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Thursday, 12/03/2015 10:11:53 AM

Thursday, December 03, 2015 10:11:53 AM

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BiondVax to Bring Long-Awaited Universal Flu Vaccine to the Market


LOS ANGELES, Dec. 3, 2015 /PRNewswire/ - With various advancements being made in preventative care, cancer treatment, HIV and AIDS research and aging, it's hard to believe that the flu is still a serious health threat. However, influenza, an acute respiratory tract infection, can still prove life threatening for the elderly and those with weak immune systems. A common misconception is that influenza is merely a bad cold. Yet, while the flu may produce similar symptoms to the common cold like coughing or nasal congestion, the World Health Organization reports that 250,000 to 500,000 individuals die annually due to the flu, with the majority of those deaths caused pulmonary and cardiovascular complications. Every year, 36,000 people die in the United States and more than 200,000 are hospitalized due to the flu, along with an annual economic burden of over $25 billion.

Although flu vaccinations are widely available, they only protect against a very specific strain of flu. Also, due to increasing international travel, as well as over-population associated with poor sanitary conditions for humans and livestock living together in some developing countries, an influenza pandemic is becoming one of the major concerns among health authorities. BiondVax Pharmaceuticals Ltd. (BVXV), an Israeli based clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, is currently attempting to bring to market a long awaited solution to the world of medicine and preventative care.

Rooted in the Work of a Modern Scientific Figure
Located in the Weizmann Science Park in Ness-Ziona, Israel, BiondVax is dedicated to the development of a universal flu vaccine. The company's leadership comprises of some of the most noted figures in the field. Dr. Ron Babecoff, CEO of BiondVax, has 10 years of marketing and business development experience in the pharmaceutical industry, co-founded BiondVax in 2003. With a background in veterinary medicine, Babecoff understands the connection between animals and the flu or the pandemic. Tamar Ben-Yedidia, the company's Chief Scientific Officer, has dedicated her life's work to finding a universal solution to the flu. She also happened to have studied under the company's scientific advisory board head and Weizmann Institute professor, Ruth Arnon. Twenty years of research conducted and led by Ruth Arnon has resulted in BiondVax's universal flu vaccine. Arnon is also well known for her contribution in the development of the drug treatment for multiple sclerosis, Copaxone™.

The greatest challenge in protecting oneself from catching the flu is that the flu is slowly evolving. To date, there are around 40,000 documented, discovered or tested strains of flu. Even when a modern flu vaccine is administered, the individual is still left vulnerable. The elderly and children, due to possibly having a weak immune system, are left most at risk in developing life-threatening complications from the flu. BiondVax's universal vaccine not only protect against the current season's strain of flu, but also protect against any and every type of flu, both seasonal and pandemic.

A Universal Solution to a Global Problem
According to their official website, BiondVax's technology utilizes a unique, proprietary combination of conserved and common epitopes from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect. The Company holds a worldwide exclusive license granted by Yeda Research and Development Ltd., the commercial arm of the Weizmann Institute, Israel, for developing, manufacturing and commercializing this innovative flu vaccine.

Two companies in the US produce the seasonal vaccines currently in use. Although current vaccines were reported to only have a 19% effectiveness rate in 2014, flu vaccines are, annually, a multi-billion dollar industry. "The current vaccine, despite the fact that the market is around $3 billion a year, just doesn't work properly," said Kenny Green of GK Investor Relations, BiondVax's investor relations contact. "If your car works only 10% of the time, you probably wouldn't buy something like that. There's this huge market for something that really doesn't work."

A World Free From a Pandemic Threat
How effective is BiondVax's universal vaccine? This past August, the company announced that a statistical analysis of results from a study which demonstrates that BiondVax's universal flu vaccine (M-001), administered in a 2012 BVX-005 phase II trial, provided participants with increased immunogenicity against future strains that did not exist at the time of the study.

During the BVX-005 phase II trial conducted in 2012, 90 participants were injected with the M-001 universal flu vaccine a few weeks prior to being immunized with the TIV vaccine. The remaining 30 participants received a placebo, followed by the TIV immunization. In 2015, when BiondVax exposed the blood plasma samples from the BVX-005 participants to the flu epidemic H3N2 strain, the company found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine.

Currently, the vaccine is in phase II trials in Europe, with phase 2 trials, ran by the NIAID, beginning in the United States next year. BiondVax's flu vaccine patent was recently approved in Korea, and has also been granted approval in Europe and Japan.

Because Biondvax protects against all flus, annual flu vaccinations will no longer be required. Furthermore, the Biondvax's flu vaccine will provide a much needed relief to fighting a pandemic threat. Instead of having to stockpile 20 million doses for each potential pandemic, a country would only have to stockpile the amount needed for their population. Overall, the flu vaccine market would no longer be a captured market, but an innovative market that provides a much needed, potentially life-saving solution. "There will be a solution that actually works," said Green. "It would be absolutely huge."

For more information about BiondVax, visit www.biondvax.com.
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