Focetria® pandemic influenza vaccine receives positive European Unionregulatory agency opinion supporting approval

* Approval of Focetria, an immune enhancing pandemic influenza
  vaccine, would allow for more rapid response in the event of
  influenza pandemic
 
Basel, February  23, 2007  -  Novartis announced  today that  it  has
received a  positive  opinion supporting  European  Union  regulatory
approval of the human  vaccine Focetria® for use  in the event of  an
pandemic influenza outbreak, such as one that could be caused by  the
H5N1 virus.
 
The Committee  for Medicinal  Products for  Human Use  (CHMP),  which
reviews applications for all  27 countries in  the European Union  as
well as  Iceland and  Norway, has  recommended approval  of this  new
vaccine.   The    European   Commission    generally   follows    the
recommendations of the  CHMP and delivers  its final decision  within
two to three months.
 
The EU submission for  Focetria was considered  a "mock-up" since  it
lays the groundwork for a more  rapid approval and availability of  a
specific vaccine once a pandemic has been declared.
 
Focetria would  be manufactured  to  contain the  pandemic  influenza
strain declared at the time of a pandemic along with the  proprietary
adjuvant MF59 developed  by Novartis.  Studies have  shown that  MF59
could boost  the  body's  immune response  to  the  vaccine's  active
constituent and  extend  vaccine  supplies by  allowing  for  smaller
amounts of  viral  antigens to  be  used  in each  dose  compared  to
vaccines without this additive.
 
"The availability  of a  pandemic influenza  vaccine soon  after  the
declaration of a pandemic is  essential to reduce disease burden  and
deaths.   This   positive   recommendation   for   our    proprietary
MF59-adjuvanted  pandemic  vaccine  brings  us  one  step  closer  to
achieving public health  and pandemic preparedness  goals," said  Dr.
Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics, a  division
of Novartis.
 
"We are  committed  to  working with  governments  and  international
organizations to reduce the impact  of an influenza pandemic  through
ongoing  research  and  development  projects  for  pre-pandemic  and
pandemic influenza vaccines," Reinhardt said.
 
Novartis submitted the Focetria mock-up file for EU approval in early
2006. Once the World Health  Organization (WHO) declares a  pandemic,
Novartis will submit a revised application to the European  Medicines
Agency (EMEA)  to  incorporate  the  identified  viral  strain.  This
revised application can be approved  more quickly than a totally  new
application. The filing for the Novartis mock-up vaccine was based on
clinical studies  involving  the  MF59 adjuvant  and  different  H5N1
strains with pandemic potential.
 
Separately,  Novartis   has   submitted   an   MF59-adjuvanted   H5N1
pre-pandemic influenza  vaccine for  EU approval  based on  the  same
technology as Focetria. This vaccine is  intended for use prior to  a
pandemic declaration to  help prime  and boost the  immune system  of
those receiving the vaccine to better defend against infections  from
a H5N1 virus.
 
Novartis commitment to pandemic preparedness
Novartis is working closely with government and regulatory  officials
worldwide to  support  pandemic preparedness  efforts.  Novartis  has
engaged in discussions with  several governments concerning  pandemic
influenza  vaccine  supply  and   has  provided  H5N1  vaccines   for
stockpiling, notably in the US and UK.
 
In January  2007, the  US  Department of  Health and  Human  Services
awarded Novartis a  USD 55  million contract to  further develop  the
adjuvant technology of MF59 in  the US to potentially extend  vaccine
supplies in case of a pandemic outbreak.
 
An adjuvant is a substance added  to a vaccine to enhance the  body's
immune response  to  the  vaccine's active  constituent,  called  the
antigen. Research supporting the use of the MF59 adjuvant includes:
 
  * Clinical trial data presented at the Second International
    Conference on Influenza Vaccines for the World (IVW 2006)
    confirming that the addition of the MF59 adjuvant can augment
    antibody response and increase protection of subjects against
    circulating influenza strains not included in the vaccines
  * Clinical research published in The Lancet in 2001 demonstrating
    that an MF59-adjuvanted vaccine, based on the non-pathogenic H5N3
    virus strain, induced antibodies against H5N1 influenza virus at
    lower antigen levels
  * A study published in the Journal of Infectious Diseases in 2005
    showing that an MF59-adjuvanted vaccine induced broadly
    cross-reactive antibodies capable of neutralizing H5N1 viruses
    isolated from a number of Southeast Asian countries between 1997
    and 2004
  * Clinical trial data, supported by the US National Institutes of
    Health (NIH), of an MF59-adjuvanted vaccine against an H9N2 avian
    influenza virus that were published in 2006 in the online edition
    of Clinical Infectious Diseases; in this study, an
    MF59-adjuvanted vaccine induced antibody levels believed to offer
    protection using one quarter of the dose level used against a
    seasonal flu strain
 
