Saturday, July 13, 2024

COVID-19 and Influenza mRNA Vaccines: GSK Secures Global Rights in €1.45 Billion Agreement with CureVac

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The new licensing agreement with CureVac grants GlaxoSmithKline (GSK) global rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19, including combination vaccines. In return, CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory, and sales milestone payments, as well as tiered royalties. This new agreement replaces all previous financial arrangements from their prior collaboration.

Since their partnership began in 2020, GSK and CureVac have collaborated to advance mRNA vaccines for infectious diseases. This collaboration has yielded promising vaccine candidates for seasonal influenza and COVID-19, which are currently in phase II clinical development, and avian influenza, in phase I. These candidates leverage CureVac’s proprietary second-generation mRNA technology, showing potential to become best-in-class vaccines based on the data generated to date.

Under the restructured agreement, GSK will take full responsibility for the development and manufacturing of these vaccine candidates. Additionally, GSK will hold worldwide commercialization rights. This move aligns with GSK’s strategy of investing in vaccine platform technologies and matching the best platform to each pathogen to develop superior vaccines. The adaptability of mRNA technology, which supports rapid strain changes, makes it particularly suitable for addressing emerging and evolving viral pathogens. GSK continues to enhance its mRNA capabilities through investments and partnerships in areas such as AI/ML-based sequence optimization, nanoparticle design, and manufacturing.

CureVac Gains €1.45 Billion Deal with GSK to Advance COVID-19 and Influenza mRNA Vaccines

The agreement represents a significant step forward for both companies. CureVac will benefit from an upfront payment of €400 million, along with potential additional payments of up to €1.05 billion tied to development, regulatory, and sales milestones. The new financial terms also include tiered royalties ranging from high single digits to low teens. Furthermore, CureVac retains exclusive rights to undisclosed and preclinically validated infectious disease targets from the prior collaboration, allowing them the freedom to independently develop and partner mRNA vaccines for other infectious diseases or indications. Notably, CureVac’s ongoing patent litigation against Pfizer/BioNTech remains unaffected by this new agreement.

Tony Wood, Chief Scientific Officer at GSK, expressed enthusiasm about the potential of the flu and COVID-19 programs. He highlighted the opportunity to develop best-in-class mRNA vaccines that could change the standard of care by applying GSK’s extensive capabilities, partnerships, and intellectual property to CureVac’s technology.

Alexander Zehnder, Chief Executive Officer at CureVac, emphasized the instrumental role of the collaboration with GSK in developing promising, late-stage vaccine candidates leveraging their proprietary mRNA platform. He noted that the new licensing agreement strengthens CureVac’s financial position and enables a focused effort on building a robust R&D pipeline.

COVID-19

GSK and CureVac Partnership Set to Transform mRNA Vaccine Development Pending Regulatory Approvals

The completion of this new agreement is subject to certain antitrust and regulatory approvals, as well as customary closing conditions. The restructuring signifies a strategic realignment, allowing both companies to prioritize their respective mRNA development activities and leverage their strengths to advance innovative medical solutions.

By integrating their resources and expertise, GSK and CureVac aim to expedite the development of mRNA vaccines, addressing significant unmet needs in infectious disease prevention. This collaboration exemplifies the potential of strategic partnerships in driving medical innovation and improving public health outcomes on a global scale. As both companies continue to navigate the regulatory landscape and secure necessary approvals, the partnership is poised to make substantial contributions to the field of mRNA-based therapeutics.

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With this new licensing agreement, GSK and CureVac are set to enhance their market presence and impact in the rapidly evolving landscape of mRNA vaccine development, promising to deliver advanced solutions that could transform the future of infectious disease management.

 

Resource: GlaxoSmithKline, July 03, 2024

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