Ness Ziona, Israel
Ness Ziona, Israel

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The present invention relates to pharmaceutical suspensions comprising multimeric- multiepitope influenza polypeptides, to processes for their production and to their use as immunizing subjects against influenza. In particular, the invention relates to stable aqueous microparticulate suspensions comprising a multimeric multiepitope polypeptide.


Dublin, April 18, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Seasonal Influenza Vaccine Market Size, Country Outlook, Vaccination Analysis, Pipeline Insights, Clinical Trials Statement, Deals Type, Regulatory, Price Trends, Competitive Strategies and Forecast, 2016 to 2022" drug pipelines to their offering. Market growth can be attributed to factors such as increased disease awareness, expanded recommendations by governmental and advisory bodies to be vaccinated against seasonal influenza, introduction of quadrivalent influenza vaccines, increase in the size of the elderly population in most countries. The barriers limiting the growth of the influenza market include limited patient awareness regarding the threat of influenza and the importance of influenza vaccinations, high investment and strict regulations act as barriers for new entrants. Further, prudent analysis has been done on the competitor's part, where three major players grab major share of the seasonal influenza vaccine market by revenue. Sanofi Pasteur, GlaxoSmithKline(GSK), Seqirus, AstraZeneca and Protein Sciences Corporation are the key influencers with their products in the seasonal influenza vaccine market. Other emerging players such as Novavax, Daiichi-Sankyo, Mitsubishi Tanabe Pharma, BiondVax Pharmaceuticals Ltd, and VaxInnate are making novel technology based influenza vaccine which is likely to affect the market share during the forecast period. The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projection using a suitable set of assumptions and methodologies. It provides essential insights into seasonal influenza vaccine sales forecasts for the top seven countries, comprising the US, the UK, France, Italy, Spain, Germany and Japan until 2022. It also covers vaccination patterns and geographic distribution and offers a clear view of the regulatory landscape. Additionally, the report includes assessment of clinical trials, pipeline and promising vaccines in seasonal influenza vaccine market. Key trends in terms of M&A, collaborations and licensing agreements are analyzed with details. The report concludes with the profiles of major players in the seasonal influenza vaccine market such as Sanofi Pasteur, GSK, Sequirus, AstraZenecca and Protein Sciences Corporation. The major market players are evaluated on various parameters such as company overview, product outlook, and sales analysis of seasonal influenza vaccine market from 2011 to 2022. The report also entails major drivers and barriers of seasonal influenza vaccine market. Seven Major Markets(7MM) covered in the report are as follows: 1. United States 2. United Kingdom 3. France 4. Italy 5. Spain 6. Germany 7. Japan Major and Promising Vaccines covered in the report are as follows: 1. Fluzone High-Dose 2. Fluzone Quadrivalent 3. Intradermal (ID) Trivalent 4. Vaxigrip 5. Fluarix Quadrivalent 6. Flulaval Quadrivalent 7. Fluenz Tetra 8. FluMist Quadrivalent 9. Flublok 10. VN-100 11. M-001 12. VAX-2012Q 13. TAK-850 14. Flucelvax Quadrivalent 15. Afluria Quadrivalent 16. Agrippal 17. Fluad 18. Fluvirin 19. Fluvax Seasonal Influenza Vaccine Report is segmented into 10 points: 1: Introduction with Executive Summary 2: Forecasts data for the seasonal influenza vaccine market in the top seven countries. This point is divided into 4 segments. - Overall seasonal influenza vaccine market data from 2010 to 2022 - Overall number of persons vaccinated with seasonal influenza vaccine data from 2010 to 2022 - Seasonal influenza vaccine market share in the top seven countries data from 2010 to 2022 - Persons being vaccinated with influenza vaccine share in the top seven countries data from 2010 to 2022 3: Key market drivers and barriers in the seasonal influenza vaccine market 4: Detailed recent and forecasts for the seasonal influenza vaccine markets in the US, the UK, France, Italy, Spain, Germany and Japan, comprising of market size, total number of persons vaccinated, number of children vaccinated, number of 60+ years of age persons vaccinated, number of pregnant women vaccinated, number of chronic medical condition persons vaccinated, number of healthcare workers vaccinated and vaccination coverage 5: Detailed information on seasonal influenza vaccine production & distribution in United States. The information includes vaccine choices remain available for patients, providers, prices of a dose of vaccine, production, supply, and allocation by the major seasonal influenza vaccine manufacturers, seasonal influenza vaccine distribution & demand, seasonal influenza vaccine effectiveness, managing influenza with diagnostic resources, distribution method of seasonal influenza vaccination 6: Information about regulatory landscape including the approval process and an overview of the regulatory authorities in the United States, EU and Japan 7: Key M&A deals that took place in the seasonal influenza vaccine market between 2003 and 2015 and lists the major collaborations, licensing, exclusive and distribution agreements deals 8: Detailed pipeline influenza vaccines in various companies' pipelines with clinical development and early stage development vaccines 9: Detailed information of the recruiting clinical trials statement by phase, trial status, study sponsor name and study phase 10: Information on the key players in the market with business overview, product outlook and sales analysis of the seasonal influenza vaccine For more information about this drug pipelines report visit http://www.researchandmarkets.com/research/jc66pd/seasonal


