BioNTech to Receive up to €375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vacci...
September 15 2020 - 6:30AM
- The German Federal Ministry of Education and Research (BMBF)
COVID-19 initiative supports accelerated vaccine development, as
well as upscaling of manufacturing capabilities in Germany
- Five out of eight milestones defined in the BMBF funding for
the BNT162 vaccine program have already been achieved
- More than 28,000 participants have already been enrolled in the
Phase 3 clinical trial currently being conducted in the United
States, Brazil, Argentina and Europe
MAINZ, GERMANY, September 15,
2020 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today announced that it will receive a grant of up to 375
million Euro from an initiative by the German Federal Ministry of
Education and Research (BMBF) to support the accelerated
development of SARS-CoV-2 vaccines. BioNTech will use the
milestone-based BMBF funding to support its contribution to the
Company’s mRNA vaccine program BNT162 that is being co-developed
with its partners Pfizer Inc. and Fosun Pharma respectively. The
goal of the initiative is the expansion of vaccine development and
manufacturing capabilities in Germany, as well as the expansion of
the number of participants in late-stage clinical trials. The
BNT162 vaccine program is one of three programs supported by the
BMBF initiative, which will provide a total of up to 750 million
Euro to its funding recipients.
“We are grateful for the significant support
from the BMBF, which is helping us to provide a safe and effective
vaccine as soon as possible following regulatory approval. The
funding is an important contribution to accelerate the development
and scaling-up of our COVID-19 vaccine manufacturing capacities in
Germany. It highlights the tremendous importance of our mission to
efficiently find a lasting solution to control the pandemic,” said
Ugur Sahin, M.D., CEO and Co-founder of
BioNTech.
BioNTech will use the grant funding to cover its
expenses related to its COVID-19 vaccine program BNT162 within the
funded project in order to advance the clinical evaluation and
potential marketing authorisation as soon as possible. Pfizer
will continue to independently fund its share of development costs
for BNT162 without use of this or other government funding.
The milestones defined by the BMBF include the
preclinical evaluation of the vaccine candidates, the initiation
and implementation of clinical Phase 1 and Phase 2/3 trials (which
includes four clinical development milestones), the upscaling of
production capacities to supply the clinical trials and the general
population (pending marketing authorisation), and the submission
for regulatory approval as well as future marketing authorisation
of a vaccine. The Company has already achieved five of the eight
defined milestones. Most recently, BioNTech received approval from
the German regulatory authority, the Paul-Ehrlich-Institut, to
initiate the German arm of the global Phase 2/3 trial. Patient
recruitment has commenced on three continents and over 28,000
participants have already been enrolled worldwide with study sites
in the United States, Brazil, Argentina and Europe. Potential
marketing authorisation is dependent on the final outcome of the
ongoing late-stage clinical trials.
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, Regeneron, Genevant, Fosun Pharma, and
Pfizer.
For more information, please visit
www.BioNTech.de
BioNTech 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, statements
concerning: BioNTech’s efforts to combat COVID-19; the timing to
initiate clinical trials of BNT162, the size of its clinical trials
of BNT162, and anticipated publication of data from these clinical
trials; the potential safety and efficacy of BNT162; the timing for
any potential emergency use authorizations or approvals; and the
potential safety and efficacy of BNT162. 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: competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical results in larger and more diverse clinical trials; the
ability to effectively scale our productions capabilities; and
other potential difficulties. 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 at 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
- 200915_BioNTech_Press Release_BMBF_ENG_final
BioNTech Contacts:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513 or +49 (0)151 1978 1385
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
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