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As its Covid gains evaporate, Pfizer wants a piece of the budding weight reduction drug market.
Analysts say upcoming data on Pfizer’s experimental obesity pill, danuglipron, shall be crucial in determining how competitive the corporate will be against the space’s dominant players Eli Lilly and Novo Nordisk.
Those corporations helped spark the burden loss drug industry gold rush during the last yr with their weekly obesity and diabetes injections, comparable to Novo Nordisk’s Wegovy and Ozempic and Eli Lilly’s Mounjaro. They are actually racing to develop their very own pills for obesity and diabetes.
Investors are waiting for Pfizer to release phase two trial data on its twice-daily pill, in obese patients without diabetes, by the tip of the yr. They wish to see the drug cause the same level of weight reduction as a once-daily pill from Eli Lilly. Investors are also anticipating Pfizer to release trial data early next yr on a once-daily version of danuglipron, which is seen because the more competitive type of the drug.
Pfizer sees a serious opportunity within the segment, because it looks to rebound from plummeting demand for its Covid products and reverse a roughly 40% share price drop this yr.
CEO Albert Bourla said in January that the marketplace for GLP-1s – a category of obesity and diabetes drugs that mimic a gut hormone to suppress an individual’s appetite – could eventually grow to $90 billion, and the corporate desires to capture $10 billion of that segment with an oral treatment.
Investors have grow to be more pessimistic about Pfizer’s potential in the burden loss drug industry because the company scrapped its experimental once-daily pill in June, citing elevated liver enzymes in individuals who took it. That left Pfizer with the twice-daily danuglipron, which Wall Street is less enthusiastic about because it will be less convenient than a once-a-day treatment.
Encouraging results from the trials may trigger the identical enthusiasm for Pfizer that has boosted the share prices of Novo Nordisk and Eli Lilly this yr.
“If Pfizer’s data is positive, then I feel people might have the option to look beyond all this Covid overhang,” Cantor Fitzgerald analyst Louise Chen told CNBC.
A weight reduction pill might be a boon for all three corporations. Oral drugs are typically easier to fabricate than injections, and more convenient for doctors to prescribe and patients to take. Pills could also potentially help alleviate the supply constraints plaguing lots of their injectable counterparts as demand for the drugs soars.
Eli Lilly’s pill sets the bar for efficacy
Ahead of the phase two trial data, several analysts have said Pfizer’s twice-daily pill needs to be about as effective as Eli Lilly’s once-a-day pill to be competitive. Meaning no less than a 14% to fifteen% weight reduction, Chen told CNBC.
Leerink Securities analyst David Risinger wrote in October that Pfizer’s danuglipron needs to indicate weight reduction within the “mid-teens” percentages to be considered competitive with Eli Lilly’s pill, which known as orforglipron.
Obese or chubby patients who took 45 milligrams of Eli Lilly’s pill once a day lost as much as 14.7% of their body weight, or 34 kilos, after 36 weeks, based on the corporate’s phase two trial results.
Those results appear consistent with the burden reduction attributable to a high-dose oral version of Novo Nordisk’s semaglutide – the energetic ingredient utilized in Ozempic and Wegovy – but got here over a shorter trial period.
Chubby or obese patients who took 50 milligrams of Novo Nordisk’s drug once a day saw a mean weight reduction of 15.1% after 68 weeks, based on 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.
Pfizer’s upcoming phase two trial data will provide a glimpse of twice-daily danuglipron’s effects over an extended time period than the corporate’s previous studies of the drug. The study examined the burden loss effect of the treatment in greater than 600 adults with obesity after 26 or 32 weeks at different dosage amounts.
In an earlier midstage trial, patients with Type 2 diabetes who took a 120-milligram version of danuglipron twice a day lost around 10 kilos on average after 16 weeks.
One other midstage trial found that diabetic patients who took a 200-milligram version of danuglipron twice a day lost nearly 12 kilos, or 5.8% of their weight, on average after 12 weeks.
Investors still wish to see a once-daily version
Even when Pfizer’s upcoming data is encouraging, many investors will still be desirous to see the efficacy and safety profile of a once-daily version next yr.
Physicians generally prefer once-daily pills over 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 medicine in the event that they have to do it twice, the experts said.
A once-daily danuglipron dose also could quell concerns in regards to the potentially higher level of gastrointestinal unintended effects – comparable to nausea and vomiting – related to the twice-daily version.
Leerink Partners’ Risinger wrote in an October note that the proportion of patients who discontinue treatment with Pfizer’s twice-daily danuglipron within the phase two trial will likely be higher than those that stopped taking Eli Lilly’s orforglipron. He said that is partly because danuglipron’s total day by day dose is much higher, which can cause more hostile effects.
Analysts said Pfizer appears to consider a once-daily version of the drug could lessen gastrointestinal unintended effects.
They pointed to Pfizer’s second-quarter earnings call, when the corporate’s chief scientific officer, Mikael Dolsten, suggested that a once-daily version may improve a patient’s tolerability of the drug, which could lessen the gastrointestinal unintended effects “which were seen as limiting” danuglipron.
The larger query is whether or not a once-daily version of the pill shall be ready for a phase three trial in 2024, which is seen as the following big step toward potential Food and Drug Administration approval.
Pfizer thinks it’s possible. In the course of the company’s third-quarter earnings call, Dolsten said a pivotal late-stage trial for the once-a-day version is “inside our reach” next yr.
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