But for now, an experimental oral drug by Eli Lilly seems to have an edge over pills Novo Nordisk And Pfizer – even though it may not get US approval first.
All three manufacturers are developing oral versions of GLP-1s, a class of drugs that mimic a hormone produced in the gut to suppress a person’s appetite. Novo Nordisk’s popular Wegovy and Ozempic treatments, which sparked a gold rush in the weight loss industry last year, are weekly injections of GLP-1, also known as semaglutide.
The pills are easier to manufacture than injections, which come in the form of single-use pens. That means the oral medications may be able to help relieve the symptoms delivery shortages infest their injectable counterparts.
Pills are also usually cheaper than injections, although it’s unclear if that will be the case with the obesity pills.
Wegovy’s list price over $1,300 per monthly package, and Ozempic’s is about $935. Novo Nordisk has a low-dose oral version of semaglutide that does the same list price as Ozempic for a monthly pack of 30 tablets. That pill, marketed as Rybelsusis only approved for type 2 diabetes.
None of the three drug companies have provided estimates of how much the new obesity pills would cost.
Novo Nordisk has one key advantage: The Danish company has already released phase three clinical trial results for its high-dose version of oral semaglutide, which is intended for weight management, and told CNBC it expects to seek approval from the Food and Drug Administration later this year. Drug Administration. year.
Eli Lilly is still in the middle of the third phase of clinical trials of his oral drug, orforglipron, which means it will likely hit the market later.
Still, analysts are confident in orforglipron’s long-term competitive advantage, especially after Eli Lilly revealed results of clinical trials in phase two last week which showed the strong efficacy profile of the drug.
Strong efficacy profile
According to Eli Lilly’s phase two results, overweight or obese patients who took 45 milligrams of orforglipron once a day lost weight up to 14.7% of their body weight after 36 weeks. That compares to a 2.3% weight loss for people who received a placebo.
Eli Lilly’s results seem consistent with the weight reduction caused by the Novo Nordisk pill, but were achieved after a shorter trial period.
Overweight or obese patients who took 50 milligrams of Novo Nordisk’s drug once a day saw an average weight loss of 15.1% after 68 weeks, according to clinical phase three results released Sunday.
Bank of America analyst Geoff Meacham said in a research note on Sunday that Eli Lilly’s available orforglipron data “compare quite favorably” to Novo Nordisk’s oral semaglutide, “except for caveats in the comparison of trials.”
Cantor Fitzgerald analyst Louise Chen told CNBC that orforglipron could potentially achieve even greater levels of weight loss over a longer trial period.
“The more you take these drugs, the more weight loss you’ll see until it hits plateaus, right?” Chen said. “So the thinking is that if you get pretty close to semaglutide’s weight loss in almost half the time with orforglipron, you’re likely to exceed it.”
Chen said the hope is that orforglipron leads to a reduction similar to that of Eli Lilly’s tirzepatide injection, which resulted in weight loss of about 22% at 72 weeks.
The third phase of the company’s clinical trials of orforglipron will study the drug over longer periods of time.
At least for now, analysts say Eli Lilly’s pill may also prevail over Pfizer’s oral GLP-1, danugliprone, which is still in phase two clinical trials.
Patients with type 2 diabetes who took a 120 milligram version of danugliprone twice daily lost about 10 pounds on average after 16 weeks, according to the results of a phase two clinical trial.
It is difficult to compare the efficacy of danugliprone to that of other oral GLP-1s due to the different patient populations and the lack of long-term data on the drug.
A Pfizer spokesperson told CNBC that the company is still studying the drug in further phase two clinical trials and would “also look at longer data” beyond 16 weeks into the future.
Easy to use
Wells Fargo analyst Mohit Bansal said in a research note that Pfizer’s danuglipron will be challenged to compete in the oral GLP-1 space given Eli Lilly’s strong orforglipron data.
He added that doctors generally prefer once-daily pills — such as orforglipron — to twice-daily drugs like danuglipron.
Health experts seem to agree: “Patient compliance increases tremendously when it’s a once-a-day pill, so it’s definitely a big benefit. People often miss a few times a week if they take something twice to take every day.” said Dr. John Yoona professor of endocrinology at UC Davis Health.
Pfizer is developing a once-daily version of danuglipron.
The company also said Monday it would stop developing another experimental pill, lotigliprone, which Bansal said was the “more attractive GLP-1” in Pfizer’s portfolio because it’s only taken once a day. Shares of Pfizer fell 5% on Monday following that news.
But Pfizer and Eli Lilly share one key advantage over Novo Nordisk’s oral semaglutide: no dietary restrictions.
Patients should take Novo Nordisk oral semaglutide on an empty stomach in the morning with no more than four ounces of plain water, according to the FDA label for the low-dose, approved version of the drug. They are instructed to wait 30 minutes before eating, drinking, or taking other oral medications.
That’s because Novo Nordisk’s oral semaglutide is a peptide drug, which the gut says is harder to absorb Dr. Eduardo Grunvaldmedical director of UC San Diego’s Center for Advanced Weight Management.
“If you take it with food or drink, it just doesn’t get absorbed efficiently,” Grunvald told CNBC.
He said Eli Lilly and Pfizer pills are non-peptide GLP-1s, which are more easily absorbed and don’t require dietary restrictions.
Cantor Fitzgerald’s Chen said market research suggests those limitations are a “major negative for patients,” making Eli Lilly and Pfizer’s pills convenient alternatives.
Overall, Eli Lilly’s orforglipron seems to be the top contender in the weight loss pill space due to its strong efficacy data and convenience as a once-daily pill with no dietary restrictions.
But Chen stressed that the data revealed later this year could potentially change that: “Save some space for the arrival of new data.”
For health experts like Grunvald, naming a winner in the field of oral weight-loss drugs is less important.
“I think these oral GLP-1s mean we have more tools in our toolbox, with more options for different people who may respond differently to different drugs,” he said. “That’s really the future of it all.”