With weeks to go to COVID-19 vaccine trial, BioNTech lands $135M deal and advances Pfizer talks

BioNTech is in advanced talks with Pfizer over ex-China development of a coronavirus vaccine that is due to enter the clinic late next month. News of the progress of the vaccine and deal-making inside and outside of China sent shares in BioNTech up more than 50%.  

Germany’s BioNTech is part of a small group of mRNA companies that have long claimed their platforms cut the time it takes to develop vaccines in response to pandemic pathogens. Moderna, another member of the group, has already gone some way toward validating that idea by winning the race to get a SARS-CoV-2 vaccine in the clinic, while BioNTech’s compatriot CureVac has become the subject of a tug of war between the U.S. and German governments.

Now, BioNTech has provided more details of its own mRNA vaccine, BNT162. The biotech expects to start testing its SARS-CoV-2 vaccine in humans in late April. BioNTech plans to run a global program featuring study sites in Europe—initially in Germany—the U.S. and China. Talks with regulators around the world are well underway.

BioNTech is also putting in place the connections and infrastructure it will need to get the vaccine to patients in the event the clinical trial is a success. In conjunction with the disclosure of the clinical trial timeline, BioNTech revealed it is in advanced discussions with Pfizer about developing BNT162 outside of China.

Mikael Dolsten, chief scientific officer at Pfizer, disclosed the talks earlier this month. If the deal goes ahead, it will expand on a 2018 influenza agreement between the two companies. Back then, Pfizer paid $120 million upfront to collaborate with BioNTech on vaccines that use RNA encoding for an antigen to prime the immune system to identify and eliminate influenza viruses.

BioNTech’s partnering talks for within China are more advanced, with Fosun Pharma already signed up to commercialize BNT162 in the country. Fosun is set to pay BioNTech up to $135 million (€120 million) in “upfront and potential future investment and milestone payments.” In return, Fosun will share gross profits from sales of the vaccine in China. Fosun is making a $50 million investment in its new partner.

The deal gives BioNTech more than just money. BioNTech plans to leverage Fosun’s Chinese clinical trial, regulatory and commercial capabilities to speed the vaccine to patients in the country. Pfizer may play a similar role in the rest of the world, with BioNTech highlighting the need to bring partners on board to “ramp up production for global supply.”

BioNTech will manufacture BNT162 at its European mRNA manufacturing facilities with the support of its CDMO partner Polymun. However, global demand for an authorized SARS-CoV-2 vaccine could be huge, necessitating the coordination of other facilities to ensure fast access to the product. 

Shares in BioNTech rose more than 50% at points in premarket trading, causing its stock to change hands above its all-time high.