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Addressing the performance of Pfizer’s vaccines business Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. Even without accounting for the COVID declines that have punctuated Pfizer’s earnings in recent years, the company’s vaccines business appeared to be on the back foot in the third quarter, brought low by a U.S. market that is currently proving unfavorable for immunizations.Among the shots that receive top billing in Pfizer’s earnings reports, only Pfizer’s tick-borne encephalitis shot TicoVac posted sales gains (PDF) for the three months that ended in September.Meanwhile, Pfizer’s Prevnar family of pneumococcal vaccines, its respiratory syncytial virus (RSV), shot Abrysvo, its COVID-19 prevention shot, Comirnaty, all suffered sales declines compared to the same period in 2024, according to a Nov. 4 earnings announcement.Notably, in the case of Prevnar and Abrysvo, ex-U.S. sales of the vaccines increased—and in Abrysvo’s case at a significant 75%—but revenues in the U.S. brought down their overall performance.Taking a closer look at the numbers, Comirnaty sales slipped 19% globally to $1.15 billion, the Prevnar franchise experienced a 3% global sales decline to $1.7 billion, and Abrysvo’s performance decreased 22% to sales of $279 million in Q3. Slipping COVID-19 vaccine sales are nothing new for Pfizer, which has struggled to meet tough COVID-era revenue comparisons ever since the market for its vaccine and coronavirus antiviral, Paxlovid, transitioned from pandemic to endemic. Nevertheless, the company grappled with a new constraint in the third quarter, noting in a press release that Comirnaty has struggled of late thanks to a “narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population.”Pfizer won an FDA nod for an updated version of its BioNTech-partnered COVID vaccine in late August. But unlike with past FDA endorsements, the new nod carries restrictions on the vaccine’s use in many age groups, to include only people with underlying health conditions.Addressing the performance of Pfizer’s vaccines business more broadly Tuesday, CEO Albert Bourla indicated an interest in opportunities outside the U.S. The company’s roster of immunizations is a “key area of focus in international markets,” the chief executive said on a call with analysts.Speaking to Abrysvo’s recent struggles in the U.S. specifically, Bourla admitted that Pfizer is “experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV.”“Still,” he continued, “we are continuing to strengthen our position with a 59% market share in the U.S.”And despite the sales slump in the U.S. this past quarter, Pfizer’s Prevnar dynasty still leads in pediatric pneumococcal vaccination worldwide and among conjugated pneumococcal vaccines for adults in the U.S., Bourla emphasized.Beyond Comirnaty, Pfizer’s COVID treatment Paxlovid endured a precipitous sales decline in the third quarter, falling a staggering 55% to $1.2 billion. The antiviral took a one-two punch in the period stemming from “reduced demand from lower levels of disease incidence,” as well as an unfavorable comparison to a government stockpiling order for the drug that Pfizer booked last year, the company’s chief financial officer, Dave Denton, said on the earnings call.Speaking to Pfizer’s overall performance in the quarter and through the rest of the year, Denton admitted that there is currently some “softness in our COVID products due to lower vaccination rates and COVID infection rates.”The low end of the drugmaker’s 2025 forecast “would assume that the COVID franchise continues a very modest uptake for the balance of this year, particular in the U.S.,” Denton said in response to an analyst question about Pfizer’s ability to meet its financial guidance, which sits in a range between $61 billion and $64 billion for the full year.“However, as you know, the COVID franchise is subject to peaks and valleys,” he added. “If there happens to be a wave of COVID in the next several months, you can see utilization spike up.”Removing COVID from the equation, Pfizer’s innovative drug franchises performed better overall in the third quarter. Without the negative effects from Comirnaty and Paxlovid, Pfizer’s portfolio of branded medicines grew sales 4% for the period.In particular, the drugmaker spotlighted the momentum behind Bristol Myers Squibb-partnered anticoagulant Eliquis, which grew 22% in Q3 to $2 billion; Nurtec ODT in migraine, which was up 22% to $412 million; and the company’s Vyndaqel family of drugs for amyloidosis, which increased revenues by 7% globally to nearly $1.6 billion.Vyndaqel is now facing fresh competition in the shape of Alnylam’s Amvuttra, which passed muster at the FDA in March. While Pfizer’s drug has continued to hold its own for the time being, analysts on the company’s call were curious to hear how the competitive dynamics in the transthyretin amyloid cardiomyopathy (ATTR-CM) market are evolving.“There’s obviously new competition in the category,” Aamir Malik, Pfizer’s chief U.S. commercial officer, admitted. That said, the Vyndaqel franchise “is still the only ATTR-CM product that has statistically significant reductions in both mortality and [cardiovascular]-related hospitalizations together and as a standalone,” the commercial chief stressed.