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GSK and CureVac to Restructure Collaboration into New Licensing Agreement

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GSK and CureVac have restructured their existing collaboration into a new licensing agreement. GSK will acquire full rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19 globally. CureVac will receive an upfront payment of €400 million, and up to an additional €1.05 billion in milestone payments, along with tiered royalties. This new agreement supersedes any previous financial terms from their prior collaboration. The candidate vaccines are in various stages of clinical development and utilize CureVac's second-generation mRNA technology. GSK aims to leverage its capabilities to advance these vaccines, while CureVac retains rights to develop other mRNA vaccines independently. The agreement is subject to antitrust and regulatory approvals.

Positive
  • GSK acquires full rights to develop and commercialize mRNA vaccines for flu and COVID-19.
  • CureVac receives €400 million upfront, plus up to €1.05 billion in milestone payments and tiered royalties.
  • The new agreement supersedes previous financial terms, offering potential financial stability to CureVac.
  • Candidate vaccines are in advanced clinical stages, indicating progress in development.
  • GSK continues to invest in mRNA technology, enhancing their vaccine development capabilities.
Negative
  • Agreement completion is subject to antitrust and regulatory approvals, posing potential delays or risks.

Insights

The restructuring of the collaboration between GSK and CureVac into a new licensing agreement includes significant financial terms. CureVac will receive an €400 million upfront payment and up to €1.05 billion in additional milestone payments. These milestones are based on development, regulatory and sales achievements, complemented by tiered royalties in the high single to low teens range.

For GSK, acquiring full rights to develop, manufacture and commercialize globally their mRNA candidate vaccines for influenza and COVID-19 aligns with their strategic focus on mRNA vaccine technology. This move represents a substantial investment in their vaccine platform technologies, incorporating advanced techniques such as AI/ML-based sequence optimization and nanoparticle design. These investments will likely bolster GSK's position in the competitive mRNA vaccine market.

For retail investors, this agreement should be viewed positively for both companies: CureVac secures a strong financial position with immediate and potential future revenue and GSK strengthens its vaccine pipeline. However, it is essential to consider the conditional factors such as the antitrust and regulatory approvals that are yet to be completed.

The new agreement between GSK and CureVac highlights the promising mRNA technology platform, with vaccine candidates for seasonal influenza and COVID-19 already in Phase 2 clinical trials. GSK's control over the development and manufacturing process emphasizes their confidence in the potential of these vaccines to be best-in-class. The adaptability of mRNA technology, which enables rapid strain changes, is important for developing vaccines against emerging viral pathogens.

For CureVac, retaining exclusive rights to additional preclinically validated infectious disease targets allows them to focus on enhancing their R&D pipeline. This restructuring reflects a strategic pivot to maximize each company's core competencies. Investors should remain attentive to the progress of these clinical trials and subsequent regulatory approvals, as these will be key indicators of the vaccines' market potential.

  • GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations

  • CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced

LONDON, UK, TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / July 3, 2024 / GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq:CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities.

Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development. All candidates are based on CureVac's proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

Under the terms of the new agreement, GSK will assume full control of developing and manufacturing these candidate vaccines. GSK will have worldwide rights to commercialise the candidate vaccines. The agreement represents the latest step in GSK's ongoing investment in vaccine platform technologies, matching the best platform to each pathogen to develop best-in-class vaccines. mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change. GSK continues to develop and optimize its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.

CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory and sales milestones and tiered royalties in the high single to low teens range. The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac. CureVac further retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA vaccines in any other infectious disease or other indication. CureVac's ongoing patent litigation against Pfizer/BioNTech is unaffected by the new agreement.

Tony Wood, Chief Scientific Officer, GSK said: "We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK's capabilities, partnerships and intellectual property to CureVac's technology, to deliver these promising vaccines at pace."

Alexander Zehnder, Chief Executive Officer, CureVac said: "The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform. This new licensing agreement puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline."

Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.


CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

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Forward-Looking Statements CureVac

This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," or "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

SOURCE: CureVac



View the original press release on accesswire.com

FAQ

What is the new licensing agreement between GSK and CureVac?

The new licensing agreement allows GSK to acquire full rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19.

How much will CureVac receive under the new agreement with GSK?

CureVac will receive €400 million upfront and up to an additional €1.05 billion in milestone payments, along with tiered royalties.

What are the clinical development stages of the vaccines under the GSK and CureVac collaboration?

The vaccines for seasonal influenza and COVID-19 are in Phase 2, while the vaccine for avian influenza is in Phase 1 clinical development.

What technology is being used in the candidate vaccines developed by GSK and CureVac?

The candidate vaccines are based on CureVac's proprietary second-generation mRNA technology.

Will CureVac retain any rights under the new agreement with GSK?

Yes, CureVac retains exclusive rights to additional undisclosed and preclinically validated infectious disease targets and has the freedom to develop and partner mRNA vaccines in other indications.

What is the stock symbol for CureVac?

The stock symbol for CureVac is CVAC.

Are there any approvals required for the completion of the new agreement between GSK and CureVac?

Yes, the completion of the new agreement is subject to certain antitrust and regulatory approvals and customary closing conditions.

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