J&J and Emergent BioSolutions Strike Manufacturing Deal for COVID-19 Vaccine Candidate
Less than one month after Johnson & Johnson identified a lead vaccine candidate against COVID-19, the life sciences giant announced an agreement with Emergent BioSolutions to support the manufacturing needs for the potential medication.
Late Thursday, the two companies signed a deal worth about $135 million to manufacture more than one billion doses of the potential vaccine candidate. Under terms of the agreement, Maryland-based Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021. A longer-term commercial manufacturing agreement for large-scale drug substance manufacturing anticipated to begin in 2021, the company said in its announcement.
Robert G. Kramer, president and chief executive officer of Emergent BioSolutions, touted the partnership with J&J as a potential solution to the pressing need for a vaccine against COVID-19, the pandemic that has shut down much of the world’s economies.
“At a time like this, we all need to be working together to achieve maximum results for public health. Emergent is committed to our mission – to protect and enhance life – by advancing our own therapies and helping partner companies advance their programs as well,” Kramer said in a statement.
At the end of March, Johnson & Johnson announced it had identified a lead vaccine candidate and was eying September for the start of clinical trials. J&J’s COVID-19 vaccine program will leverage subsidiary Janssen's proven AdVac and PER.C6 technologies that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the company's Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates which are in Phase II and Phase III.
The goal of one billion doses of the potential vaccine came about from an agreement J&J struck with the Biomedical Advanced Research and Development Authority (BARDA) that supports the rapid scaling of vaccine manufacturing. As part of that agreement, J&J and the government agency have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing of vaccines.
There are currently more than 70 vaccine candidates being assessed for COVID-19. Only a handful of the candidates have moved into human trials, with CanSino’s Adenovirus Type 5 Vector, Ad5-nCoV, being the farthest along in Phase II studies.
Emergent said large-scale manufacturing of the vaccine candidate will be conducted at the company’s Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM), which is designed for the rapid manufacture of large quantities of vaccines. Emergent established the manufacturing facility through a public-private partnership with the U.S. Department of Health and Human Services. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used, the company said.
Syed T. Husain, head of Emergent’s CDMO business, noted that the company will leverage its abilities and capacities up to 300 million doses to advance this much-needed vaccine candidate and ensure ongoing commercial supply through our CDMO services.
Emergent’s stock has climbed more than 7% in premarket trading.