Update on First BioNTainer for African-based mRNA Manufacturing Facility
December 21 2022 - 8:45AM
Update on First BioNTainer for African-based mRNA Manufacturing
Facility
MAINZ, GERMANY, December 21, 2022 —
BioNTech SE (Nasdaq: BNTX, “BioNTech”) reached the next milestone
in the establishment of scalable mRNA vaccine production in Africa.
The six ISO-sized shipping containers for the first BioNTainer have
finished construction in Europe, underwent quality checks by
BioNTech experts and are being prepared for shipment to Kigali,
Rwanda, where they are expected to arrive in the first quarter of
2023. Media material from the preparation is now available
here.
In parallel, BioNTech continues to develop and
build its state-of-the-art manufacturing facility in Kigali,
Rwanda, following the groundbreaking in June 2022. The facility
will be housing the first BioNTainers and is expected to become a
node in a decentralized and robust end-to-end manufacturing network
in Africa. BioNTech also expects to ship BioNTainers to Senegal and
potentially South Africa in close coordination with each respective
country and the African Union. Vaccines to be manufactured in this
Africa-wide network will be dedicated to people residing in member
states of the African Union, with the aim to support access to
novel medicines.
In addition, BioNTech is advancing mRNA-based
vaccine candidates to address malaria and tuberculosis, based on
the company’s mRNA platform. The vaccine candidates are expected to
enter first-in-human trials in late 2022 or early 2023.
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, Genentech, a member of the Roche Group,
Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit
www.BioNTech.com.
Forward-looking statementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements may include, but may not be limited to,
direct or indirect statements concerning: the ability of BioNTech
to produce, deliver and install mRNA container manufacturing
facilities for the African continent, including the ability to meet
all necessary infrastructure, technology and regulatory
requirements; potential delays in the establishment of the
BioNTainers and BioNTech operations in Africa, due to unforeseen
delays, including, but not limited to, global supply chain issues;
the ability of BioNTech to reach an agreement with potential
collaboration partners in Africa to establish an end-to-end
manufacturing network in Africa; the development of quality
assurance capabilities to remotely support manufacturing sites in
Africa; the scale-up of local know-how and training in Africa;
BioNTech’s malaria, tuberculosis and other infectious disease
vaccine development programs; timing for selecting clinical
candidates for these programs and the commencement of a clinical
trial, as well as any data readouts; the nature of the
collaboration with the African Union, the Africa CDC, and the WHO;
the development of sustainable RNA vaccine capacities, production
and supply solutions on the African continent and the nature,
timing, and feasibility of these solutions; the potential safety
and efficacy of the product candidates; and BioNTech’s anticipated
market opportunity and size for its product candidates the rate and
degree of market acceptance of BioNTech’s investigational
medicines, if approved; BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine (including qualitative assessments of available data,
potential benefits, expectations for clinical trials, supply
agreements and the timing of delivery of doses thereunder, efforts
to help ensure global equitable access to the vaccine, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply). Any forward-looking statements in this press release are
based on BioNTech 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:
discussions with regulatory agencies regarding timing and
requirements for additional clinical trials; and the ability to
produce comparable clinical results in future clinical trials.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the
quarter ended September 30, 2022, filed with the SEC on November 7,
2022, which is available on the SEC’s website at
http://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.
CONTACTS
Investor Relations Sylke Maas, Ph.D. VP Investor
Relations & Strategy +49 (0)6131 9084 1074
Investors@biontech.de
Media Relations Jasmina Alatovic VP Corporate
Communications +49 (0)6131 9084 1513 Media@biontech.de
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