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- FLUAD influenza vaccine induces higher level of immune response and exhibits protection against a broader range of strains in vulnerable adults when compared to conventional non-adjuvanted vaccine
- Data support FLUAD vaccine as well-tolerated in vulnerable populations at risk of post-influenza complications
Basel, October 19, 2006 - Novartis announced today data demonstrating the protective benefits conferred by MF59-adjuvanted influenza vaccine (FLUAD) in adults with chronic diseases, at higher risk of post-influenza complications. Specifically, the findings illustrated that FLUAD, when compared to the conventional non-adjuvanted vaccine (Agrippal®), induced a higher level of immune response and superior protection against a broader range of influenza strains in vulnerable populations. FLUAD was also well tolerated. The data were presented at the Second International Conference on Influenza Vaccines for the World (IVW 2006) in Vienna, Austria.
Influenza can cause associated complications, including morbidity and mortality, in individuals with chronic diseases such as cancer, respiratory and cardiovascular disease. While conventional non-adjuvanted influenza vaccines provide protection in 70 – 90 percent of young adults, it can be as low as 17 – 53 percent in the elderly, due to their waning immune system. The addition of the MF59-adjuvant to a conventional vaccine has been shown to augment the antibody response to the vaccination and increase protection of elderly subjects against influenza strains not included in the vaccines (heterovariants). In this study, MF59 was administered to adults with chronic diseases and was shown to be well tolerated, and to offer a greater immune response and broader protection against influenza than a conventional vaccine.
“These data support the use of FLUAD among those at high risk for complications associated with influenza, in addition to the elderly population,” said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostic Division. “We are pleased that they also further illustrate Novartis’ commitment to leadership and innovation in the research and development of influenza vaccines, both adjuvanted and traditional.”
About the study
The randomized, double-blind clinical trial included 238 adults aged between 18 and 60 with chronic diseases, including cancer, diabetes mellitus, cardiac and respiratory disease. Subjects received either FLUAD® or Agrippal® 2005-2006 seasonal vaccine. FLUAD was demonstrated as a well-tolerated vaccine which induces a higher level of immunogenicity than a conventional non-adjuvanted subunit vaccine in adults with chronic diseases. FLUAD offers broader protection against influenza in this population at higher risk of complications even when there is no close genetic homology between the vaccine strains and the circulating strains. Adverse events most frequently reported in the FLUAD group included erythema and pain at the vaccination site. Incidences of systemic reactions including chills, headache and malaise were similar in each vaccination group.
FLUAD is currently licensed for use in the elderly (65 years and above) by 12 European Health Authorities through a Mutual Recognition Procedure and is also registered in other, non-European countries. To date, more than 25 million doses of FLUAD have been distributed and new post-marketing surveillance data presented also this week at the IVW conference, indicate that FLUAD is a well-tolerated and potent vaccine that is particularly effective for protecting vulnerable populations, such as the elderly, against influenza.
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.
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 and 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 and 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.
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Media contacts
Eric Althoff
Novartis Vaccines and Diagnostics
+1 510 923 6500 (direct)
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eric.althoff@novartis.com
John Gilardi
Novartis Global Media Relations
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+41 79 596 1408 (mobile)
john.gilardi@novartis.com
Attachments:
- Novartis Vaccines IVW 2006 Poster Presentations At-A-Glance

- Cell Culture-Derived Influenza Vaccine ("Flu Cell Culture") Technology factsheet

- Novartis Vaccines factsheet

Media materials
For images and video related to Novartis' flu cell culture vaccine development, please visit www.thenewsmarket.com/novartisvaccines. Journalists may register and download print-quality images and broadcast-standard video from this site at no charge.
The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on Novartis' website for historical purposes only. Novartis assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.
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