Additionally, Novartis  has  developed a  new  vaccine  manufacturing
process that uses cell cultures rather than chicken eggs for  antigen
production. The new  technology may  reduce production  time to  meet
demands of influenza outbreaks and to combat evolving strains of  the
virus, including avian influenza strains  that are difficult to  grow
in eggs. The cell culture-based vaccine Optaflu® was submitted for EU
regulatory approval in July 2006 and is currently in clinical studies
in the US.
 
About H5N1 avian influenza
Global health authorities have identified H5N1 avian influenza as  an
aggressive viral strain  with pandemic  potential. While  researchers
have not quantified the likelihood of  an outbreak, to date H5N1  has
caused serious illness in Southeast Asia in more than 250 people. The
mortality rate of patients investigated has been over 50 percent.[1]
An influenza pandemic would be  expected to spread quickly  globally;
licensing  and  production  of  sufficient  quantities  of   pandemic
vaccines is therefore an enormous challenge. The WHO recommends early
vaccine development and use to reduce disease severity and  mortality
and stresses the  need to work  collaboratively with researchers  and
manufacturers towards ensuring that as much as possible, vaccines and
antiviral drugs are available at the start of a pandemic[2].
 
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 "supporting approval,"  "would,"
"could", "committed",  "will,"  "can  be," "may  reduce"  or  similar
expressions, or by express or implied discussions regarding potential
marketing approvals or  future sales of  Focetria or other  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  Focetria or other  vaccines will  be
approved for any indications  in any market or  that Focetria or  any
vaccines will  reach  any  particular sales  levels.  In  particular,
management's expectations regarding Focetria and other vaccines could
be affected by, among other things, unexpected regulatory actions  or
delays or government regulation generally; unexpected clinical  trial
results, including additional analysis of existing clinical data  and
new clinical data; competition in general; the ability of Novartis to
obtain or maintain patent or other proprietary intellectual  property
protection;  increased  government,  industry,  and  general   public
pricing pressures; and  other risks  and factors referred  to in  the
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 Vaccines  and  Diagnostics is  a  new division  of  Novartis
focused on  the  development  of  preventive  treatments  and  tools.
Novartis Vaccines  is  the  world's  fifth-largest  manufacturer  and
second-largest  supplier  of  influenza  vaccines  in  the  US.   The
division's 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, cure 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.  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.  Novartis  is  the  only  company  with
leadership positions in these areas. In 2006, the Group's  businesses
achieved net sales  of USD  37.0 billion and  net income  of USD  7.2
billion.  Approximately  USD  5.4   billion  was  invested  in   R&D.
Headquartered in Basel, Switzerland, Novartis Group companies  employ
approximately 101,000 associates  and operate in  over 140  countries
around the world.
 
For more information, please visit http://www.novartis.com.
 
                               #  #  #
 
Media contacts
 
John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 79 596 1408 (mobile)
john.gilardi@novartis.com
 
Eric Althoff
Novartis Vaccines and Diagnostics Communications
+1-510-923-6500
+1-510-387-7604(US mobile)
eric.althoff@novartis.com
 
e-mail: media.relations@novartis.com or
nvd.communications@novartis.com
 
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Investor Relations
 
International
 
Ruth Metzler-Arnold +41 61 324 7944
Katharina Ambühl    +41 61 324 5316
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e-mail: investor.relations@novartis.com
 
References
[1] WHO Cumulative Number of Confirmed Human Cases of Avian
Influenza, WHO Web site
http://www.who.int/csr/disease/avian_influenza/
country/cases_table_2006_10_31/en/index.html, accessed February 6,
2007
[2] WHO Strategic Action Plan for Pandemic Influenza 2006-2007, WHO
website http://www.who.int/csr/resources/publications/
influenza/WHO_CDS_EPR_GIP_2006_2c.pdf, accessed February 6, 2007
 
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