BioNTech To Acquire Novartis Mfg Site, Increase COVID Vaccine Production
BioNTech, a Mainz, Germany-based immunotherapy company, which is partnered with Pfizer for the development of a COVID-19 vaccine, has signed a purchase agreement with Novartis to acquire Novartis’ manufacturing facility in Marburg, Germany to expand its COVID-19 vaccine production capacity. The company also reported a grant of up to EUR 375 million ($445 million) from the German government to fund development and manufacturing of its COVID vaccines.
The acquisition of the Novartis manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. BioNTech says it plans to be able to produce up to 250 million doses of its mRNA vaccine candidate developed with Pfizer, BNT162b2, in the first half of 2021. The facility has both drug-substance and drug-product manufacturing capabilities. BNT162b2 is one of four mRNA vaccine candidates being developed with Pfizer and is the most advanced in Phase III trials.
The site, which currently employs approximately 300 people, is equipped for the production of recombinant proteins as well as cell and gene therapies and has cell-culture labs and viral vector production capabilities. The site adds to BioNTech’s and Pfizer’s manufacturing network for its COVID-19 vaccine, which includes two BioNTech’s GMP facilities in Europe and which currently produce the COVID-19 vaccine candidates for clinical trials, and at least four Pfizer production sites in the US and Europe.
The Marburg facility is expected to start the production of mRNA and the lipid nanoparticle formulation for a COVID-19 vaccine in the first half of 2021, pending regulatory authorization or approval. BioNTech says it plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibodies, and cell and gene therapies, from its product pipeline. In addition, BioNTech intends to use the Marburg facility to contribute to the production of the COVID-19 vaccine for global supply, including to China, where it is partnered with Fosun Pharma, a Shanghai-based biopharmaceutical company.
BioNTech and Novartis anticipate completing the transaction in the fourth quarter of 2020, subject to regulatory approval and the satisfaction of certain other customary closing conditions.
Funding up to $445 M from German gov’t
The pending acquisition of the Novartis manufacturing site follows the award of a grant of up to EUR 375 million ($445 million) from the German Federal Ministry of Education and Research to support COVID-19 vaccine development and manufacturing.
The BNT162 vaccine program is one of three programs supported by the German government, which will provide a total of up to EUR 750 million ($889 million) to its funding recipients.
The milestones include the preclinical evaluation of the vaccine candidates, the initiation and implementation of clinical Phase I and Phase II/III trials (which includes four clinical development milestones), the upscaling of production capacities to supply clinical trials and supply for general population (pending marketing authorization), the submission of regulatory filings and future marketing authorization of a vaccine. The company has already achieved five of the eight defined milestones.
Phase III trial enrollment proceeding
Most recently, BioNTech received approval from the German regulatory authority, the Paul-Ehrlich-Institut, to initiate the German arm of a global Phase II/III trial. Over 28,000 participants have already been enrolled worldwide with study sites in the US, Brazil, Argentina, and Europe. In addition, Pfizer and BioNTech have submitted an amended protocol to the US Food and Drug Administration (FDA) to expand the enrollment of their Phase III COVID-19 vaccine trial to up to approximately 44,000 participants.
Enrollment in the trial has been proceeding as planned and the companies say they expects to reach the initial target of up to 30,000 participants in September (September 2020). The proposed expansion would allow the companies to further increase trial population diversity and include adolescents as young as 16 years of age and people with chronic, stable HIV hepatitis C or hepatitis B infection, as well as provide additional safety and efficacy data. The companies say they continue to expect that a conclusive readout on efficacy is likely by the end of October (October 2020).