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As Covid profits evaporate, Pfizer wants a piece of the burgeoning weight loss drug market.
Analysts say that soon data on Pfizer’s experimental obesity pill danuglipron will be crucial in determining how competitive the company can be against the dominant players in the field Eli Lilly and Novo Nordisk.
These companies have helped fuel the weight-loss drug industry’s fever pitch over the past year with weekly obesity and diabetes injections like Novo Nordisk’s Wegovy and Ozempic and Eli Lilly’s Mounjaro. Now they are racing to develop their own pills for obesity and diabetes.
Investors await Pfizer’s release second phase trial data on her twice-daily pill, in obese patients without diabetes, by the end of the year. They want to see the drug produce a similar level of weight loss as a once-a-day pill from Eli Lilly. Investors are also eager for Pfizer to release trial data early next year for a daily version of danuglipron, which is considered the most competitive form of the drug.
Pfizer sees a significant opportunity in the sector as it looks to recover from a sharp drop in demand for its Covid products and reverse a share price decline 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 a gut hormone to suppress a person’s appetite — could eventually grow to 90 billion dollarsand the company wants to capture 10 billion dollars of this part by oral treatment.
Investors have grown more pessimistic about Pfizer’s potential in the weight-loss drug industry since the company withdrew 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 is less excited about because it would be less convenient than a once-daily treatment.
Encouraging results from the trials may spark 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, then I think people might be able to look past this whole Covid salience,” Cantor Fitzgerald analyst Louise Chen told CNBC.
A weight loss pill could be a boon for all three companies. Oral medications are usually easier to prepare than injections and are more convenient for doctors to prescribe and patients to take. Pills could also potentially help relieve it supply restrictions are plaguing many of their injectable counterparts as demand for the drugs soars.
Before the data from the second phase of the trials, several analysts said that Pfizer’s twice-daily pill would have to be about as effective as Eli Lilly’s once-daily 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 needs to show weight loss at “mid-adolescent” rates to be considered competitive with Eli Lilly. pill, which is called orforgliprone.
Obese or overweight patients taking 45 milligrams of Eli Lilly’s pill once a day lost up to 14.7% of their body weightor 34 pounds, after 36 weeks, according to the results of the company’s phase two trials.
These results appear to be 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 came in a shorter trial period.
Overweight or obese patients who took 50 milligrams of Novo Nordisk’s drug once a day experienced an average weight loss of 15.1 percent after 68 weeks, according to phase three clinical trial results published in June.
Notably, Novo Nordisk already has 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 trial will provide a taste of the effects of twice-daily danuglipron over a longer period of time than the company’s previous studies of the drug. The study looked at the weight loss effect of the treatment on more than 600 adults with obesity after 26 or 32 weeks at different dosage amounts.
In an earlier interim trial, patients with type 2 diabetes who received a 120-milligram version of danuglipron twice daily lost about 10 kg on average after 16 weeks.
Another interim trial found that diabetic patients taking a 200-milligram version of danuglipron twice daily lost almost 12 kgor 5.8% of their weight, on average after 12 weeks.
Investors still want to see a release once a day
Even if Pfizer’s upcoming data is encouraging, many investors will still be eager to see the efficacy and safety profile of a daily release next year.
Doctors generally prefer once-daily pills to twice-daily drugs, Wells Fargo analyst Mohit Bansal said in a research note in June.
Health experts also previously told CNBC that patients often forget to take a drug if you need to do it twice, experts said.
A once-daily dose of danuglipron could also quell concerns about the potentially higher level of gastrointestinal side effects — such as nausea and vomiting — associated with the twice-daily version.
Leerink Partners’ Risinger wrote in an October note that the proportion of patients stopping Pfizer’s twice-daily danuglipron in the phase two trial will likely be higher than those who stopped taking Eli Lilly’s orforglipron. He said this is partly because the total daily dose of danuglipron is much higher, which may cause more adverse effects.
Analysts said Pfizer appeared to believe that a once-a-day version of the drug could reduce gastrointestinal side effects.
They pointed to Pfizer’s second-quarter earnings call, when the company’s chief scientific officer, Mikael Dolsten, suggested a daily can be improved a patient’s tolerability of the drug, which could reduce danuglipron’s “considered limiting” gastrointestinal side effects.
The bigger question is whether a 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 believes it is possible. During the company’s third-quarter earnings call, Dolsten said a critical late-stage test for the once-a-day version is “within our reach” next year.