Flu viruses frequently and unpredictably mutate. Since it is impossible to predict future mutations, current flu vaccines may target strains that are not represented in the current wave of influenza. Mainly due to vaccine-virus mismatch, current flu vaccine effectiveness is on average only about 40%[1] in the general population, and in elderly people as low as 9%.[2] In addition, current vaccines take about four to six months to produce, and a new one must be produced each year. So when a mismatch is identified at the beginning of the flu season, there is insufficient time to make a new vaccine for that specific season. The World Health Organization (WHO) reports up to 500,000 annual seasonal flu related deaths, mostly affecting people above 65 years old.[3] Seasonal flu is the 8th leading cause of death in the USA[4], and it causes high social and economic burdens to patients, their families, and health care providers. BiondVax's M-001 vaccine candidate, consisting of nine widely conserved flu epitopes, is designed to protect against current and future, seasonal and pandemic flu strains. Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines. M-001 has also shown potential to improve upon current seasonal flu vaccines, and potential to serve as an immediate effective response to new flu pandemic strains.[5] The vaccine candidate has been tested in a Phase IIb clinical trial in collaboration with UNISEC,[6] which is funded by the EU under the 7th Framework Programme for Research and Technological Development. EIB support for the development of BiondVax's Universal Flu Vaccine Candidate should be seen in the context of the Horizon 2020, the EU's Research Programme, in particular the EU Finance for Innovators finance facility "InnovFin Infectious Diseases", which offers bespoke products for financing high-risk projects in the field of infectious diseases. Carlos Moedas, European Commissioner for Research, Science and Innovation said, "A healthier population is a major priority for the EU, and preventing and treating the flu is becoming more and more important with the ageing of the European population. As the virus rapidly changes, we need to develop new ways to combat the disease. This €20 million loan agreement will help develop a more universal vaccine, effective in preventing a range of different types of flu." Mr. Othmar Karas, Member of the European Parliament and EPP-Shadow Rapporteur for the extension of the European Fund for Strategic Investments in the Parliament's Committee on Economic and Monetary Affairs, commented, "Joint investments in the future build strong bridges between nations. It is a strength of Europe's innovation system to cooperate with the best innovators in our neighbourhood. We are glad to see today's announcement as an important initiative for fostering innovation between the European Union and our Mediterranean neighbours." "Supporting innovation is a key priority for the European Union's Bank", said EIB Vice-President Mr. Ambroise Fayolle. "This new financing shows our strong willingness to create optimal conditions for this clinical research and bring it to a successful conclusion. The EIB is proud to be supporting BiondVax with regard to its high expertise and pioneering research on such a universal flu vaccine. We hope that this innovative financing will contribute to improve the prevention of disease." The technology behind BiondVax's universal flu vaccine candidate was conceptualized in the lab of Professor Ruth Arnon at the Weizmann Institute of Science. Weizmann Institute Vice-President for technology transfer Prof. Mordechai Sheves noted, "Yeda, the tech transfer arm of the Weizmann Institute of Science, was delighted to learn that the European Union has found merit in BiondVax, a company based on the pioneering work of Prof. Ruth Arnon. The generous investment by the European Union paves the way to tackling one of today's most lethal infectious diseases, and is yet another example of the outstanding basic research that typifies the Weizmann Institute of Science." Dr. Ron Babecoff, CEO of BiondVax, commented, "We now have the resources to launch Phase 3 trials and set-up a mid-sized commercial manufacturing plant. The EIB's funding is a monumental step forward for BiondVax towards bringing M-001 to the market. We are proud and honored that the EIB and the European Commission chose to collaborate with BiondVax in the development of our universal flu vaccine. Together with the support of Israel's Ministry of Economy, we are closer than ever to accomplishing our mission of marketing the first universal flu vaccine for the benefit of people worldwide." "It has been a pleasure working with the EIB team towards this collaboration, and I wish to thank them for their support and interest. We also greatly appreciate the assistance of Mr. Holm Keller and his team at kENUP for facilitating this financing," continued Babecoff. The finance contract between BiondVax and the EIB has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe. kENUP Chairman Mr. Holm Keller noted that, "The State of Israel's substantive and smart investments in fundamental research are an important catalyst for establishing globally leading industries in Europe. We are proud to be a liaison between the relevant European institutions and Israel's leading research institutions." Innovation and skills are key ingredients for ensuring sustainable growth and creating high-value jobs. They play an important part in driving long-term competitiveness. For this reason, innovation and skills are a top priority for the EIB Group with a total financing of €18.7 billion in 2016. The EIB-BiondVax non-dilutive financing agreement will be structured as a zero-percent fixed interest loan, available for up to 36 months with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement, and are dependent on achievement of certain specified milestones, with the ultimate milestone including authorization to launch a Phase 3 trial. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time. Under Horizon 2020, the EU Research and Innovation Framework Programme for 2014-20, the European Commission and the European Investment Bank Group (EIB and EIF) launched a new generation of financial instruments and advisory services in 2014 to help innovative firms access finance more easily. Up until 2020, "InnovFin - EU Finance for Innovators" will offer a range of bespoke products which will make available more than €24 billion worth of finance in support of research and innovation (R&I) products undertaken by small, medium-sized and large companies and promoters of research infrastructure. Backed by funds set aside under Horizon 2020 and by the EIB Group, InnovFin financial products are used to support R&I activities, which by their nature are riskier and harder to assess than traditional investments, and therefore often face difficulties in accessing finance. Firms and other entities located in EU Member States and Horizon 2020 Associated Countries are eligible as final beneficiaries These debt instruments are complemented by a series of equity instruments managed by the EIF. The facility for financing research into infectious diseases enables a wide range of financial products to be offered, ranging from standard debt instruments to risk sharing instruments, amounting to between €7.5 million and €75 million, for researchers working to develop innovative vaccines, medicines, or medical and diagnostic equipment or new research infrastructure specialising in infectious diseases. The final beneficiaries are project promoters who have successfully negotiated the preclinical stage. The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. Further details are available at: http://www.eib.org BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com. kENUP promotes research based innovation for the public and societal benefit. It facilitates the development of projects to pursue market-leading positions for European innovation businesses. kENUP is registered in the EU as a lawful purpose foundation. This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. risks and uncertainties include, but are not limited to, the receipt and timing of approved grant funds, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, our ability to procure the funds and permits and other governmental authorization for a commercial size manufacturing plant, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange. For further information, please contact: Anne-Cécile Auguin +352-43-79-83330 / mobile: +352-621-36-19-48 a.auguin@eib.org Press Desk: +352-4379-21000 - press@eib.org 5. Back to the Future: Study Published in Vaccine Journal Indicates BiondVax's Universal Flu Vaccine Candidate May Cover Strains Which Don't Yet Exist: http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/


