Novartis announces positive clinical trials for novel H7N9 vaccine results

85% of patients immunologically protected after receiving the second dose of experimental cell culture vaccine when combined with proven adjuvant MF59 ®The vaccine currently in production on a large scale, highlighting the rapid reaction of the FDA approved cell culture technology novel capacity135 laboratory confirmed cases and 45 deaths due to the virus of the H7N9 since the emergence in March, according to the world Organization of health [1]Basel, Switzerland, 14 November 2013 -Novartis announced today preliminary results of a Phase 1 clinical study with its vaccine exclusive cell culture for virus of avian influenza H7N9 involving 400 healthy volunteers (aged 18-64). The data show that 85% of subjects with a protective immune response after two doses of vaccine with adjuvant 15 ug MF59. Only 6% of subjects have a protective when response received two doses of adjuvanted vaccine UN 15ug. The complete set of test data will be submitted to a journal for publication in the near future.The vaccine was produced using cell culture on a large scale manufacturing technology, an alternative technology which can significantly speed up the production of vaccines against the traditional egg-based methods.[2] The cell culture technology uses an eggs line instead of the chicken of mammalian cells well characterized to grow virus strains.[3]"This rapid reaction underlines our position as leader in pandemic preparedness," said Andrin Oswald, Division Head, Novartis Vaccines. "Thanks to our investments in innovative production and adjuvant technologies, we are now able to offer a protection solution for a potentially deadly pandemic virus within a few months after the appearance of the virus H7N9."Reports of infection H7N9 first appeared in China in March 2013. Novartis, along with its partners at the Craig Venter Institute, synthesized the virus strain several days after that, it was shared with global researchers by the Chinese Centers for Disease Control. Novartis then produces clinical batches of first instance, has started clinical trials in August and launched a production on a large scale in its facilities in Holly Springs (NC), United States, and Marburg (Germany) in October.This project was funded in part with federal funds from the Office of the Assistant Secretary for preparedness and response, Biomedical Advanced Research and Development Authority, under contract no. HHSO1002012000141DisclaimerThis press release contains forward-looking statements that can be identified by words such as "will be investigative, acting" or similar expressions, or by express or implied discussions regarding potential effectiveness for Novartis H7N9 avian flu vaccine, or regarding potential future revenues from Novartis H7N9 vaccine against avian influenza. You should not place undue reliance on these statements. These forward-looking statements are based on current beliefs and expectations of management regarding future events and are subject to known and unknown risks and uncertainties. If one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may differ materially from those contained in the forward-looking statements. There may be no guarantee that Novartis H7N9 avian influenza vaccine will receive regulatory approval or be marketed successfully in the future. In particular, the expectations of management regarding Novartis H7N9 avian influenza vaccine could be affected by, among other things, the uncertainties inherent in research and development, unexpected clinical trial results, including additional analysis of existing clinical data; unexpected regulatory actions or delays or Government regulation generally; the company's ability to obtain or maintain exclusive intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including the ongoing price pressures; problems of unexpected manufacturing and other risks and factors current al Novartis AG 20-F Form filed with the Securities and Exchange Commission. Novartis provides the information contained in this press release as of this date, and undertakes no obligation to update the forward-looking statements contained in this press release as a result of new information, future events or otherwise.Subject of NovartisNovartis provides innovative health solutions that respond to the changing of patients and companies needs. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, of eye care, savings of generic pharmaceuticals, preventive vaccines and diagnostic tools, products of over-the-counter health and animals. Novartis is the only multinational one with leading positions in these areas. In 2012, the Group had sales net of $ 56.7 billion, while R & D in all of the Group amounted to approximately 9.3 billion USD (EUR 9.1 billion excluding depreciation and amortization costs). Novartis group companies employ approximately 133,000 associates equivalent full-time and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.Novartis is on Twitter. Sign up to follow the @Novartis to http://twitter.com/novartis.References[1] www.who.int/ influenza/human_animal_interface/influenza_h7n9/en/index.html[2] U.S. Department of Health and Human Services. "HHS Awards contracts totaling more than 1 billion $ in the flu cell. '' 2006 Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html.[3] Gravenstein, Arvydas et al. Culture technique of novel mammalian cells for consistent production of a trivalent subunit vaccine well-tolerated and immunogenic. Vaccine. Flight 27. Number 43. 9 October 2009: 6022-6029. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. 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