BioNet’s Recombinant Pertussis Vaccine Submitted to European Medicines Agency (EMA)
30 Julio 2024 - 11:00PM
Business Wire
“Monovalent recombinant acellular pertussis vaccine proven to
significantly boost immunity against pertussis”
BioNet Europe, the French subsidiary of BioNet, a vaccine
manufacturer specializing in the development of genetically
engineered vaccines, has announced the submission of a centralized
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) for its monovalent Recombinant Pertussis Vaccine
(RPV).
BioNet’s stand-alone vaccine targets whooping cough, a highly
contagious respiratory disease on the steep rise across Europe.
This non-combined vaccine is tailored to the persons who require
pertussis-only booster vaccination and are up-to-date with their
diphtheria and tetanus immunizations.
Dr Giuseppe Del Giudice, Director Translational Research at
BioNet, stated, “BioNet’s recombinant vaccine is designed to
provide more effective and longer-lasting immune protection against
pertussis than traditional acellular pertussis vaccines. It
contains a Pertussis Toxin (PT), the main component responsible for
severe pertussis disease, which is inactivated by recombinant
technologies rather than chemicals.”
These recombinant technologies allow for the preservation of the
native structure of the PT, fundamental for the induction of higher
immune protection. Currently, no other monovalent or recombinant
pertussis vaccines are available in Europe, making BioNet’s RPV a
best-in-class vaccine driving significant advancement in public
health with the potential to improve acceptance for pertussis
immunization.
Phillippe Guillot-Chene, CEO of BioNet Europe, added, “We
believe that BioNet’s RPV represents a transformative vaccine for
preventing pertussis disease. After receiving the positive feedback
from EMA Scientific Advice, we are honored to have our MAA
submission validated by the EMA as well.”
The safety, immunogenicity and antibody persistence induced
after one single booster dose of BioNet’s RPV were demonstrated in
numerous randomized clinical trials, notably amongst adults in
Australia, adolescents in Switzerland, as well as vulnerable
populations such as pregnant women and elderly in Thailand.
The vaccine is licensed in Asia (under the Pertagen® trademark)
and is included in the pertussis maternal immunization program for
pregnant women in Thailand. The MAA of Pertagen® has also been
submitted to the Australian Therapeutic Goods Administration.
About BioNet
BioNet is a vaccine manufacturer specializing in the development
of recombinant and mRNA vaccines against respiratory diseases and
other global public health threats. BioNet has a strong track
record with development and biomanufacturing, having advanced over
three proprietary recombinant pertussis vaccines from early R&D
to licensure. It currently markets multiple vaccines through its
established commercial network. BioNet has been rapidly expanding
its operations across Asia, Europe and North America.
Forward-Looking Statements
This press release contains forward-looking statements relating
to BioNet’s business, including regulatory submissions. These
statements are based on current expectations as of the date of this
press release and involve known and unknown risks and uncertainties
that may cause actual results to differ materially. BioNet
disclaims any intention or obligation to publicly update or revise
any forward-looking statements, whether due to new information,
future events, or otherwise.
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Media Contacts Europe: Benoit Soubeyrand,
bsoubeyrand@bionet.one Asia-Pacific: Laurent Dapremont,
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