GSK, CureVac in Vaccine Pact for COVID-19 Variants; Form Mfg Pacts

GlaxoSmithKline (GSK) and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, have entered into a EUR 150-million ($180-million) pact to jointly develop mRNA vaccines for COVID-19 to address multiple emerging variants in one vaccine. CureVac is already progressing a COVID-19 vaccine and has formed separate manufacturing pacts with GSK and Bayer for the vaccine.

Through a new exclusive co-development agreement, GSK and CureVac will develop, and manufacture a number of mRNA vaccine candidates to address COVID-19 variants, including multivalent and monovalent approaches. The aim of this work is to offer broader protection against a variety of different SARS-CoV2 variants and to enable a quick response to new variants potentially emerging in the future.

The development program will begin immediately (as reported on February 3, 2021), with the target of introducing the vaccine in 2022, subject to regulatory approval. GSK will be the marketing authorization holder for the vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialize the COVID-19 vaccine in all countries with the exception of Germany, Austria ,and Switzerland. GSK will make an upfront payment of EUR 75 million ($90 million) and a further milestone payment of EUR 75 million ($90 million), conditional on the achievement of specific milestones.

Manufacturing pacts

CureVac has already developed a “first-generation” COVID-19 vaccine CVnCoV, which is currently in Phase IIb/III clinical trials. GSK says it will support the manufacture of CVnCoV for up to 100 million doses in 2021 using its manufacturing network in Belgium.

In addition, Bayer reports it will supply 160 million doses of CureVac’s, COVID-19 vaccine in 2022. In January (January 2021), the companies formed a pact to further develop and supply CureVac’s COVID-19 vaccine. Bayer now reports it will use its product supply network, including its site in Wuppertal, Germany. Bayer says the first commercial product from this expansion may be available toward the end of this year (2021).

Additionally, Rentschler Biopharma, a Laupheim, Germany-based biologics CDMO and CureVac have initiated the set-up of manufacturing capabilities for CureVac´s COVID-19 vaccine, CVnCoV. Rentschler Biopharma is gearing up for large-scale cGMP (production of the formulated mRNA for CVnCoV. Rentschler Biopharma will contribute to the manufacturing of the active pharmaceutical ingredient, downstream processing, and the formulation of the drug substance for the vaccine. The companies entered into a collaboration in November 2020 with the set-up of dedicated production lines at Rentschler Biopharma’s site in Laupheim, Germany. The companies expect to produce more than 100 million doses of the CureVac vaccine per year in the Laupheim site.

CureVac raises $450 million

In a separate development, CureVac reported that it had raised approximately $450 million through a public offering of 5 million common shares, at a price of $90.00 per common share, for total gross proceeds of approximately $450 million.

Source: GlaxoSmithKline, Bayer, Rentschler Biopharma, CureVac (GSK), CureVac (Rentschler) and CureVac (public offering)

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