| | | Geschrieben am 18-07-2006 Novartis to Build Latest-Technology Influenza Vaccines Manufacturing Site in North Carolina
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 Basel, Switzerland (ots/PRNewswire) -
 
 
 - Novartis Vaccines on track to be the first to manufacture new cell
 culture-derived influenza vaccines in the United States
 - New site to support pandemic preparedness
 - First submission of a cell culture-derived influenza vaccine in the
 European Union completed
 
 
 Novartis announced today plans to build the first cell
 culture-derived influenza vaccines manufacturing plant in the United
 States at a site in Holly Springs, North Carolina, with construction
 expected to begin in 2007.
 
 Novartis also announced today the first European Union submission
 of a cell culture-derived influenza vaccine, also commonly referred
 to as "flu cell culture influenza vaccines." The submission to the
 Committee for Medicinal Products for Human Use (CHMP) was made in
 June after the successful completion of Phase III clinical studies.
 Novartis is also making additional investments in its Marburg,
 Germany, site to expand capacity for flu cell culture vaccines
 production in Europe.
 
 Novartis is seeking to become the first to commercially produce
 and market flu cell culture vaccines for European markets. US
 clinical studies, which began in 2005, are ongoing. The vaccines for
 the EU and US clinical trials have been produced at the Novartis site
 in Marburg, where the product was developed.
 
 "We are taking the lead in moving flu cell culture vaccine
 manufacturing closer to a commercial reality now that the site for a
 US manufacturing plant has been chosen and the first EU submission
 for a flu cell culture vaccine have been completed," said Dr. Daniel
 Vasella, Chairman and CEO of Novartis. "Novartis is pioneering this
 innovative vaccine technology to bring reliability and flexibility of
 the manufacturing process to a next level and be able to meet the
 growing need for seasonal influenza vaccines and to quickly respond
 to a potential pandemic influenza threat once the factory has been
 completed."
 
 A total investment of approximately USD 600 million, which
 includes a recent USD 220 million award from the US Department of
 Health and Human Services, is planned to complete the Holly Springs
 site.
 
 Once completed and approved for commercial production, the planned
 Holly Springs site is expected to annually produce up to 50 million
 doses of seasonal trivalent flu vaccines, which will be for use in
 the US. In the event of an influenza pandemic, the site is planned to
 have a capacity of up to 150 million monovalent doses annually within
 six months of a pandemic declaration.
 
 New flu cell culture vaccine manufacturing technology promises
 many advantages over traditional egg-based production, including
 greater reliability and a reduction in production lead-time. These
 advantages could be pivotal in the event of an influenza pandemic. As
 flu cell culture vaccines move toward commercialization, egg-based
 influenza vaccine production is expected to continue playing a
 critical role in reducing the impact of influenza outbreaks and
 prepare for a potential influenza pandemic.
 
 About the Novartis Vaccines influenza vaccines pipeline
 
 Cell culture-derived influenza vaccines use modern biotechnology
 cell cultures rather than chicken eggs for primary production.
 Current egg-based influenza vaccines production requires several
 months of logistics for ordering and receiving eggs. This lead time
 can hinder the response to unanticipated demands such as the
 discovery of pandemic strains, production failures and seasonal
 influenza virus strain changes. In contrast, flu cell culture
 production enables flexible, faster start-up of vaccine
 manufacturing, and does not depend upon the availability of eggs,
 providing a particularly important advantage in the event of an
 influenza pandemic.
 
 About influenza
 
 Influenza is a contagious, potentially serious respiratory illness
 caused by influenza viruses that attack the upper respiratory tract.
 It can cause mild to severe illness, and at times can lead to death.
 Influenza viruses easily spread from person to person in respiratory
 droplets created by coughing and sneezing. Although difficult to
 assess, annual influenza epidemics are thought to result in between
 three and five million cases of severe illness and between 250,000
 and 500,000 deaths annually around the world.
 
 About pandemic influenza
 
 Pandemic influenza occurs when a new influenza virus emerges that
 causes serious illness and is easily transmitted among humans. In
 this situation, the virus can result in a worldwide outbreak of
 disease, or pandemic. Pandemic influenza occurred three times in the
 last century. Avian influenza, or "bird flu," does not normally
 infect humans, but recent outbreaks of H5N1 avian influenza in Asia
 and the Middle East have resulted in more than 200 human cases, with
 a mortality rate of more than 50%. Millions of birds have been
 destroyed in an effort to contain the virus, which is now considered
 endemic in parts of Asia.
 
