Novartis MF59®-adjuvanted vaccine rapidly induces protective antibody
levels against diverse strains of avian flu
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* Study shows the investigational pre-pandemic vaccine AFLUNOV®
provides rapid immune response in individuals primed with
MF59-adjuvanted H5 vaccine up to six years earlier[1]
* Individuals primed with MF59 adjuvant developed immunity seven
days after receiving the AFLUNOV booster
* Study supports notion of pre-pandemic vaccination to ensure
protective antibody levels in population with one additional
immunization in the event of a pandemic
Basel, September 19, 2008 - A new study shows that individuals
immunized six years earlier with an MF59 adjuvanted H5N3 (clade 0)
vaccine mounted a protective immune response seven days after a
single immunization with an H5N1 (clade 1) vaccine containing the
Novartis proprietary adjuvant MF59. The immune response was broadly
cross reactive and covered all H5N1 clades known to date. These data
were presented at the Third European Influenza Conference in
Vilamoura, Portugal.
Responses were seen even against viral strains not included in either
vaccine[1] suggesting proactive priming strategies with an MF59
adjuvanted-H5 vaccine may have the potential to help save lives in an
avian influenza pandemic situation.
"These data highlight the potential for priming the public against an
avian influenza of pandemic proportion with the MF59 adjuvant. The
results indicate that regardless of which avian strain individuals
are originally primed with, they are quickly protected against a
broad range of avian strains following their MF59-adjuvanted booster
vaccine, even strains they were not initially inoculated against,"
said study investigator Iain Stephenson M.R.C.P., Infectious Diseases
Unit, University Hospitals Leicester and Department of Inflammation,
Infection and Immunity, University of Leicester, UK.
"These results potentially provide a rationale to prevent pandemic
influenza by proactively immunizing the public with stockpiled
pre-pandemic vaccines containing MF59," Dr Stephenson added.
According to the trial results, healthy adults primed with an
MF59-adjuvanted H5 vaccine at least 6 years ago, and boosted with the
Novartis pre-pandemic vaccine AFLUNOV (7.5microgram MF59-adjuvanted
A/Vietnam/1194/2004 clade 1 H5N1), showed a protective cross-reacting
antibody response to diverse H5N1 virus variants. Response was seen
within 7 days and results were significantly higher (P< 0.05) at 14
days than those primed with a un-adjuvanted vaccine[1]. In addition,
these study results suggest primed individuals would only need one
dose of an MF59-adjuvanted vaccine in a pandemic situation to elicit
initial protection reducing overall response time, and potentially
the spread of the virus[1].
"These findings show that priming subjects with the Novartis
proprietary adjuvant MF59 included in AFLUNOV can induce long-lasting
immune-memory and further supports a proactive priming strategy as
part of pandemic preparedness efforts" said Dr. Joerg Reinhardt, CEO
of Novartis Vaccines and Diagnostics, a division of Novartis.
"Novartis Vaccines is committed to putting forth the most effective
vaccine possible to help protect the global public against a possible
pandemic situation."
An influenza pandemic occurs when a new influenza strain emerges (one
to which humans have no immunity), mutates and spreads globally as a
virus. Although it is not possible to predict the actual pandemic
influenza strain, global health authorities have identified H5N1
avian influenza as a strain with the greatest pandemic potential in
humans[3]. H5N1 is currently circulating in birds and has caused
serious illness in more than 380 people worldwide with a mortality
rate, among people known to have been infected, of greater than 60
percent[4].
The purpose of pre-pandemic vaccination is to prime the immune system
to better defend against infections from an H5N1 influenza virus and
is intended for use before the World Health Organization (WHO)
declares an influenza pandemic. AFLUNOV is the only pre-pandemic
vaccine in development with an extensively-studied adjuvant, MF59,
that is supported by more than 10 years of clinical safety data and
commercial use.
Study details
In an open-label study, 54 healthy adults (age 23-60 years) received
two doses of AFLUNOV (7.5microgram MF59-adjuvanted
A/Vietnam/1194/2004 clade 1 H5N1) vaccine 21 days apart. Twenty-four
subjects were primed with either MF59-adjuvanted or an un-adjuvanted
H5N3 (A/duck/Singapore/1997 clade 0-like) vaccine at least 6 years
earlier and 30 subjects were unprimed[1]. Some subjects also received
a booster dose, 16 months after primary immunization. Pre and
post-vaccination antibody to antigenically diverse H5 viruses were
measured by hemagglutination-inhibition (HAI), neutralizing antibody
(MN) and single radial hemolysis (SRH).
