BioNTech and Pfizer have disclosed additional details of their collaboration to advance candidates from BioNTech's mRNA vaccine programme.
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.
Trials
The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the US 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 commercialise 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 of Worldwide Research, Development & Medical at Pfizer.
"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," said co-Founder and CEO of BioNTech, Ugur Sahin.
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 also 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% of the development costs, and BioNTech will repay Pfizer its 50% share of these costs during the commercialisation of the vaccine.