Pfizer enters the weight loss drug market with Novo Nordisk, Eli Lilly

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As the Covid win evaporates, Pfizer wants a piece of the weight loss drug market.

Analysts say upcoming data on Pfizer’s experimental obesity pill, danuglipron, will be crucial in determining how competitive the company can be against the major players in the space. Eli Lilly and New Nordisk.

These companies helped the weight loss drug industry go gold over the past year with their weekly obesity and diabetes injections, such as Novo Nordisk’s Wegovy and Ozempic and Eli Lilly’s Mounjaro. They are now racing to develop their own pills for obesity and diabetes.

Investors are waiting for Pfizer to release phase two trial data on the pill twice a day, in obese patients without diabetes, before the end of the year. They want the drug to see the same level of weight loss as Eli Lilly’s one-a-day pill. Investors are also eager for Pfizer to release trial data early next year on a once-a-day version of danuglipron, which is seen as the more competitive form of the drug.

Pfizer sees huge opportunity in the sector, as it looks to recover from falling demand for its Covid products and reverse a fall in share price of around 40% this year.

CEO Albert Bourla said in January that the market for GLP-1s — a class of obesity and diabetes drugs that mimic gut hormones to suppress appetite — could eventually grow to $90 billion, and the company wants to capture $10 billion of that segment. with oral treatment.

Investors have become increasingly pessimistic about Pfizer’s ability in the weight loss drug business since the company scrapped its experimental one-day pill in June, citing elevated liver enzymes in people who took it. That left Pfizer with the twice-daily danuglipron, which is less exciting on Wall Street because it wouldn’t be as convenient as a once-daily treatment.

Encouraging results from the trials may fuel the same enthusiasm for Pfizer that has boosted the share prices of Novo Nordisk and Eli Lilly this year.

“If the Pfizer data is positive, I think people will probably be able to look beyond the rest of this Covid,” Cantor Fitzgerald analyst Louise Chen told CNBC.

A weight loss pill could be a win for all three companies. Oral drugs are usually easier to make than injections, and more convenient for doctors to prescribe and patients to take. Pills could also help to reduce the supply constraints that worry many of the injection peers as the demand for the drugs increases.

Eli Lilly’s pill sets the bar for efficacy

Ahead of the phase two trial data, several analysts have said that Pfizer’s twice-daily pill needs to be as effective as Eli Lilly’s once-a-day pill to be competitive. That means at least a 14% to 15% weight loss, Chen told CNBC.

Leerink Securities analyst David Risinger 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.

Overweight or obese patients who took 45 milligrams of Eli Lilly’s pill once a day lost up to 14.7% of their body weight, or 34 pounds, after 36 weeks, according to the company’s phase two trial results.

These results appear to be consistent with the weight reduction caused by a high-dose oral version of Novo Nordisk’s semaglutide – the active ingredient used in Ozempic and Wegovy – but they came over 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 the results of a phase three clinical trial published in June.

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

Pfizer’s upcoming phase two trial data 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 adults with obesity after 26 or 32 weeks at different dose levels.

In an earlier mid-life trial, patients with Type 2 diabetes who took a 120-milligram version of danuglipron twice a day lost about 10 pounds on average after 16 weeks.

Another moderate trial found that diabetic patients who took a 200-milligram version of danuglipron twice a day lost nearly 12 pounds, or 5.8% of their weight, on average after 12 weeks.

Investors still want to see a one-day version

Even though Pfizer’s upcoming data is encouraging, many investors will still want to see the same-day version’s efficacy and safety profile next year.

Physicians generally prefer once-daily pills over twice-daily drugs, Wells Fargo analyst Mohit Bansal said in a June research note.

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

A once-daily dose of danuglipron may also eliminate concerns about a potentially higher rate 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 note that the proportion of patients stopping treatment with Pfizer’s twice-daily danuglipron in a phase two trial will be higher than those who stopped taking Eli’s orforglipron Lilly. He said that’s partly because the total daily dose of danuglipron is much higher, which could cause more side effects.

Analysts said Pfizer likely believes a once-a-day version of the drug could reduce gastrointestinal side effects.

They pointed to Pfizer’s earnings call in the second quarter, when the company’s chief scientific officer, Mikael Dolsten, suggested that a one-day version could improve patient tolerance of the drug, which could reduce the gastrointestinal side effects “that have been observed as a restriction.” danuglipron.

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

Pfizer thinks it’s possible. During the company’s third-quarter earnings call, Dolsten said that critical late-stage testing for the one-day version is “within our reach” next year.

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