Clesrovimab

Merck & Co.'s impending patent 'hill' from blockbuster cancer drug Keytruda (pembrolizumab) is increasingly looking summitable. Given its efforts to offset the PD-1 inhibitor's loss of exclusivity (LOE) in 2028, the pharma now sees $70 billion in commercial opportunity by mid-2030, CEO Rob Davis said at the JP Morgan Healthcare conference on Monday (see – Vital Signs: Merck & Co.'s cliff jumping raises stakes for biotech buyers)."That will be more than double what Keytruda will be at its peak sales based on consensus estimates in 2028," he said. "Importantly, that $70 billion is $20 billion more than where we were this time last year, due to what we've added through business development and our increasing confidence in some of our internal assets."10 key assetsThe company highlighted the breadth of its pipeline, including 20 growth drivers and 80 Phase III studies under way, though the majority of its $70-billion target — about 70% — is expected to come from 10 key assets with blockbuster potential. The suite includes commercial assets Winrevair (sotatercept-csrk), Ohtuvayre (ensifentrine) — gained from its $10-billion buyout of Verona Pharma in July — and Enflonsia (clesrovimab-cfor). Other programmes are enlicitide decanoate, ifinatamab deruxtecan, sacituzumab tirumotecan (sac-TMT), tulisokibart, MK-1405, MK-3000, and a weekly HIV regimen incorporating islatravir.Nearly all of the programmes are first-in-class molecules, and enlicitide and sac-TMT have received a Commissioner's National Priority Voucher. By the end of 2026, Davis expects to have clinically de-risked $35 billion of the $70 billion goal thanks to upcoming Phase III readouts, with a "big portion" materially de-risked in the next two years. Given the updated growth outlook, Davis said he was "quite confident that we will be in a position, at a minimum, to go through a very shallow period post-LOE, returning in a few years to growth. But we aspire for more. We aspire to grow through it," though he acknowledged that Merck is "not there yet."External opportunitiesSo how can Merck achieve growth while climbing its Keytruda patent hill? M&A could certainly be a key source. Davis noted that of its $70-billion goal, half of the revenues are expected to come from external opportunities, with internal projects responsible for the other half. "We've now invested over $60 billion since 2021 in business development," he said. "But importantly, we're not done. We have more to do."Merck will continue to focus on three disease areas — oncology, cardiometabolic and cardiopulmonary — and is open to clinical assets from Phase I through Phase III. Davis noted that as the LOE approaches, the pharma has been more focused on later-stage assets. And while its takeout sweet spot is in the $15-billion range, Davis said the company "has been very clear we're willing to go larger than that" — an important disclaimer as Merck is reportedly circling a potentially $20-billion takeout of cancer drug developer Revolution Medicines, though a highly anticipated JPM deal has not yet come to fruition (see – Vital Signs: The biggest buyers ahead of JPM)."If we see an opportunity that brings the science, where we see value will move, we have the capacity, I think, to do pretty much anything we would want to do," Davis concluded.

Speaking on the first day of this year's JP Morgan Healthcare Conference, Sanofi CEO Paul Hudson highlighted the significant role Beyfortus (nirsevimab) can play in preventing respiratory syncytial virus (RSV) in newborn infants, and described the current US administration as having "a particular sensitivity around vaccination.""Preferring to give the parents the choice is a very delicate line to walk because not everybody is well informed," Hudson said of paediatric vaccination. "When you're trying to protect communities, it leaves too much open to variability." Earlier this month, the Department of Health and Human Services (HHS) said it will pare back the number of vaccines recommended for children to align its childhood vaccination schedule more closely with Denmark's (see – ViewPoints: 'It's only going to get worse' — Offit's 2026 vaccine outlook).Despite considerable evidence supporting the efficacy and safety of Beyfortus and Merck & Co.'s newer Enflonsia (clesrovimab-cfor), HHS has promised to "rigorously" review the data on both long-acting mAbs, which are designed to protect young children during their first RSV season."We think the half-life [of Beyfortus] guarantees it can project the baby for the entire RSV season," said Hudson, suggesting that Merck has yet to demonstrate Enflonsia can offer the same durability of effect.Pushed on the impact of US vaccine policy changes instigated by HHS secretary Robert F. Kennedy Jr., Hudson was pragmatic."I'm asked all the time, 'What are you going to do to fix this?' And the truth is, we just need to stay extremely objective and keep presenting the evidence," he said. "There's really very little else we can do." Hudson suggested that the pending mid-term elections could bring pushback against recent policy changes and sounded hopeful that in the longer-term they would be reversed, noting that, "for most of our work, we plan for longer than three years."From a financial perspective, Beyfortus can offer unique benefits to healthcare systems. Priced like "a premium vaccine," despite being a mAb, it provides "payback in the same fiscal year, which has surprised everyone," Hudson told delegates in San Francisco."Access is within reach for almost every baby that needs protection, and there are 50,000-plus newborns with RSV who go into intensive care units in the US each year in very distressing circumstances, many with longer-term implications," Hudson noted, adding that the launch of Beyfortus reduced this number by between 80% and 90%.  "The real-world evidence that has been accumulated shows that it absolutely pays back within the current year and protects those babies, and that is just a gift to parents," Hudson posited. "But it's also a gift to healthcare systems."Analysis – Physician Views Preview: Will changes to US childhood vaccine recommendations move the needle in clinical practice?