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Pivotal study in The Lancet shows potential of Novartis vaccine Bexsero to help provide broad protection to infants against MenB

• Phase III results show that Bexsero induced a robust immune response when administered concomitantly with routine vaccines, and also as a booster dose[1]

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

• 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 - The Lancet 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 17th 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 protection[1].

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 toddlers[1].

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 meningococcal group B (MenB) vaccine, is the result of more than 20 years of pioneering research in vaccine development[8]. MenB has been a particularly elusive target because the outer coating of the bacteria is not well recognized by the immune system, making it especially challenging to develop a broadly effective vaccine until recent advances in scientific knowledge[9]. Bexsero was developed using an award-winning scientific approach that involved decoding the 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 only licensed vaccine with the potential to protect against a broad range of strains that cause MenB disease 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 group at the greatest risk of infection. Starting from two months of age, Bexsero offers several immunization schedule options that can fit with routine vaccination visits.

Disclaimer
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 http://www.novartis.com.

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References

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 print].
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.
4. World Health Organization. Meningococcal meningitis. Fact sheet #141. November 2012 update. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 10 Dec 2012.
5. Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001;344:1378-88.
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: http://www.cdc.gov/meningococcal/about/risk-age.html. Last accessed 10 Dec 2012.
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 Chile. Lancet 2012;379:617-24.
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.
13. 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.
14. 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.
15. 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.

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Posted: January 2013

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