Latest news with #mRESVIA®
Yahoo
03-03-2025
- Business
- Yahoo
Genevant Sciences and Arbutus Biopharma Initiate International Patent Infringement Enforcement Actions Against Moderna
BASEL, Switzerland and VANCOUVER, B.C. and WARMINSTER, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio (a subsidiary of Roivant Sciences, Ltd. (Nasdaq: ROIV)), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, Inc. and certain affiliates. Together, the enforcement actions target alleged infringing activities in 30 countries. Genevant and Arbutus are seeking monetary relief and injunctions against Spikevax® and, where applicable, additional Moderna products that Moderna has represented use the same LNP technology, including mRESVIA®. Where permitted to do so at this stage, Genevant and Arbutus submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe indicating that the samples contain LNPs falling under the protective scope of the claims of their lipid composition patents. The cases are: Canada: Federal Court of Canada File No. T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna's profits, attributable to infringement of Canadian Patent No. 2,721,333. Japan: Tokyo District Court Case No. 2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No. 5,475,753. Switzerland: filing a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254. Unified Patent Court (UPC): Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 2 279 254. UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 4 241 767. The UPC actions together seek relief for: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey. Today's actions expand on Arbutus and Genevant's ongoing enforcement proceeding in the U.S. District Court for the District of Delaware, seeking fair compensation for Moderna's alleged infringement of six U.S. patents in the manufacture and sale of Spikevax®. A jury trial is currently scheduled for September 2025. It is well established in the scientific literature that the most significant technological hurdle to developing and deploying medicines using mRNA is engineering a safe and effective way to deliver the mRNA to human cells. Scientists at Arbutus and Genevant have spent years developing and refining LNP delivery technology, which has been licensed for various applications to many different third parties, including Moderna. Arbutus and Genevant's LNP technology relies on microscopic particles built from four carefully selected types of fat-like molecules to shelter and protect mRNA molecules and to enable them to travel through the human body to a target cell and through the target cell's membrane before releasing the mRNA. Without this crucial delivery technology, mRNA would quickly degrade in the body and be ineffective. About Genevant Sciences Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant's scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant's LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Through its ownership stake in and license agreement with Genevant, Arbutus is also focused on maximizing opportunity for its in-house developed Lipid Nanoparticle (LNP) delivery technology. For more information, visit Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about: Arbutus' plans with respect to the ongoing patent litigation matters. Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. CONTACT: Contact: Pete Zorn
Associated Press
03-03-2025
- Business
- Associated Press
Genevant Sciences and Arbutus Biopharma Initiate International Patent Infringement Enforcement Actions Against Moderna
BASEL, Switzerland and VANCOUVER, British Columbia and WARMINSTER, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio (a subsidiary of Roivant Sciences, Ltd. (Nasdaq: ROIV)), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, Inc. and certain affiliates. Together, the enforcement actions target alleged infringing activities in 30 countries. Genevant and Arbutus are seeking monetary relief and injunctions against Spikevax® and, where applicable, additional Moderna products that Moderna has represented use the same LNP technology, including mRESVIA®. Where permitted to do so at this stage, Genevant and Arbutus submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe indicating that the samples contain LNPs falling under the protective scope of the claims of their lipid composition patents. The cases are: Canada: Federal Court of Canada File No. T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna's profits, attributable to infringement of Canadian Patent No. 2,721,333. Japan: Tokyo District Court Case No. 2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No. 5,475,753. Switzerland: filing a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254. Unified Patent Court (UPC): Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 2 279 254. UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 4 241 767. The UPC actions together seek relief for: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey. Today's actions expand on Arbutus and Genevant's ongoing enforcement proceeding in the U.S. District Court for the District of Delaware, seeking fair compensation for Moderna's alleged infringement of six U.S. patents in the manufacture and sale of Spikevax®. A jury trial is currently scheduled for September 2025. It is well established in the scientific literature that the most significant technological hurdle to developing and deploying medicines using mRNA is engineering a safe and effective way to deliver the mRNA to human cells. Scientists at Arbutus and Genevant have spent years developing and refining LNP delivery technology, which has been licensed for various applications to many different third parties, including Moderna. Arbutus and Genevant's LNP technology relies on microscopic particles built from four carefully selected types of fat-like molecules to shelter and protect mRNA molecules and to enable them to travel through the human body to a target cell and through the target cell's membrane before releasing the mRNA. Without this crucial delivery technology, mRNA would quickly degrade in the body and be ineffective. About Genevant Sciences Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant's scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant's LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Through its ownership stake in and license agreement with Genevant, Arbutus is also focused on maximizing opportunity for its in-house developed Lipid Nanoparticle (LNP) delivery technology. For more information, visit Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about: Arbutus' plans with respect to the ongoing patent litigation matters. Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Yahoo
28-02-2025
- Health
- Yahoo
Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine
mRESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. "The MHRA's authorization of our RSV vaccine is an important milestone for Moderna's efforts toward respiratory disease preparedness," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our RSV vaccine will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year." RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. In the UK, RSV has an impact on elderly adults and is responsible for 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths in adults 65 years of age and older per year.[i] "Given the serious consequences of RSV for older people, which can lead to hospitalization and severe outcomes, we are delighted that the MHRA has authorized our RSV vaccine," said Darius Hughes, UK General Manager of Moderna. "With the MHRA decision, mRESVIA becomes Moderna's second approved product in the UK, further demonstrating the role of mRNA vaccines in helping to protect the public from respiratory diseases." The approval is based on positive data from the Phase 3 clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. No serious safety concerns were identified in the Phase 3 trial. About mRNA-1345 (Respiratory Syncytial Virus Vaccine) mRNA-1345 is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. To date, Moderna has received marketing authorizations for its RSV vaccine in the United States, the European Union, Canada, Qatar, the United Arab Emirates, and Taiwan and has submitted regulatory applications in other markets worldwide. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the vaccine efficacy and safety of mRNA-1345; the potential for mRESVIA to reduce disease burden from RSV; Moderna's expectation that the MITC will be fully operational later this year; and Moderna's regulatory applications worldwide. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts International Media:Luke Mircea-WillatsSenior Director, International UK Media:Emma Gilgunn-JonesDirector, UK Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 1. Fleming, D.M., Taylor, R.J., Lustig, R.L. et al. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis 15, 443 (2015). SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire Sign in to access your portfolio