Pharmaceutical suspensions of multimeric-multiepitope influenza polypeptides, processes for their production and their use as immunizing subjects against influenza. In particular, stable aqueous microparticulate suspensions of a multimeric multiepitope polypeptide are disclosed.


News Article | June 28, 2017
Site: www.prnewswire.com

Ron Babecoff, BiondVax CEO, commented, "The first half of 2017 was exciting and important for BiondVax. Three major events occurred: (1) We welcomed a major strategic investor, Marius Nacht and his aMoon Fund, who currently hold approximately 20% of our company; (2) Israel's Ministry of Economy approved a grant covering 20% of the construction costs of a commercial scale manufacturing facility; and also significantly advancing our goals, (3) the European Investment Bank (EIB) signed a €20 million non-dilutive funding agreement to support commercial production and Phase 3 trials. I am thrilled that we now have the resources to launch our Phase 3 program towards commercialization." BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com . This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the receipt and timing of approved grant funds, our ability to procure the funds and permits and other governmental authorization for a commercial size manufacturing plant, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange. 1. The research has received funding from the European Union Seventh Framework Program (FP7/2007-2013) under grant agreement n°602012. For further information, please contact: Joshua Phillipson Business Development Manager +972-8-930-2529 ext.5105 j.phillipson@biondvax.com


News Article | May 30, 2017
Site: www.prnewswire.com

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.63 (NIS/$US) as at March 31, 2017. As of March 31, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 35 million ($9.6 million) as compared to NIS 27 million as of December 31, 2016. The increase is attributable to a private placement of NIS 10.9 million. BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com. This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated  Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biondvax-announces-first-quarter-2017-financial-results-and-update-300465204.html


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.2.3.0-1 | Award Amount: 7.82M | Year: 2013

UNISEC brings together a European consortium of 3 University partners, 5 National Health Institutes and 4 SMEs, all with leading expertise in influenza vaccine research and development, to work on promising recently developed concepts for a universal influenza vaccine. The consortium is exceptionally strong, interdisciplinary and intersectional in nature, and encompasses a unique combination of scientific and technological expertise from lead identification to clinical trial execution. UNISEC will bring a number of vaccine concepts together into a single study in order to identify, develop and clinically test the 3 most promising leads for a universal influenza vaccine, which must (1) demonstrate adequate (universal) protection, and (2) be technically suitable for development to a marketable product. Preclinical and clinical methodologies will be developed allowing a comparative evaluation of the vaccine concepts. Head-to-head comparisons in animal models will also be performed, with the most promising concepts to then be ready for clinical assessment. Independent comparative clinical studies will be executed and carried out by 5 established Clinical Trial Site partners. The expected impact of the UNISEC work programme will be the resolution of current problems of non-uniformity in the development and evaluation of universal influenza vaccines in Europe by a unified approach using an expert and sustainable vaccine expertise network. The UNISEC results will directly contribute to a timely, longer-term, broader, more effective and cost-effective universal influenza vaccine for the prevention of annual and pandemic influenza. The success of UNISEC will be based on the leading experience of its consortium partners; the proven track record of its clinical trial site partners; and a coherent and well-defined management structure and dissemination program, underpinned by the fact that several UNISEC partners were previously part of the successful EU FLUSECURE project.

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