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Pfizer wants to enter the weight-loss drug market – and upcoming data will be crucial to its success

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As his Covid gains evaporate, Pfizer wants a share of the burgeoning weight-loss drug market.

Analysts say upcoming data on Pfizer’s experimental obesity pill, danuglipron, will be crucial in determining how competitive the company is compared to dominant players in the industry. Elie Lilly And Novo Nordisk.

These companies helped spark the weight-loss drug industry’s gold rush over the past year with their weekly obesity and diabetes shots, like Novo Nordisk’s Wegovy and Ozempic and Eli’s Mounjaro Lily. They are now racing to develop their own pills for obesity and diabetes.

Investors are expecting Pfizer to release data from the phase two trial of its twice-daily pill in obese non-diabetic patients by the end of the year. They want the drug to cause weight loss similar to that of a daily pill from Eli Lilly. Investors are also eagerly awaiting Pfizer to release data early next year from a trial of a once-daily version of danuglipron, considered the most competitive form of the drug.

Pfizer sees a major opportunity in this segment as it looks to rebound from plummeting demand for its Covid products and reverse a roughly 40% drop in stock price this year.

CEO Albert Bourla said in January that the market for GLP-1 – a class of obesity and diabetes drugs that mimic a gut hormone to suppress a person’s appetite – could ultimately reach $90 billion , and the company wants to capture $10 billion from this segment. with oral treatment.

Investors have become more pessimistic about Pfizer’s potential in the weight-loss drug industry since the company discontinued its experimental once-daily pill in June, citing elevated liver enzymes in people who took it. That left Pfizer with twice-daily danuglipron, which Wall Street was less excited about because it would be less practical than once-daily treatment.

The encouraging trial results could spark the same enthusiasm for Pfizer that has driven up the share prices of Novo Nordisk and Eli Lilly this year.

“If the Pfizer data is positive, then I think people might be able to look past this whole Covid overhang,” Louise Chen, an analyst at Cantor Fitzgerald, told CNBC.

A diet pill could be a boon for all three companies. Oral medications are generally easier to make than injections and more convenient for doctors and patients to prescribe. The pills could also potentially help ease the supply constraints facing many of their injectable counterparts as demand for the drugs skyrockets.

Eli Lilly’s pill sets the bar for effectiveness

Before the phase two trial data, several analysts said Pfizer’s twice-daily pill needed to be about as effective as Eli Lilly’s once-daily pill to be competitive. That means a weight loss of at least 14 to 15 percent, Chen told CNBC.

David Risinger, an analyst at Leerink Securities, wrote in October that Pfizer’s danuglipron must show weight reduction in the “mid-teens” percentages to be considered competitive with Eli Lilly’s. pill, called orforglipron.

Obese or overweight patients who took 45 milligrams of Eli Lilly’s pill once daily lost up to 14.7 percent of their body weight, or 34 pounds, after 36 weeks, according to trial results. phase two of the company.

These results appear consistent with weight loss caused by a high-dose oral version of Novo Nordisk’s semaglutide – the active ingredient used in Ozempic and Wegovy – but were obtained over a shorter trial period.

Overweight or obese patients who took 50 milligrams of Novo Nordisk’s drug once daily saw an average weight loss of 15.1% after 68 weeks, according to phase three clinical trial results released in June.

Notably, Novo Nordisk already markets a low-dose oral version of semaglutide under the name Rybelsus for the treatment of type 2 diabetes.

Data from Pfizer’s upcoming phase two trials will provide insight into the effects of twice-daily danuglipron over a longer period of time than the company’s previous studies of the drug. The study examined the weight loss effect of the treatment in more than 600 obese adults after 26 or 32 weeks at different doses.

In a previous interim trial, patients with type 2 diabetes who took a 120-milligram version of danuglipron twice daily lost about 10 pounds on average after 16 weeks.

Another interim trial found that diabetes patients who took a 200-milligram version of danuglipron twice daily lost nearly 12 pounds, or 5.8 percent of their weight, on average after 12 weeks.

Investors still want to see a daily version

Even though Pfizer’s upcoming data is encouraging, many investors will still be eager to learn the efficacy and safety profile of a once-daily version next year.

Doctors generally prefer once-daily pills to twice-daily medications, Wells Fargo analyst Mohit Bansal said in a research note in June.

Health experts also told CNBC that patients often forget to take a medication if they have to do it twice, the experts said.

A once-daily dose of danuglipron could also ease concerns about the potentially higher level of gastrointestinal side effects – such as nausea and vomiting – associated with the twice-daily version.

More CNBC health coverage

Leerink Partners’ Risinger wrote in an October memo that the proportion of patients who stop treatment with Pfizer’s twice-daily danuglipron in the phase two trial will likely be higher than those who stopped taking Eli Lilly’s orforglipron. He says this is partly because the total daily dose of danuglipron is much higher, which can lead to more side effects.

Analysts said Pfizer appears to believe a once-daily version of the drug could reduce gastrointestinal side effects.

They pointed to Pfizer’s second-quarter earnings announcement, when the company’s chief scientific officer, Mikael Dolsten, suggested that a once-daily version could improve patient tolerance of the drug, which could alleviate gastrointestinal side effects “which were considered limiting.” “Danuglipron.

The biggest question is whether a once-daily version of the pill will be ready for a phase three trial in 2024, which is seen as the next big step toward possible Food and Drug Administration approval.

Pfizer thinks it’s possible. During the company’s third-quarter earnings conference call, Dolsten said a crucial late-stage trial for the once-daily version was “within our reach” next year.

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