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”.

BiondVax Passes European QP GMP Audit - The Green Light to Advance Clinical Development of its Universal Flu Vaccine in the EU

BiondVax is declared “a good manufacturing practice (GMP) Company” after passing a European audit; the green light to advance clinical development of its universal flu vaccine, M-001 in the EUBiondVax passes 2 day European qualified person (QP) GMP audit, a key milestone and pre-requisite to conducting advanced clinical trials in Europe.Nes Ziona, Israel – October 18, 2012 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced that the Company underwent a 2 day QP GMP audit and has passed successfully. The QP GMP audit took place over two days 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. BiondVax’s successful passing of this audit gives the Company the go-ahead to manufacture its universal influenza vaccine, M-001, for clinical trials in the EU.The COO of BiondVax, Dr Shimon Hassin comments, “European QP audits are known for their rigor and high level specifications. The successful outcome of BiondVax’s QP GMP audit validates the professional nature of our facility, M-001 production process and team. We are ready to move forward with Phase 2 clinical trials of our universal influenza vaccine, M-001, in Europe.”Dr Ron Babecoff, BiondVax’s CEO, adds, “I am very proud of the BiondVax team, which has transitioned from academic R&D into pharmaceutical professionals. I believe this major achievement will prompt discussions with pharmaceutical companies worldwide to advance clinical development of our universal flu vaccine.”

BiondVax's Universal Flu Vaccine Improves Existing Flu Vaccines in Elderly. In a Second Phase II Trial, the Vaccine Proves Safe and Activates Immunity to Flu

BiondVax's Multimeric-001 Universal Influenza Vaccine successfully meets primary and secondary endpoints, demonstrating excellent safety and immunogenicity in 120 elderly (65+) participantsNES ZIONA, Israel, February 16, 2012, BiondVax Pharmaceuticals (TASE: BNDX) today announced positive results from its second Phase II clinical trial (BVX-005) of the Universal Influenza Vaccine (Multimeric-001) developed by Biondvax for improving  existing flu vaccines in elderly. The vaccine was found to be safe and well tolerated, and induced robust cellular and humoral immune responses in elderly patients (65+), successfully meeting the primary safety and secondary immunogenicity endpoints. In addition, when given as a primer before boosting with a commercially available seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), Multimeric-001 vaccine enhanced the performance of the TIV by increasing immunity to influenza strains contained in the TIV ("prime-boost" regimen). The Multimeric-001 vaccine improved immunity to influenza in the elderly without the need for any adjuvant. The effectiveness of priming with Multimeric-001 was determined by means of hemagglutination inhibition (HAI) assays. HAI-based immune measures are utilized by US and European regulatory authorities to approve and license existing influenza vaccines.Dr. Ron Babecoff, BiondVax's CEO, said, "We are delighted with these Phase II results. We have confirmed, in what is to our knowledge, the first Phase II study of a universal flu vaccine in elderly, that the Multimeric-001 vaccine is not only safe and immunogenic on its own but also enhances the performance of traditional strain-dependent flu vaccines in the elderly when given in a prime-boost regimen."Babecoff added, "We are excited to report that this prime-boost indication for our universal flu vaccine increased immunity to TIV flu strains by more than 10 % - that could translate into over 35 million extra elderly people that potentially avoid the slippery slope of flu illness leading to flu complications, hospitalization and death in this age group."The elderly are a growing population at high risk for influenza and currently under protected. For example in the US, elderly adults constitute 15% of the population but account for 65% of hospitalizations and 90% of deaths attributable to influenza and its complications. This reflects weakening immune systems and the limited immunity provided to the elderly by TIVs. Indeed, of the approximately 350 million elderly worldwide vaccinated with a seasonal TIV each year (about 70% of the total seasonal flu vaccine market), up to 210 million do not respond sufficiently and are not protected against the strains contained in the TIV. Innovative approaches are urgently required to improve protection against influenza among the elderly and hence, to reduce influenza-related morbidity and mortality and associated high economic burden.This Phase II trial was a randomized, double-blind, placebo-controlled study in 120 elderly (65+) volunteers conducted at two clinical research centers in Israel - the Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center. In light of the successful conclusion of this second Phase II clinical trial in the elderly in Israel, BiondVax is preparing to conduct a third Phase II trial in the elderly in Europe. This trial is expected to commence in the third quarter of 2012 and to be concluded in the first quarter of 2013.Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientific Officer, notes that, "the results of this second Phase II clinical trial are most gratifying. We have now shown, in four clinical trials involving 440 participants, that our Multimeric-001 vaccine is safe and effectively activates the immune system, both on its own as well as in conjunction with commercial flu vaccines. Our most recent trial affirms that Multimeric-001, originally conceived as a standalone universal flu vaccine, has a novel and significant new indication - a capacity to improve immunity to flu in the elderly when given in conjunction with TIV, irrespective of the flu strains contained in the TIV. We believe this new indication will facilitate the development and licensing of Multimeric-001"Dr. Ben-Yedidia will report the results of this second Phase II clinical trial in April 2012 at the 2^nd Annual Vaccines Congress inLondon, UK and at the World Vaccine Congress in Washington DC, USA, in a presentation entitled "Multimeric-001: Improving flu vaccines for elderly - new insights from a Phase II clinical trial".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.