Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021.
Production will take place in a new high-tech production facility that was already under construction at the Novartis Kundl, Austria site. This will be adapted to the needs of messenger RNA vaccine production for CureVac’s CVnCoV, the manufacturing of which is highly complex. Novartis plans to produce up to 50 million doses of the mRNA and bulk drug product for the CureVac vaccine in 2021 and up to a further 200 million doses in 2022. The bulk drug product will then be delivered to CureVac for further processing and filling.
“We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand”, said Steffen Lang, Global Head of Novartis Technical Operations and member of the Novartis Executive Committee.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, said: “I am very pleased that with Novartis we have found another highly experienced partner to support the production of our vaccine candidate. Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base.”
Novartis response to the COVID-19 pandemic
Novartis is making a number of contributions to the global fight against the COVID-19 pandemic and supporting the stability of global health systems. The company recently announced an initial agreement with BioNtech to provide manufacturing capacity for a COVID19 vaccination at its site in Stein, Switzerland. Novartis is committed to donating US $40 million to help communities affected by the pandemic around the world. In addition, Novartis is active in several key cross-industry research initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard as well as a COVID-19 directed partnership supported by the Innovative Medicines Initiative (IMI). Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. The company is separately supporting COVID-19-related clinical investigations of several Novartis medicines. In our labs, we have started a collaborative, longer-term drug discovery effort to develop first oral medicines for COVID-19 and other coronaviruses. To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines. We are making 15 drugs that treat key symptoms of COVID-19 available to low-and lower-middle income countries at zero profit until a vaccine or curative treatment is available. Furthermore, Novartis Gene Therapies entered into a manufacturing agreement with Massachusetts Eye and Ear and Massachusetts General Hospital to produce its novel genetic COVID-19 vaccine candidate called AAVCOVID8. More information about the Novartis response to COVID-19 is available at www.novartis.com/COVID-19
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plans,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “to provide,” “aspires,” “intends,” “to produce,” or similar terms, or by express or implied discussions regarding our agreement to manufacture the mRNA bulk drug product for the COVID-19 vaccine candidate CVnCOV from CureVac or regarding potential future revenues from such agreement. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that our manufacturing of the mRNA bulk drug product will be successful. Nor can there be any guarantee that our agreement with CureVac will be commercially successful. In particular, our expectations regarding the manufacture of the mRNA bulk drug product for the COVID-19 vaccine candidate CVnCOV could be affected by, among other things, the uncertainties inherent in the manufacturing process of the mRNA bulk drug product; safety, quality, data integrity or manufacturing issues; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com .
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