Novartis International AG : Pivotal study in The Lancet shows potential of Novartis vaccine Bexsero® to help provide broad

  Novartis International AG : Pivotal study in The Lancet shows potential of
Novartis vaccine Bexsero® to help provide broad protection to infants against

Novartis International AG / Pivotal study in The Lancet shows potential of
Novartis vaccine Bexsero® to help provide broad protection to infants against
MenB . Processed and transmitted by Thomson Reuters ONE. The issuer is solely
responsible for the content of this announcement.

  *Phase III results show that Bexsero induced a robust immune response when
    administered concomitantly with routine vaccines, and also as a booster

  *Data confirm Bexsero's acceptable safety and tolerability profile in
    infants, who are among the most vulnerable to MenB, a leading cause of

  *Bexsero was recommended for European licensure in November 2012; upon
    approval, Bexsero will be the first and only broad coverage vaccine
    against MenB

Basel, January  14, 2013-  TheLancet published  findings online  today from  a 
pivotal Phase III clinical trial  of Bexsero^® (Meningococcal Group B  Vaccine 
[rDNA, component, adsorbed]) involving 3,630  infants from two months of  age. 
The study showed that  Bexsero demonstrated a  protective immune response  and 
has an acceptable  safety profile  when administered as  a three-dose  primary 
series concomitantly with routine vaccines. The investigators also observed  a 
robust booster  response in  toddlers  to a  fourth  dose administered  at  12 
months, which may contribute to an extended duration of protection. These data
were first presented in 2010  at the 17^th International Pathogenic  Neisseria 
Conference (IPNC)[2].

"As a practicing pediatrician, I see  how devastating MenB is for infants  and 
toddlers, as well as the  agony for their families. It  is a disease that  can 
strike with little warning  and progress very rapidly,  even when parents  are 
quick to respond," said Prof. Susanna Esposito, Pediatric Clinic 1, Fondazione
IRCCS Ca' Granda Ospedale Maggiore Policlinico, Department of  Pathophysiology 
and Transplantation, Università  degli Studi di  Milano, Italy, and  Committee 
Member of the European Society for Pediatric Infectious Disease. "The prospect
of a new vaccine that helps to prevent  MenB is the advance that we have  been 
awaiting for decades."

In November  2012,  Bexsero was  recommended  for European  licensure  by  the 
Committee for  Medicinal  Products  for  Human  Use  (CHMP)  of  the  European 
Medicines  Agency  (EMA).The  European   Commission  generally  follows   the 
recommendations of  the CHMP  and  delivers its  final decision  within  three 
months, which  will be  applicable to  all European  Union (EU)  and  European 
Economic Area  (EEA)  countries.  Novartis  is  committed  to  making  Bexsero 
available as  soon  as  possible  and is  already  engaging  with  governments 
interested in the early adoption of the vaccine.

"Our company has made a strong commitment to addressing the public health need
for a vaccine  that can provide  broad protection against  MenB. The  findings 
from this and other studies have built a substantial body of evidence  showing 
that Bexsero can be  an effective vaccine against  this deadly disease,"  said 
Andrin Oswald, Division  Head, Novartis  Vaccines and  Diagnostics. "Upon  the 
licensure of Bexsero, Novartis will be able to offer vaccines to help  prevent 
all five of the most common and most virulent meningococcal serogroups."

Meningococcal disease is  easily misdiagnosed and  kills approximately one  in 
ten people within 24 hours  of onset despite appropriate treatment[3],[4].  Of 
the survivors, around one in five suffers permanent disabilities such as brain
damage, hearing  impairment  or  limb loss[5].  Therefore  prevention  through 
vaccination is the best means to  reduce the burden of meningococcal  disease. 
The majority  of cases  in the  developed world  are due  to MenB[6],  with  a 
disproportionate disease burden in infants[7].

Study Design and Results
This pivotal  (Phase III)  immunogenicity study  randomized 3,630  infants  to 
receive routine vaccines at 2, 4  and 6 months, either alone or  concomitantly 
with either Bexsero or a serogroup  C conjugate vaccine. The routine  vaccines 
administered were 7-valent pneumococcal glycoconjugate vaccine and a  combined 
diphtheria, tetanus, acellular pertussis,  inactivated polio, hepatitis B  and 
Haemophilus influenzae type b vaccine[1].

Immune response against each of the four vaccine components (fHbp, NadA,  OMV, 
and NHBA)  was measured  using the  human serum  bactericidal antibody  (hSBA) 
assay with a pre-defined threshold titer of >=1:5, the accepted correlate  for 

A total of 1,555 toddlers were enrolled in the booster phase of the study  and 
randomized to  receive either  a Bexsero  booster  dose at  the same  time  as 
measles-mumps-rubella-varicella (MMRV) vaccine, or  given the Bexsero  booster 
alone at 12 months and MMRV given one month later.

