Elasomeran

Dive Brief:GSK says it owns seven patents that provide the foundation for Modernas messenger RNA vaccine portfolio, and is now suing the biotechnology company for infringement.At issue is the work of a team led by Christian Mandl, who was a top official in the vaccines unit at Novartis between 2008 and 2015. According to the lawsuit, Mandls team discovered new formulations and methods of preparing mRNA vaccines, overcoming hurdles that had long prevented development of successful shots using the technology.The team filed for patents on their work in 2010. GSK then acquired that intellectual property when it took over much of Novartis vaccines business in 2015. Now, GSK is saying Modernas COVID-19 vaccines infringe those patents and is seeking damages. A Moderna spokesperson said the company is aware of the suit and will defend itself against the claims.Dive Insight:Moderna, along with rivals Pfizer and BioNTech, achieved an astonishing public health success by developing an mRNA vaccine to fight the COVID-19 pandemic in less than a year. The companies also earned billions of dollars, sparking a series of legal battles over the patents involved.Moderna sparred with the U.S. government over intellectual property claims early in the pandemic. In February 2022, Arbutus Biopharma and Genevant Sciences sued Moderna over patents related to the delivery of mRNA shots. Weeks later, Alnylam Pharmaceuticals sued both Moderna and Pfizer, claiming that the companies violated an Alnylam patent on lipid nanoparticle technology.The legal battles didnt stop there. Another mRNA specialist, CureVac, sued BioNTech in July 2022. The following month, Moderna sued Pfizer and BioNTech, which then evened the score a year later by asking the U.S. government to dismiss some of Modernas patents.Earlier this year, GSK also sued Pfizer and BioNTech, alleging infringement on different patents stemming from the work of Mandls team and former Novartis researcher, Andrew Geall.In the latest lawsuit, filed in federal court in Delaware, GSK says Moderna could not have succeeded in the lightning-quick development of its COVID-19 vaccine without the work of Mandls team.Moderna has repeatedly touted the speed at which it produced its original Spikevax vaccine and was later able to modify it to address new viral strains, GSK said. But Moderna has consistently failed to acknowledge how it applied the Mandl teams revolutionary platform to do so.GSK is asking a jury to award unspecified damages and a licensing fee for its patents. Its also seeking to be reimbursed for attorney fees and costs incurred in the lawsuit. '

Unlike Comirnaty and Spikevax, Kostaive is designed as a sa-mRNA vaccine which should boost a stronger response. Credits: Pormezz/Shutterstock.com CSL and Arcturus Therapeutics ’s self-amplifying mRNA (sa-mRNA) vaccine, Kostaive (ARCT-154) has been approved in Japan to tackle the JN.1 strain of Covid-19. The vaccine was approved by Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Meiji Seika Pharma will be responsible for distribution as part of the October 2024 Covid-19 vaccination campaign, said CSL’s SVP and Head of Global Regulatory Affairs, Emmanuelle Lecomte-Brisset. “We look forward to introducing Kostaive in Japan as a safe, tolerable and more durable option in protecting against Covid-19,” Lecomte-Brisset added in the 13 September announcement. JN.1 is a derivative of Omicron variant BA.2.86 and is characterised by an extra mutation in the spike protein. Like Pfizer and BioNTech ’s Comirnaty and Moderna ’s Spikevax, Kostaive is an mRNA vaccine designed to protect against Covid-19 by providing the body instructions on how to fight the disease. However, the sa-mRNA vaccine, Kostaive instructs the body to produce more mRNA and protein, promoting a stronger immune response. See Also: Sanofi signs radioligand therapy licensing deal for rare cancers EASD 2024: Are tetra-agonists the future of metabolic diseases treatment? According to GlobalData’s consensus forecasts, Kostaive is expected to generate total sales of $697m in 2030. GlobalData is the parent company of Pharmaceutical Technology . With its November 2023 approval in Japan, Kostaive became the first sa-mRNA Covid-19 vaccine to gain approval. The vaccine is intended for use in adults 18 years and older. The updated approval of Kostaive comes after a Japanese health ministry panel recommended in May that Covid-19 vaccines be updated to protect against the present subvariants of Omicron. The decisions also aligned with the World Health Organization’s (WHO) stance on updated vaccines. In August, Japan’s MHLW granted Moderna approval for an updated formulation of Spikevax targeting JN.1. Similar to Japan’s MHLW, on 5 June, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CDER) held a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the changes to implement to the US Covid-19 vaccines from 2024 to 2025. The committee was unanimous in their decision to update vaccines to target the JN.1 variant. Following the decision, the FDA granted updated versions of Comirnaty and Spikevax approval in late August. Free Whitepaper mRNA capping: low cost, high reward Are you aware of the latest mRNA capping techniques? The success of mRNA-based Covid vaccines has seen the technology boom in popularity – but capping is an essential part of the manufacturing process, and pharmaceutical firms face a range of choices on how to do it. This free whitepaper assesses differences in price, time, complexity and availability for the methods on offer – and provides essential insights on TriLink’s trailblazing CleanCap® approach. Fill in your details to find out more. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Trilink Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Trilink Thematic and that your personal data will be used as described in their Privacy Policy