BioNTech SE and Pfizer Inc disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.
The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
- Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply
- Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021
- BioNTech will contribute multiple mRNA vaccine candidates as part of its BNT162 COVID-19 vaccine program, which are expected to enter human testing in April 2020
- Pfizer will contribute its leading global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure and capabilities
- BioNTech will receive an upfront payment of $185 million, including an equity investment of approximately $113 million, and be eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million
The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance.
During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval.
“Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science – together – to bring forth a potential vaccine that the world needs as quickly as possible.”
“We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” says Co-Founder and CEO of BioNTech, Ugur Sahin, M.D.
Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Pfizer and BioNTech will share development costs equally. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine.
