Pfizer Inc. announced plans to proceed with a once-daily version of its weight-loss pill, danuglipron, following positive data from early-stage trials. This move comes after the pharmaceutical giant discontinued a twice-daily formulation due to high dropout rates and significant side effects, including nausea and vomiting.
The revamped drug is part of the next generation of weight-loss medications, aiming to provide a more convenient alternative to the current injection-based treatments. Pfizer's initiative positions it alongside competitors such as Eli Lilly and Novo Nordisk, whose drugs Wegovy and Zepbound currently dominate the market.
In a joint statement, Pfizer and Germany's BioNTech disclosed that the once-daily version of danuglipron demonstrated a favorable safety profile with no observed liver enzyme elevations in over 1,400 healthy adult volunteers. This development is crucial for Pfizer, especially after the company faced setbacks with another weight-loss drug, lotiglipron, which was abandoned due to safety concerns.
The pharmaceutical industry sees immense potential in the weight-loss drug market, with some analysts projecting it to exceed $150 billion in annual sales by the early 2030s. Pfizer aims to capture a significant share of this market with its new formulation of danuglipron, which CEO Albert Bourla emphasized as part of the company's strategic focus on obesity treatments.
"Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates," stated Mikael Dolsten, Pfizer's outgoing Chief Scientific Officer. Dolsten has been pivotal in driving Pfizer's innovations, including the development of its COVID-19 vaccine. His departure marks a significant transition period for Pfizer as it seeks to strengthen its pipeline and market position.
The market's response to Pfizer's announcement was mixed. While Pfizer's shares rose by 2.8% to $29.14 in premarket trading, there remains skepticism among investors and analysts. JP Morgan analyst Chris Schott expressed concerns about the drug's side-effect profile, noting that Eli Lilly's experimental weight-loss pill has a significant head start. "We see a limited role for the asset absent more clarity on the tolerability profile of the new formulation," Schott commented.
Despite these challenges, Pfizer is moving ahead with its plans. The company intends to conduct further early-stage trials in the latter half of this year to determine the optimal dosage, with results expected by the first quarter of the following year. These trials will be critical in shaping the path towards regulatory approval.
Pfizer's focus on developing an oral GLP-1 agonist highlights the industry's shift towards more patient-friendly treatments. GLP-1s, initially developed for type 2 diabetes, mimic the hormone GLP-1 to regulate blood sugar, slow digestion, and suppress appetite. The convenience of a pill over an injection could significantly expand the market for weight-loss treatments.
The landscape for weight-loss drugs is highly competitive, with companies like Amgen and Viking Therapeutics also developing next-generation products. Pfizer's strategic partnerships and potential acquisitions could play a crucial role in its bid to lead the market. Bourla has indicated that while Pfizer is unlikely to acquire late-stage obesity treatments, the company is exploring licensing deals and early-stage drug collaborations.
Sales of Pfizer's COVID-19 vaccine and treatment have plummeted from their pandemic peaks, placing pressure on the company to find new growth drivers. The advancement of danuglipron and other experimental obesity drugs is part of Pfizer's broader strategy to diversify its portfolio and mitigate the impact of declining COVID-related revenues.