Following the  booster  dose  of  Bexsero  at 12  months,  more  than  95%  of 
recipients showed  a  protective  response to  all  four  vaccine  components. 
Furthermore, one month after the third dose, all infants in the study showed a
100% protective antibody response against two vaccine components (fHbp,  NadA) 
and 84%  against the  other two  components (NHBA,  OMV). These  findings  are 
important given  that  the  burden  of  disease  is  highest  in  infants  and 

In this study, Bexsero was shown  not to interfere with the immunogenicity  of 
any other vaccine it was administered with, except for a slightly lower immune
response to  polio vaccine  that the  investigators concluded  was not  to  be 
clinically meaningful[1].

Bexsero had an acceptable tolerability profile when co-administered with other
routine infant vaccinations. During the  primary series, local injection  site 
reactions (e.g., tenderness) and fever  occurred more frequently when  Bexsero 
was co-administered with routine vaccines than when the routine vaccines  were 
given alone.  When  fever  occurred,  it  was  generally  mild-to-moderate  in 
severity and of short duration, with the majority of cases resolving within 24
hours. During  the booster  phase, the  frequency of  fever was  similar  when 
Bexsero was administered alone to when it was co-administered with MMRV[1].

About Bexsero
Bexsero,  an  investigational   multicomponent  meningococcalgroupB   (MenB) 
vaccine, is the result of more than 20 years of pioneering research in vaccine
development[8]. MenB has beena particularly elusive target because  theouter 
coating of thebacteria  is notwell recognized  by the immune  system,making 
itespecially challengingto develop a broadly effective vaccineuntil  recent 
advances  in  scientific   knowledge[9].  Bexsero  was   developed  using   an 
award-winning scientificapproachthat  involveddecodingthe  genetic  makeup 
(genome  sequence)  of  MenB[8],[9].This  innovative  approach  provides   the 
foundation for the potential development of a new generation of vaccines  that 
may  help   prevent   other  diseases   with   a  significant   diversity   of 
disease-causing strains.

Upon regulatory approval, Bexsero will be the first and  onlylicensedvaccine 
with  the  potential  to  protect  against  a  broad  range  of  strains  that 
causeMenBdisease worldwide[10]. The tolerability profile and  immunogenicity 
of Bexsero  have been  established through  a comprehensive  clinical  program 
including data from large Phase II/III clinical trials involving almost  8,000 
patients[1],[11],[12],[13],[14],[15], including infants,the age groupat  the 
greatest risk of infection.  Starting from two months  of age, Bexsero  offers 
severalimmunizationschedule options  that can  fitwithroutine  vaccination 

The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "recommended," "will,"
"prospect," "generally follows . and delivers," "committed," "commitment,"
"can," "may," or similar expressions, or by express or implied discussions
regarding potential marketing approvals for Bexsero or any other vaccines, or
the timing of any such approvals, or regarding potential future revenues from
any such vaccines. 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 or any
other vaccines will be approved for sale in any market, or at any particular
time. Nor can there be any guarantee that Bexsero or any other vaccines 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; competition in general;
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 
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

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1.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
2.Vesikari T, et al. Immunogenicity of an investigational multicomponent
    meningococcal serogroup B vaccine in healthy infants at 2, 4 and 6 months
    of age. Presented at the 17th International Pathogenic Neisseria
    Conference, 11-16 September 2010; Banff, Canada.
3.Thompson MJ, et al. Clinical recognition of meningococcal disease in
    children and adolescents. Lancet 2006;367:397-403.
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    November 2012 update. Available at: Last accessed 10 Dec
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6.Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
    meningitidis vaccine. Expert Opin Biol Ther 2005;5:1611-25.
7.Centers for Disease Control and Prevention. Meningococcal Disease - Age as
    a risk factor. Available at: Last accessed 10 Dec
8.Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
    development. Vaccine 2001;19:2688-91.
9.Giuliani MM, et al. A universal vaccine for serogroup B meningococcus.
    Proc Natl Acad Sci USA 2006;103:10834-9.
10.Donnelly J, et al. Qualitative and quantitative assessment of
    meningococcal antigens to evaluate the potential strain coverage of
    protein-based vaccines. Proc Natl Acad Sci USA 2010;107:19490-5.
11.Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent
    meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in
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12.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.
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    trial of an investigational recombinant meningococcal serogroup B vaccine
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    meningococcal vaccines in the first year of life: a randomized comparative
    trial. Pediatr Infect Dis J 2010;29:e71-9.
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    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.

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