BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021
September 17 2020 - 4:00AM
- Facility will become one of the largest mRNA manufacturing
sites in Europe and the third site in the BioNTech manufacturing
network in Germany expected to produce BNT162 for global
supply
- Expected to be fully operational in the first half 2021 with an
annual production capacity up to 750 million doses of potential
COVID-19 vaccine
- Rapid transition expected due to well-established biotechnology
drug substance and drug product manufacturing equipment as well as
an experienced team
- BioNTech will take over the entire site with currently
approximately 300 employees, enabling a rapid transition to BNT162
production upon transaction closing
MAINZ, Germany, September 17, 2020
(GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”
or “the Company”) today announced the signing of a share purchase
agreement with Novartis AG, Basel / Switzerland to acquire their
GMP certified manufacturing facility in Marburg, Germany. The
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. The transaction is
expected to close in the fourth quarter of 2020. The Company plans
to be able to produce up to 250 million doses of BNT162b2 in the
first half of 2021, thanks to the established team and
well-established drug substance and drug product manufacturing
capabilities at the site.
The Marburg production site is a
state-of-the-art, multi-platform GMP certified manufacturing
facility that currently employs approximately 300 people. It is
fully equipped for the production of recombinant proteins as well
as cell and gene therapies, and holds cell culture labs and viral
vector production capabilities, with further potential for
long-term growth and expansion. Novartis has significantly invested
in the site over the past five years, which is located in a life
science industry park that is home to more than 10 companies with
6,000 employees in total, and also provides an excellent
infrastructure for the Company. The industrial park is located
within one hour from the Frankfurt airport and within 90 minutes
from BioNTech’s headquarters in Mainz, Germany.
“This acquisition reflects BioNTech’s commitment
to significantly expanding its manufacturing capacity in order to
supply a potential vaccine worldwide upon authorization or
approval. We are working closely with Novartis to prepare for a
smooth transition, and we look forward to welcoming the new members
of our team and tapping into their impressive skills and expertise.
From a strategic standpoint, the new site will bolster our
vertically integrated business model with in-house manufacturing
capabilities for mRNA manufacturing as well as vaccine
formulation,” said Dr. Sierk Poetting, Chief Financial
Officer and Chief Operating Officer at BioNTech.
The acquisition will accelerate BioNTech’s
efforts to scale-up its commercial manufacturing capacity to
produce its mRNA COVID-19 vaccine candidate BNT162. The BNT162
program includes five mRNA vaccine candidates currently in clinical
testing in the United States, Europe, South America, and China.
BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in
a global Phase 3 trial.
The facility is expected to operate as one of
the largest mRNA manufacturing sites in Europe alongside two of
BioNTech’s existing GMP facilities which currently produce the
COVID-19 vaccine candidates for clinical trials, and in addition to
at least four Pfizer production sites in the United States and
Europe. The Marburg facility is expected to start the production of
mRNA and the LNP formulation for a COVID-19 vaccine in the first
half of 2021, pending regulatory authorization or approval.
BioNTech plans to manufacture additional therapeutic and vaccine
drug candidates at the plant, such as other mRNA vaccine, antibody,
and cell and gene therapy product candidates to support the
development of its diversified cancer and infectious disease
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, subject to regulatory authorization or approval.
The Marburg facility has a 100 years long
tradition of innovation: the manufacturing site, named
Behringwerke, was established in 1904 by Emil von Behring, who
developed the antitoxin for Diphtheria and Tetanus. He used the
award money he received with the Nobel Prize in Medicine in 1901 to
finance the manufacturing site. Since its founding in 1904, the
Behringwerke has been at the forefront of pharmaceutical and
biologic innovation, including the production of vaccines,
resulting in a highly established infrastructure.
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.
A presentation about the announcement will be
available here at 10 am CET.About
BioNTechBiopharmaceutical New Technologies is a next
generation immunotherapy company pioneering novel therapies for
cancer and other serious diseases. The Company exploits a wide
array of computational discovery and therapeutic drug platforms for
the rapid development of novel biopharmaceuticals. Its broad
portfolio of oncology product candidates includes individualized
and off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and
Pfizer.
For more information, please visit
www.BioNTech.de.BioNTech’s Forward-Looking
StatementsThis press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, BioNTech’s
efforts to combat COVID-19; the collaborations between BioNTech and
Pfizer and BioNTech and Fosun to develop a potential COVID-19
vaccine; the timing to close of the acquisition of the Marburg
facility; the manufacturing capacity of the Marburg facility; the
timeline for having the Marburg facility fully operational to
produce BNT162; the ability of the Marburg facility to produce mRNA
vaccine, antibody, and cell and gene therapy product candidates;
the ability of BioNTech to supply the quantities of BNT162 to
support clinical development and, if approved, market demand,
including our production estimates for 2020 and 2021; and the
timing of any potential regulatory submissions or receipt of any
potential emergency use authorizations or approvals. Any
forward-looking statements in this press release are based on
BioNTech management’s current expectations and beliefs of future
events, and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to:
competition to create a vaccine for COVID-19. For a discussion of
these and other risks and uncertainties, see BioNTech’s Annual
Report on Form 20-F filed with the SEC on March 31, 2020, which is
available on the SEC’s website www.sec.gov. All information in this
press release is as of the date of the release, and BioNTech
undertakes no duty to update this information unless required by
law.BioNTech Contacts Media
RelationsJasmina Alatovic+49 (0)6131 9084 1513 or +49
(0)151 1978 1385Media@biontech.de
Investor RelationsSylke Maas,
Ph.D.+49 (0)6131 9084 1074Investors@biontech.de
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