Nirsevimab

Shares of French pharmaceutical giant Sanofi ticked up Thursday morning with the release of an earnings report that beat Wall Street expectations.Sanofi recorded a little over 10.7 billion euros, or $9.9 billion, in net sales from April through June, a nearly 8% increase from the same three-month period a year prior. Earnings per share was 1.73 euros, which, though down less than 1% overall, reflected a 4% increase after factoring in currency exchange rates. According to the investment firm Leerink Partners, the sales and earnings per share figures were respectively 3% and 5% above the average analyst estimate.Much of that growth came from Dupixent, an anti-inflammatory agent used to treat a variety of conditions, including eczema and asthma. Dupixent sales rose almost 30% in the quarter, to 3.3 billion euros, and Sanofi said the drug is still on track to hit around 13 billion euros this year.Analysts were also impressed with how several other products performed. Sales of Lantus, a type of insulin and one of Sanofis legacy medicines, increased 13% to $398 million. Newer offerings like the hemophilia therapy Altuviiio, the blood cancer treatment Sarclisa and the Pompe disease drug Nexviazyme beat sales predictions as well.One of the worlds largest vaccine makers, Sanofi recorded an almost 7% dip in its portfolio of shots, which it pinned on the absence of COVID-19 sales.The company has a new, sought-after antibody drug for RSV, or respiratory syncytial virus, an infection of the lungs and airways that can be particularly dangerous for babies and the elderly. But meeting that demand has been more challenging than Sanofi and its commercial partner AstraZeneca anticipated, which has led to shortages. The companies are now trying to get two additional filling lines cleared by health authorities to expand supply for the Northern Hemisphere in time for the next RSV season.Sales of the shot, sold as Beyfortus, totaled 18 million euros in the second quarter, but theyre expected to grow substantially.In a note to clients, Jefferies Peter Welford predicted that Dupixent and Beyfortus will cause analysts to continue upping their sales estimates for Sanofi. He also argued the depth of Sanofis research directed at the immune system is underappreciated by investors.There, the company has more than half a dozen experimental medicines in mid- to late-stage testing. The list includes a drug named amlitelimab, which Sanofi acquired through the billion-dollar acquisition of a U.K.-based biotechnology company in 2021. Last summer, the drug hit the main goal of a study focused on moderate-to-severe eczema.That wasnt the only recent success. Shortly before announcing the amlitelimab findings, Sanofi reported that two of its other immune system therapies had scored positive results in trials evaluating them, respectively, against multiple sclerosis and COPD.Sanofi then expanded its pipeline further in October by paying $500 million to collaborate with Teva Pharmaceutical on a potential medicine for inflammatory bowel disease. Known as duvakitug, the medicine inhibits a protein that regulates inflammation and fibrosis. Drugs targeting this TL1A protein have attracted much attention over the past year, with Merck & Co. and Rocheeach spending billions of dollars to get their hands on one.On Thursday, Sanofi and Teva said they have sped up the development of duvakitug and now expect high-level results from a mid-stage program toward the end of this year. The program is testing the drug in patients with ulcerative colitis or Crohns disease.Sanofi shares were up 4% by late Thursday morning, to trade just above $53 apiece. '

Merck & Co. announced Tuesday that its investigational monoclonal antibody clesrovimab (MK-1654) met all primary safety and efficacy endpoints in a Phase IIb/III trial for the prevention of respiratory syncytial virus (RSV) in newborns, potentially setting the stage for a head-to-head battle with Sanofi and AstraZeneca's Beyfortus (nirsevimab)."As a widespread illness globally, RSV is the leading cause of hospitalisation for healthy infants," stated Paula Annunziato, senior vice president of infectious diseases and vaccines at Merck Research Laboratories. "We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families."The trial, known as MK-1654-004, evaluated clesrovimab in 3632 healthy preterm and full-term infants. Participants were randomly assigned either a single intramuscular dose of clesrovimab or placebo. The primary efficacy endpoint focused on the incidence of RSV-associated medically attended lower respiratory infections (MALRI) from day 1 to 150 post-dose, compared to placebo. Detailed study findings will be shared at an upcoming scientific meeting.Beyfortus gained European clearance in 2022 and FDA approval in July of last year to protect newborns and infants, born during or entering their first RSV season, against lower respiratory tract disease caused by the virus. The long-acting monoclonal antibody is also indicated in the US for children aged up to two years old who remain vulnerable to severe RSV disease through their second RSV season. Priced at $495 per dose, a panel of the US Centers for Disease Control and Prevention subsequently recommended that babies receive Beyfortus to protect them from illness.'Minimal' competitive threat to BeyfortusJefferies analysts suggest Merck may have its work cut out as it looks to introduce clesrovimab as a challenger in the space. "We argue Beyfortus has set a high efficacy bar, plus the long-term competitive threat is likely limited given its impressive real-world data and rapid clinical adoption," they said in a recent note to clients.The analysts also suggested that for clesrovimab to hamper Beyfortus' momentum, it would likely need to demonstrate a "notably greater reduction" in RSV lower respiratory tract infection (LRTI). Instead, they said "early trials suggest Merck's primary endpoint will likely be in-line… suggesting only minimal impact to our Beyfortus [worldwide] peak sales forecast" of €3.75 billion ($4.1 billion).According to Jefferies, a Phase I/IIa study of 64 infants showed that a 100-mg dose of clesrovimab reduced the risk of infection by 80.6% compared to a placebo through 150 days. Using a model-based analysis, they estimate that a single 100-mg dose would likely provide about 77.5% protection against LRTIs over that same length of time."We argue Merck's candidate must also show 80%-90% reduction in RSV-associated LRTI hospitalisation to be considered comparable, or at least 90% to be a notable threat to Beyfortus given recent impressive real-world data…published in The Lancet," they said.Besides Beyfortus, Pfizer's RSV vaccine Abrysvo is also approved for maternal use to protect infants. Abrysvo along with GSK's Arexvy, which so far is the market leader, and newcomer mRESVIA, made by Moderna, are approved for older adults as well. For more, see Vital Signs: RSV and pharma’s fastest drug launches.