Novartis International AG : Novartis receives EU approval for Bexsero®, first vaccine to prevent the leading cause of life

Novartis International AG : Novartis receives EU approval for Bexsero®, first
  vaccine to prevent the leading cause of life-threatening meningitis across
                                    Europe

Novartis International AG / Novartis receives EU approval for Bexsero®, first
vaccine to prevent the leading cause of life-threatening meningitis across
Europe . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.

  *Bexsero is indicated to help protect all age groups against  meningococcal 
    serogroup  B  (MenB)   disease,  including  infants   who  are  the   most 
    vulnerable[1]
  *MenB disease  is  associated with  a  high  human toll  for  families  and 
    communities,  as  it  can  be  fatal  or  may  cause  serious,   life-long 
    disabilities in survivors[2],[3]
  *Novartis is working with health authorities to provide access to Bexsero
    as soon as possible

Basel, January 22, 2013- Novartis announced today that the European Commission
has approved  Bexsero^®  (Meningococcal  Group  B  Vaccine  [rDNA,  component, 
adsorbed]) for use in individuals from 2 months of age and older. Novartis  is 
committed to making Bexsero available as soon as possible.

"This meningitis B vaccine is the  most important medical breakthrough in  the 
30 years since I lost my son to the disease," said Meningitis UK Founder Steve
Dayman MBE.  "It could  save  thousands of  lives  and prevent  other  parents 
suffering the same tragedy. The vaccine must be made widely available  through 
the immunisation schedule  as soon as  possible - any  delay could mean  lives 
lost."

MenB disease is a bacterial infection  and is the leading cause of  meningitis 
across Europe[4], particularly in infants[1].  Although rare, one reason  this 
disease is so  feared is that  it affects healthy  people rapidly and  without 
warning[2],[3]. Symptoms  can  often resemble  the  flu, making  this  disease 
easily misdiagnosed  in its  early stages[5].  In many  cases, doctors  simply 
cannot treat infected patients  soon enough to  avoid serious outcomes.  About 
one in ten  of those  who contract the  disease will  die despite  appropriate 
treatment[3]. Up  to  one  in  five survivors  may  suffer  from  devastating, 
life-long disabilities  such  as  brain damage,  hearing  impairment  or  limb 
loss[3]. Prevention through vaccination is therefore the best defense  against 
this aggressive disease.

"Each year, thousands of  parents see their children  die or left with  severe 
disabilities as a  result of  this devastating disease.  Through the  combined 
efforts of many people over two decades, we are closer than ever to seeing  an 
end to this suffering," said  Andrin Oswald, Division Head, Novartis  Vaccines 
and Diagnostics. "Our vision is a  world without meningitis, and our  priority 
is to work with  decision makers across  Europe to ensure  there is broad  and 
timely access to vaccination."

Following today's  approval,  EU  member  states  will  evaluate  Bexsero  for 
potential inclusion into national  immunization programs and, where  relevant, 
reimbursement  schemes.  Novartis   is  already   engaging  with   governments 
interested in the early adoption of the vaccine.

Bexsero is the result of more than 20 years of pioneering vaccine research[6],
and its tolerability profile and immunogenicity have been established  through 
a comprehensive clinical program involving infants, children, adolescents  and 
adults[7],[8],[9],[10],[11],[12]. Starting  at  two  months  of  age,  Bexsero 
offers several  immunization  schedule options  that  could fit  with  routine 
vaccination visits.

The approval of Bexsero underscores the unique leadership position of Novartis
in the  global  fight  against devastating  meningococcal  disease.  Together, 
Bexsero and  Menveo^® help  to protect  against all  five main  serogroups  of 
meningococcal bacteria (A, C, W-135, Y and  now B) that cause the majority  of 
cases around the world[13].

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "as soon as possible," "committed," "could,"
"vision," "priority," "will," "potential," or similar expressions, or by
express or implied discussions regarding the potential timing of the
availability of Bexsero to the public, or regarding potential future revenues
from Bexsero. You should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management regarding
future events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Bexsero to be materially different
from any future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that Bexsero will be available to
the public in any particular country at any particular time. Nor can there be
any guarantee that Bexsero will achieve any particular levels of revenue in
the future. In particular, management's expectations regarding Bexsero could
be affected by, among other things, unexpected regulatory actions or delays or
government regulation generally, including uncertainties as to whether Bexsero
will be included in particular countries' national immunization programs;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; government, industry
and general public pricing pressures; unexpected manufacturing issues; the
company's ability to obtain or maintain patent or other proprietary
intellectual property protection; 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 provides innovative  healthcare solutions that  address the  evolving 
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye  care,  cost-saving  generic  pharmaceuticals,  preventive  vaccines   and 
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global  company with  leading  positions in  these  areas. In  2011,  the 
Group's continuing operations achieved  net sales of  USD 58.6 billion,  while 
approximately USD  9.6  billion  (USD 9.2  billion  excluding  impairment  and 
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ  approximately  127,000 full-time-equivalent  associates  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    @Novartis    at 
http://twitter.com/novartis.

References

[1] Rosenstein NE, et al. Meningococcal disease. N Engl J Med
2001;344:1378-88.
[2] Thompson MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet 2006;367:397-403.
[3] World Health Organization. Meningococcal meningitis. Fact sheet #141.
November 2012 update. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 15 Jan
2013.
[4] World Health Organization. Meningococcal, staphylococcal and
streptococcal infections. Available at:
http://www.who.int/vaccine_research/documents/Meningo20091103.pdf. Last
accessed 15 Jan 2013.
[5] Mayo Foundation for Medical Education and Research. Meningitis. April
2011. Available at:
http://www.mayoclinic.com/health/meningitis/DS00118/DSECTION=symptoms. Last
accessed 15 Jan 2013.
[6] Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine 2001;19:2688-91.
[7] Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent
meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile.
Lancet 2012;379:617-24.
[8] Gossger N, et al. Immunogenicity and tolerability of recombinant
meningococcal serogroup B vaccine administered with or without routine infant
vaccinations according to different immunization schedules: A randomized
controlled trial. JAMA 2012;307:573-82.
[9] Vesikari T, et al. Immunogenicity and safety of an investigational
multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB)
administered concomitantly with routine infant and child vaccinations: results
of two randomised trials. Lancet 2013 Jan 14. [Epub ahead of print].
[10] Findlow J, et al. Multicenter, open-label, randomized phase II controlled
trial of an investigational recombinant meningococcal serogroup B vaccine with
and without outer membrane vesicles, administered in infancy. Clin Infect Dis
2010;51:1127-37.
[11] Snape MD, et al. Immunogenicity of two investigational serogroup B
meningococcal vaccines in the first year of life: a randomized comparative
trial. Pediatr Infect Dis J 2010;29:e71-9.
[12] Prymula R, et al. Catch-up vaccination of healthy toddlers with an
investigational multicomponent meningococcal serogroup B vaccine (4CMenB) -
exploration of a two-dose schedule. Presented at 29th ESPID Meeting, 7-11 June
2011; The Hague, The Netherlands.
[13] World Health Organization. Meningococcal position paper. Weekly
epidemiological record No. 44, 2002, 77, 329-40. Available at:
http://www.who.int/immunization/wer7740meningococcal_Oct02_position_paper.pdf.
Last accessed 15 Jan 2013.

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