BiondVax is Declared “A Good Manufacturing Practice (GMP) Company” After Passing European Qualified Person (QP) Audit; BiondVax Signs Agreement to Collaborate With MonoSol on Developing Oral Delivery for Universal Flu Vaccine M-001
NES ZIONA, Israel, October 22, 2012 /PRNewswire/ –
BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced that the Company has passed
successfully a 2 day QP GMP audit during which the Company`s manufacturing facility,
production process, personnel and quality control procedures were examined in great
detail. This demanding certification is a requirement for Companies intending to
manufacture a clinical grade product for human trials anywhere in Europe and gives the
Company the go-ahead to advance clinical development of its universal flu vaccine, M-001,
in the EU.
BiondVax Pharmaceuticals Ltd. also announced that the Company will conduct
collaborative studies with MonoSol Rx located in New Jersey, USA, to investigate the
activity of BiondVax’s universal influenza vaccine, M-001, when formulated utilizing
MonoSol Rx’s PharmaFilm(R) technology for administration by mouth. The multiple advantages
of an oral universal influenza vaccine include ease of delivery and increased compliance,
due to the absence of needles, as well as ease of distribution. Since the film is small
and likely stable at room temperature it could even be mailed in the post. These benefits
could prove critical in the unfortunate event of an influenza pandemic, when rapid public
access worldwide to influenza vaccines is demanded.
The CEO of BiondVax, Dr Ron Babecoff comments, “I am very proud of the BiondVax team.
The universality and immunogenicity of our universal influenza vaccine, M-001, has been
demonstrated in animal models and in the clinic. Now our success in passing the QP GMP
audit demonstrates the professional nature of our facility, M-001 production process and
team. I believe today’s announcements will prompt discussions with pharmaceutical
companies worldwide to advance clinical development of our universal flu vaccine”.
About BiondVax Pharmaceuticals Ltd.
BiondVax is a publicly traded (TASE: BNDX), advanced clinical stage biotech company
dedicated to improving protection against influenza. The Company’s lead product is a
universal influenza (flu) vaccine called M-001 designed to protect against all flu
strains, seasonal and pandemic, as it triggers our immune defenses to recognize common
parts of the virus. Flu is the most common infectious disease, caused by countless flu
strains, as the virus is continuously mutating to evade our immune defenses.
For further information, please contact: Dana Harel Gelbert- Kahana Tel: +972-3-607-4717 Mob: +972-54-4227715 firstname.lastname@example.org
SOURCE Biondvax Pharmaceuticals Ltd