HEALTHCARE & MEDICARE

Pfizer's $4.9B Metsera acquisition makes it a major player in obesity drugs and more people

Pfizer's internal obesity drug development stumbled upon, but the drug giant passed a billion-dollar acquisition of the multi-billion-dollar clinical-stage company Metsera, whose pipeline of next-generation metabolic drugs could offer multiple differentiation in a crowded market of crowded weight loss treatments.

The terms of the acquisition agreement announced Monday that it called on Pfizer to pay $47.50 in cash per share for Metsera, evaluating biotech at about $4.9 billion. If the New York-based Metsera drug reaches clinical and regulatory milestones, Pfizer can pay up to $22.50 per share.

Pfizer chief strategy and innovation officer Andrew Baum spoke on a conference call Monday that many successful obesity products are on the market, but he said there is still huge unmet medical needs. He added that the association of obesity with other diseases means that Metsera's pipeline offers the potential to expand to other indications.

“We evaluated multiple external opportunities in the obesity space and thoroughly evaluated the best opportunities we identified in analysis and diligence, thus providing compelling potential differences in key asset attributes,” Baum said.

The state-of-the-art METSERA drug, Met-097i, is a peptide designed to activate the GLP-1 receptor, used with the weekly injection of Wegovy, from Novo Nordisk, Novo Nordisk and Zepbough from Eli Lilly. Although MET-097i is being evaluated as a phase 2 study of weekly injections, the drug’s design know-how gives the molecule a longer half-life to support longer dosing intervals. A separate interim study is being tested for monthly dosing.

In addition to reducing the delivery burden for patients, monthly delivery offers cost and supply chain advantages over weekly injectable products by reducing the number of injector equipment required. According to a speech by Pfizer investors, preliminary results for weekly and monthly doses are expected in 2026. Metsera's goal is to reduce drug administration. Currently, injectable GLP-1 candidates with every three-month dosing potential are currently under preclinical development.

Pharmaceutical companies are also trying to expand metabolic drugs to new targets, such as amylase receptors. Novo Nordisk has two plans for amyloid in the clinic. The goal also attracted the interest of Abbvie and Roche, each of which reached a deal this year to add plans to target Amylin in its pipeline. Metsera's Amylin competitor Met-233i is currently in its first phase of clinical development. Metsera executives say the drug has top-notch potential. The Phase 1 data were presented at the annual meeting of the European Diabetes Research Association last week. A separate phase 1 test is being conducted to evaluate the combination of MET-233i and Met097i.

The Metsera pipeline also includes pills, which is important because obesity drug research pursues more convenient dose selection, which can be an alternative to injections for initial treatment, or maintenance therapy after patients achieve their targets with injectable medications. Metsera has candidates for oral GLP-1 and amylose drugs in preclinical development.

Pfizer has previously determined that oral medications are a way to distinguish and compete with injectable obesity drugs. But in 2023, the company stopped the development of the oral GLP-1 drug Lotiglipron after a safety signal appeared in the Phase 1 test. The company then shifted its focus to a different oral GLP-1 drug, Danuglipron. The drug achieved statistically significant weight loss in the interim test, but these results also indicate that many patients strive to stick to their dosing twice a day. The development of Pfizer's once-daily oral Danuglipron in May showed signs of potential drug-induced liver damage during the Phase 1 test.

The Leerink Partners project notes that Metsera's drugs can reach a peak sales of $5 billion. In a September 9 study, analyst David Risinger wrote that data from the monthly injection of METSERA program MET-097I have shown that the effectiveness is equivalent to Zepbough for weekly injection of Lilly and may be better tolerated. Furthermore, the development of injections for initial titration this week should produce tolerability advantages over competitors and provide maximum flexibility for patients who want weekly or restart the therapy.

Metsera's Amylin candidate also offers the potential for monthly medication administration, Risinger said. He added that the company's oral GLP-1 drug can provide better efficacy and tolerance than Lilly's oral GLP-1 agonist Orforglipron, which is filing for the FDA.

The Metsera combination MET-233i and Met097i have another potential competitive advantage, which the company believes will be evaluated as a biopharmaceutical. Metsera administrators noted that compared with Novo's Semaglutide (Wegovy) and Lilly's Tirzepatide (Lilly's Tirzepatide (Zepbbound), the New Drug Application (NDA) pathway will be eligible for review of peptide sequences of more than 40 amino acids under the Biologics Application (BLA), compared with the New Drug Application (NDA) pathway. Classification as Biology will also provide protection against the Metsera drug combination for the compounds. The Food Drug and Cosmetics Act makes the biologics ineligible.

“We think this is an attractive difference from Tirzepatide and semaglutide, which has gone through an NDA review process, especially given the favorable positioning [Inflation Reduction Act] Risinger wrote. “Met-097i can also protect the negotiations of BLA (13 years, 9 years, respectively). Met-097i can also be protected from compounding, as the FDA notes that “biological products do not qualify for compound drug exemptions under Sections 503A and 503B of Sections FD&C.”

Pfizer agreed to pay $47.40 per share, representing a 42.5% premium to Friday's Messera's closing price. Metsera's IPO priced at $18 per share early this year. Metsera shareholders may gain more connections to achieving clinical and regulatory milestones. Contingently valuable rights in the transaction will be paid an additional $5 per share after the Met-097i and Met-233i combination begins. $7 per share will be paid after the FDA approves monthly MET-097I as a monotherapy; $10.50 per share is associated with FDA approval of the Met-097i and Met-233i combination.

Both companies' boards approved the acquisition, which still requires approval from Metsera shareholders as well as from regulators. The deal is expected to be completed in the fourth quarter of this year.

Photo: Dominick Reuter/AFP, via Getty Images

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