“And it’s also the only product where there is a once-daily capsule, placebo-like safety and near complete [transthyretin] TTR stabilization, and we’ve got 90% access for Vyndamax across the U.S. now,” Malik added. Vyndamax is a single-capsule presentation of Pfizer’s drug that uses the same active ingredient as Vyndaqel.In Q3 specifically, Pfizer’s Vyndaqel franchise benefited from “very strong demand growth,” reinforced by the medicine’s “continued market share leadership,” Malik explained.Nevertheless, that volume growth was offset by a pair of “gross-to-net headwinds,” Malik pointed out, spotlighting IRA manufacturer rebates and “payer contracting” during the earnings period.“So Vyndamax is performing exactly where we thought it would, and consistent with what we guided,” Malik said. “And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics—and that’s going to continue to grow our volume.”Even though the Vyndaqel franchise is now facing some competition among treatment-naïve patients, “Amvuttra has driven minimal switching to date,” Malik added, calling out Alnylam’s ATTR-CM rival by name. Pfizer reported its earnings as it grapples with Novo Nordisk over the companies’ competing efforts to purchase obesity biotech Metsera. While Pfizer’s planned $4.9 billion purchase of the company appeared solidly in the books as of late September, Novo Nordisk swooped in last week with a $6.5 billion counterbid.Pfizer has launched legal efforts to scupper Novo’s offer and has also raised its initial bid for Metsera, which Novo countered again with its own higher proposal Tuesday morning. For now, leadership at Pfizer appears steadfast in their belief that Novo’s attempt to cut in on the deal will fail on legal grounds, accusing their Danish rival of violating U.S. antitrust laws to stymie an emerging obesity rival.“Novo Nordisk's offer is illusory and cannot constitute a superior proposal under the terms of our merger agreement with Metsera, because it violates antitrust law and there is a high risk it will never be consummated,” Bourla said of the situation Tuesday. 

A deal with Blackstone Life Sciences gives some idea of how big a bet Merck is making on sac-TMT. Merck & Co. began Tuesday with back-to-back deals, revealing separate agreements to pay $150 million upfront for full control of an early-phase asset and pocket $700 million to support an expansive pivotal oncology push.The influx of cash comes from Blackstone Life Sciences, which has agreed to fund a portion of the cost of developing sacituzumab tirumotecan (sac-TMT) throughout 2026. Merck recently started its 15th global phase 3 trial of the antibody-drug conjugate (ADC). That broad bet reflects a belief that the TROP2-directed ADC can become a “workhorse” for Merck as it prepares for the arrival of biosimilar Keytruda copies, Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical development, recently told Fierce Pharma.Teaming up with Blackstone allows Merck to share the burden of validating sac-TMT in a wide range of settings. In exchange, the drugmaker has agreed to pay Blackstone low- to mid-single-digit royalties on net sales of sac-TMT across all approved indications in its marketing territories, provided the ADC wins FDA approval in first-line triple-negative-breast cancer (TNBC) based on findings of the TroFuse-011 trial.Merck secured ex-China rights to sac-TMT from Kelun-Biotech for $47 million upfront and up to $1.4 billion in milestones in 2022. The agreement gave Merck a rival to Gilead Sciences' Trodelvy and AstraZeneca and Daiichi Sankyo’s Datroway, TROP2-directed ADCs that are approved in the U.S. The rivalry between Trodelvy and Datroway is set to expand to the first-line TNBC market referenced in Merck’s deal with Blackstone. The Blackstone deal gives some idea of how big a bet Merck is making on sac-TMT—and the opportunity that awaits the ADC if it lives up to the company’s expectations. Merck said the $700 million will only fund a portion of its sac-TMT development costs. At a 4% royalty rate, total sac-TMT sales would need to reach $17.5 billion before Blackstone’s returns exceeded its $700 million upfront outlay. Another deal unveiled Tuesday showed one way Blackstone could accelerate the timeline for making a return on its investment. Royalty Pharma has paid funds managed by Blackstone $310 million for royalty interest in Alnylam’s Amvuttra. Blackstone secured the interest in 2020 by committing up to $150 million to support a phase 3 trial of Amvuttra, much like it is now doing for Merck’s sac-TMT. Five minutes before disclosing the Blackstone agreement, Merck revealed that it has struck a deal with Dr. Falk Pharma for MK-8690. Merck acquired the anti-CD30 antibody in 2023 in its $10.8 billion takeover of Prometheus Biosciences, a deal that primarily focused on the anti-TL1A candidate PRA023. In 2020, Prometheus accepted a “low seven figures” upfront payment from Falk to form a co-development pact.The outlay, plus R&D funding and other commitments, secured Falk rights to the candidate in Europe, Australia and New Zealand. Merck has retaken control by offering Falk $150 million upfront to end the collaboration. Falk is eligible to receive a payment associated with a development milestone and royalties on sales in certain territories. Merck’s outlay represents a show of confidence in a candidate that has largely flown under the radar to date. Dean Li, M.D., Ph.D., president of Merck Research Laboratories, commented on the CD30 program at a Goldman Sachs event in June 2024, telling attendees to expect more details “in the next year or so.” The forecast was tied to a phase 2 program that, based on information on ClinicalTrials.gov, is yet to get underway.