Pediatric Multisystem Inflammatory Disease, COVID-19 Related

Pictured: Glass medical ampoule vial for injection and bottles with aluminum cap/istock, ivandan Novo Nordisk’s buy of Catalent remains a significant topic of conversation in the biotech world. While the CDMO’s latest quarterly numbers were down, analysts told BioSpace that Novo’s investment would help accelerate manufacturing for its GLP-1 receptor agonists Wegovy and Ozempic while limiting production capacity for competitors. “(Novo’s) biggest choke point and in getting Wegovy out there and competing against Lilly appears to be in sterile fill finish, and I’m sure this was a much quicker path for them,” Sean Dodge, an analyst at RBC Capital Markets, told BioSpace. “Buying all of this was a lot faster way to create new capacity than putting a shovel in the ground and creating something from scratch.” Max Smock, an analyst at William Blair, added that the deal does make sense as there is not a lot of prefilled syringe manufacturing capacity space available, and Novo bringing this in-house will allow the Danish pharma to have more control over the process. He also noted that the purchase of Catalent will enable Novo to get ahead of its competition. “You have these potential copycats coming into the market,” he told BioSpace. “You just took out a major CDMO that can fill out that drug product capacity.” Underwhelming Numbers On Friday of last week, Catalent’s second-quarter fiscal year 2024 results showed that the manufacturer pulled in net revenue of $1.03 billion, a 10% decrease from a year ago. Catalent said this was due to a drop in demand for COVID-19–related programs. Catalent also saw a 24% drop in net income from its biologics segment over the same period, reporting $446 million compared to $580 million the year prior. It was an “underwhelming quarter,” Smock told BioSpace. It’s not the first time the CDMO has announced disappointing financials, as its year-end report at the end of last year noted the company posted losses of $539 million and cut 1,100 jobs. But in terms of the company’s financial health, Sean Dodge, an analyst at RBC Capital Markets, told BioSpace that with 50 sites spread out all over the world, there is a lot of opportunity to grow its footprint and grow revenue. Catalent CEO Alessandro Maselli said in a statement that last week’s deal with Novo will help make that growth happen. “With the benefit of Novo Holdings’ expanded resources, we will be able to accelerate investment in our business and enhance key offerings for current and prospective pharma and biotech customers.” Smock noted that one area the Novo deal will help is in expanding Catalent’s capacity to make drug products such as prefilled syringes. In recent years, production of this type of drug has been a significant boon to Catalent’s bottom line, but the CDMO has had only has limited capacity and encountered issues in its manufacturing facility in Brussels, Reuters reported. In August 2023, Novo Nordisk had to call upon Thermo Fisher Scientific to manufacture Wegovy doses as demand rose and Catalent could not keep up. “I think the Novo acquisition acknowledges that [Catalent] can speed up some of the investments [the company] was looking to make in those areas,” Smock said. A Unique Situation Novo’s buy of Catalent is a unique situation in the CDMO space. “Novo needed a lot of capacity and relatively soon to support the massive volumes that will be coming down the pipe here on GLP-1s,” Brian Scanlan, a partner at Edgewater Captial Partners, wrote in an email to BioSpace. “Let’s not forget, the bulk of the new drugs in development are more niche, targeted therapeutics that require generally lower volumes. Companies focused in these type of therapeutics may not be too quick to buy up a bunch of capacity.” Dodge and Smock agreed. The deal runs “completely counter-current” to what big pharma has been doing for the past 15 years, Smock said. “You’re seeing [pharma] shift away . . . from having this capacity in-house; we would expect more outsourcing moving forward.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

THURSDAY, Jan. 18, 2024 -- Multisystem inflammatory syndrome in children (MIS-C) may be associated with an increased risk for future cardiovascular complications due to significant persistent vascular alterations, according to a research letter published online Jan. 16 in JAMA Pediatrics . Julie Boever, from Ludwig Maximilian University of Munich, and colleagues conducted a case-control study of 17 patients with MIS-C and 17 matched controls with a median follow-up of 114.5 days. The researchers found that during the acute phase, patients with MIS-C showed significantly damaged microcirculation, including lower median microvascular flow index (2.36 versus 2.80), total vessel density (16.14 versus 19.61 mm/mm 2 ), and proportion of perfused vessels (12.31 versus 18.10 percent) compared with controls. There was alteration of vessel diameter distribution with significant capillary rarefication. Even without ongoing inflammation, impaired microcirculatory parameters persisted during follow-up. These findings persisted when adjusting for age, body mass index, and sex. In MIS-C, the augmentation index was significantly increased only during follow-up (median, −7.05 versus −18.01). "This study emphasizes the importance of understanding the vascular impact of MIS-C during the acute phase and follow-up period to provide appropriate medical care and interventions," the authors write. Abstract/Full Text (subscription or payment may be required) Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Novavax's 2023-2024 season COVID vaccine candidate induced neutralizing responses to emerging subvariants EG.5.1 and XBB.1.16.6 in addition to XBB.1.5, XBB.1.16 and XBB.2.3 Upon regulatory approval, Novavax's COVID vaccine would be the only protein-based non-mRNA vaccine option available in key markets for the fall season GAITHERSBURG, Md., Aug. 22, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. XBB sublineage variants are overwhelmingly responsible for the majority of current COVID cases in the U.S. and European Union.1, 2 "Our data have shown that Novavax's protein-based COVID vaccine induces broadly neutralizing responses against XBB subvariants, including EG.5.1 and XBB.1.16.6," said Filip Dubovsky, President of Research and Development, Novavax. "We have a lot of confidence in our updated COVID vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall." Non-clinical data previously showed that Novavax's COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.3 Novavax is in the process of submitting applications for its XBB.1.5 COVID vaccine candidate to regulatory authorities globally. 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