 Disclaimer
 
 This release contains certain forward-looking statements, relating
 to the Novartis Group's business, which can be identified by the use
 of forward-looking terminology such as "planned", "promises",
 "expected", "seeks", or similar expressions, or by express or implied
 discussions regarding potential marketing approvals or future sales
 of candidate vaccines. Such statements reflect current views with
 respect to future events and are subject to certain risks,
 uncertainties and assumptions. There can be no guarantee that vaccine
 candidates will be approved for any indications in any market or that
 they will reach any particular sales levels or that final approvals
 from the state of North Caroline and the city of Holly Springs will
 be obtained as expected. In particular, management's expectations
 regarding commercialization of cell culture-derived influenza
 vaccines and particular vaccine candidates could be affected by,
 among other things, additional analysis of clinical data; new
 clinical data; unexpected clinical trial results; unexpected
 regulatory actions or delays or government regulation generally; the
 ability of Novartis to obtain or maintain patent or other proprietary
 intellectual property protection; competition in general; increased
 government, industry, and general public pricing pressures; and other
 risks and factors referred to in Novartis AG's current Form 20-F on
 file with the U.S. Securities and Exchange Commission. Should one or
 more of these risks or uncertainties materialize, or should
 underlying assumptions prove incorrect, actual results may vary
 materially from those anticipated, believed, estimated or expected.
 Novartis is providing the information in this press release as of
 this date and does not undertake any obligation to update any
 forward-looking statements contained in this press release as a
 result of new information, future events or otherwise.
 
 About Novartis
 
 Novartis Vaccines & Diagnostics is a new division of Novartis
 focused on the development of preventive treatments and tools and was
 formed following the recent acquisition of Chiron Corporation. The
 division has two businesses: Novartis Vaccines and Chiron. Novartis
 Vaccines is the world's fifth-largest vaccines manufacturer and
 second-largest supplier of flu vaccines in the US. Novartis Vaccines
 & Diagnostics' products also include meningococcal, pediatric and
 travel vaccines. Chiron, the blood testing and molecular diagnostics
 business, is dedicated to preventing the spread of infectious
 diseases through the development of novel blood-screening tools that
 protect the world's blood supply.
 
 Novartis AG (NYSE: NVS) is a world leader in offering medicines to
 protect health, treat disease and improve well-being. Our goal is to
 discover, develop and successfully market innovative products to
 treat patients, ease suffering and enhance the quality of life.
 Novartis is the only company with leadership positions in both
 patented and generic pharmaceuticals. We are strengthening our
 medicine-based portfolio, which is focused on strategic growth
 platforms in innovation-driven pharmaceuticals, high-quality and
 low-cost generics, human vaccines and leading self-medication OTC
 brands. In 2005, the Group's businesses achieved net sales of USD
 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8
 billion was invested in R&D. Headquartered in Basel, Switzerland,
 Novartis Group companies employ approximately 97,000 people and
 operate in over 140 countries around the world. For more information,
 please visit http://www.novartis.com.
 
 
 Media contacts
 Eric Althoff                              John Gilardi
 Novartis Vaccines & Diagnostics           Novartis Global Media Relations
 Global Communications                     +41-61-324-3018 (direct)
 +1-510-923-6500                           +41-79-596-1408 (mobile)
 +1-510-387-7604(US Mobile)                john.gilardi@novartis.com
 +41-79-593 4202 (CH mobile)
 eric.althoff@novartis.com
 
 
 Media materials
 
 For images and video related to Novartis' flu cell culture vaccine
 development, please visit
 http://www.thenewsmarket.com/novartisvaccines. Journalists may
 register and download print-quality images and broadcast-standard
 video from this site at no charge.
 
 Web site: http://www.novartis.com
 http://www.thenewsmarket.com/novartisvaccines
 
 ots Originaltext: Novartis AG
 Im Internet recherchierbar: http://www.presseportal.de
 
 Contact:
 Eric Althoff of Novartis Vaccines & Diagnostics, Global
 Communications, +1-510-923-6500, +1-510-387-7604 US Mobile,
 +41-79-593 4202 CH mobile, eric.althoff@novartis.com; or John Gilardi
 of Novartis Global Media Relations, +41-61-324-3018 direct,
 +41-79-596-1408 mobile, john.gilardi@novartis.com
 
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