BiondVax and MonoSol Rx to collaborate on developing oral delivery for universal flu vaccine, M-001.
A material transfer agreement has been executed to allow sharing of patented technologies with the goal of formulating M-001 as a film stable at room temperature administered by placing under the tongue.
Nes Ziona, Israel – October 18, 2012 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today 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® technology. M-001 in this form would be administered orally and should be stable at room temperature. 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 CSO of BiondVax, Dr Tamar Ben-Yedidia comments, "The universality and immunogenicity of our universal influenza vaccine, M-001, has been demonstrated in animal models and in the clinic. Now that we are taking M-001 through the advanced stages of clinical development, it is the right time to explore the option of delivery by mouth, as this route is easier for most people".
Dr Ron Babecoff, BiondVax's CEO adds, "We are happy BiondVax is receiving worldwide recognition, which will enable us to move into the next phase of our business development, namely securing agreements with international Pharmaceutical and Biotech Companies".
About BiondVax Pharmaceuticals Ltd
BiondVax is a publicly traded (TASE: BNDX), advanced clinical stage biotech company dedicated to improving protection against influenza, with its lead product a universal influenza (flu) vaccine called M-001. Flu is the most common infectious disease, caused by countless flu strains, as the virus is continuously mutating to evade our immune defenses. Currently, seasonal flu vaccines are re-formulated each year as they only protect against 3-4 strains (those predicted to be in circulation) and pandemic flu vaccines (in stockpiles) are designed to protect against 1 strain that is considered the most likely public health threat. BiondVax's universal flu vaccine is designed to protect against all flu strains, seasonal and pandemic, as it triggers our immune defenses to recognize conserved and common parts of the virus.
Weizmann Science Park, 14 Einstein Street, PO Box 4143, Nes Ziona 74140, Israel
Tel: +972 8 930 2529 ● Fax:+972 8 930 2531 ● www.biondvax.com
At this point in time, BiondVax's M-001 has several unique competitive advantages: it is the universal flu vaccine at the most advanced stage of clinical development (4 clinical trials with 440 people); it has an excellent safety profile; it triggers both arms of our immune defenses, cellular and humoral (antibodies); it is active without the need for an adjuvant; it is easily, quickly and cheaply manufactured in only 6-8 weeks (current vaccines take 6-8 months); as its composition does not change it can be produced year-round and stockpiled; and finally, M-001 has two indications, as a universal flu vaccine and as an enhancer of current seasonal/pandemic flu vaccines. Of note, this second indication provides a possible alternative pathway for clinical development, regulatory approval and commercialization of M-001 and is a new approach to improving pre-pandemic preparedness.
About MonoSol RX
MonoSol Rx located in New Jersey, USA, is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription drug products (Zuplenz® and Suboxone®) and a pipeline of prescription formulations based on PharmFilm® technology.
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Tel: +972 3 607 4717
Mob: +972 54 4227715
BiondVax`s estimates regarding the future development of the vaccine and expected trials with respect to the vaccine are forward looking information based on the information that BiondVax has in its possession today pertaining to the potential of the vaccine`s development. These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including the failure to reach the objectives of the trials and/or schedules and/or to obtain the necessary funding for the continuation of development of the vaccine as well as other factors which are not within BiondVax's control and the materialization of any of the risk factors detailed in Section 5.27 of BiondVax`s shelf prospectus published on January 17, 2012.