Among primed subjects, protective cross-reacting antibody titers to
diverse H5N1 virus variants were seen by day 7 after a single vaccine
dose[1]. In subjects primed with an MF59-adjuvanted vaccine responses
were statistically significantly higher (P< 0.05) than those primed
with un-adjuvanted vaccine. By day 7, after one dose of AFLUNOV,
>=80% of MF59-H5 primed recipients achieved sero-protective HAI
titers of >=1:40 to all clade 1, 2.1, 2.2, and 2.3 avian H5 virus
variants tested as well as the original antigen. In MF59-H5N3 primed
subjects, responses were greatest at day 14 with geometric mean
antibody titers of 1:378, 1:1754 and 73mm2 to the clade 1
A/Vietnam/2004 vaccine strain and 1:347, 1:2128 and 72mm2 to a clade
2 A/Turkey/2005 variant by HAI, MN and SRH respectively[1].
Novartis Vaccines commitment to pandemic preparedness
The immune-enhancing Novartis Vaccines proprietary adjuvant MF59 may
enhance the body's immune response to the vaccine's active
constituent (antigen) and offer varying degrees of cross-protection
to better defend against the potentially dangerous disease causing
infections from an H5N1 virus. In the seasonal influenza vaccine
Fluad®, MF59 has been shown to better enhance the antibody response
to vaccination when compared to non-adjuvanted vaccines, to increase
protection in the elderly, and to provide protection even against
influenza strains not included in the vaccine[5], [6]. Fluad has a
history of proven safety and tolerability, with more than 40 million
doses distributed worldwide since 1997[7].
Novartis Vaccines is working closely with government and regulatory
officials worldwide to support pandemic preparedness efforts,
including engaging in government contracts to provide H5N1 vaccines
for stockpiling. The Company has also been involved in discussions to
educate government agencies about the benefits of proactive use of
pre-pandemic vaccination in pandemic preparedness planning efforts.
Novartis Vaccines is supportive of the WHO's leadership role in
global pandemic planning as discussed in the organization's "THE
WORLD HEALTH REPORT 2007: Global Public Health Security in the 21st
Century." The WHO is a key global hub for pandemic preparedness,
ensuring cohesion and coordination among all players involved,
including the industry, governments of both developed or developing
countries and their populations.
The Company also recognizes the importance of pandemic influenza
preparedness planning within the business community in an effort to
protect the global economy. With this commitment, Novartis Vaccines
is working with business leaders to support their continuity planning
for pandemic preparedness.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may", "potential", "potentially",
"suggest", "would", "can", "committed", "possible", "intended", or
similar expressions, or by express or implied discussions regarding
the potential that AFLUNOV® or an MF59 adjuvanted vaccine will be
approved for sale in any market, or regarding potential future
revenues from such products. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current
views of the Company regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual
results with to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that AFLUNOV® or an MF59 adjuvanted vaccine
will be approved for sale in any market. Nor can there be any
guarantee that such products will achieve any particular levels of
revenue in the future. In particular, management's expectations could
be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; the Company's ability
to obtain or maintain patent or other proprietary intellectual
property protection; competition in general; government, industry and
general public pricing pressures; the impact that the foregoing
factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US 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 AG provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2007, the
Group's continuing operations (excluding divestments in 2007)
achieved net sales of USD 38.1 billion and net income of USD 6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 98,000 full-time associates and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1.] Stephenson, I, et al, Rapid immunity to diverse influenza H5N1
by boosting primed subjects with antigenically distinct
MF59-adjuvanted vaccine: pre-pandemic vaccine strategy, Third
European Influenza Conference, 15 September 2008, Vilamoura,
Portugal.
[2.] Ferguson, N. et, al, Strategies for mitigating an influenza
pandemic. Nature. 2006 Jul 27;442(7101):448-52.
[3.] World Health Organization Avian influenza H5N1 infection in
humans, WHO Web site:
http://www.who.int/csr/don/2004_01_22/en/index.html, accessed August
22, 2008
[4.] World Health Organization Cumulative Number of Confirmed Human
Cases of Avian Influenza, WHO Web site:
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2008_06_19/en/index.html,
accessed August 19, 2008
[5.] Puig-Barbera J et al. Effectiveness of MF59-adjuvanted subunit
influenza vaccine in preventing hospitalizations for cardiovascular
disease, cerebrovascular disease and pneumonia in the elderly.
Vaccine 2007; 25 7313-7325.
[6.] Baldo V, Baldovin T, Angiolelli G, Trivello R. MF59-adjuvanted
influenza vaccine (FLUAD): assessment of the immunogenity against
homologous and heterologous strains in elderly subjects. Data
presented at Options VI, June 2007.
[7.] Company data on file.
# # #
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