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Novartis Bexsero®▼ Meningitis B Vaccine Receives Clinical Recommendation for Use in Infants and Adolescents in Australia

FRIMLEY, England, March 13, 2014 /PRNewswire/ --



  • Australian recommendation adds to clinical recommendations in the Czech Republic, Poland and funding decisions in regions of Germany and Italy
  • Recommendations highlight support for inclusion of Bexsero on routine childhood immunisation schedules to help protect against this devastating disease
  • Bexsero is licensed in the EU, Canada and Australia and has been available privately since 2013, with more than 500,000 doses shipped to date[1],[2],[3],[4],[5]

Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a clinical recommendation for the vaccine's routine use to help protect against meningitis B. These recommendations follow recent access milestones for Bexsero in multiple regions across Europe, including some regions of Italy and Germany. Bexsero is the only broad coverage vaccine to help protect against meningitis B, a potentially deadly disease that disproportionately affects infants and adolescents[6],[7].

Australia's advisory body on immunisation matters, the Australian Technical Advisory Group on Immunisation (ATAGI), has recommended Bexsero for all young Australians, with an emphasis on infants and children under 2 years of age and adolescents 15-19 years of age[8]. Inclusion in the National Immunisation Program is under consideration.

In Europe, Bexsero continues to gain endorsements from health authorities and experts:

  • In Italy, the Basilicata region recommends Bexsero for the routine vaccination of infants and will have an active call to parents that includes providing the vaccine free of charge. The Board of Calendario per la Vita, comprised of the country's foremost scientific societies, has recommended Bexsero for all infants with three doses in the first year of life and one dose at 13 months of age[9].
  • In Germany, more than 35 statutory sickness funds (semi-public health insurance providers) have chosen to voluntarily reimburse Bexsero for all children (ages 2 months to 18 years). Bexsero is also recommended by the German Academy of Child and Adolescent Medicine (DAKJ), a leading paediatric association[10],[11].
  • Poland has a clinical recommendation for routine vaccination with Bexsero for infants, children and adolescents (starting at 2 months of age)[12].
  • In addition, the Czech Vaccinology Society has recommended vaccination with Bexsero for infants, toddlers and children (aged 2 months to 10 years), adolescents (ages 13-15 years) and other high-risk individuals[13].

"For a vaccine-preventable disease, every child lost or disabled is one too many," said Andrin Oswald, Division Head, Novartis Vaccines. "These regional milestones are a testament to the public health benefits of Bexsero and we are hopeful that governments around the world will continue to act with a sense of urgency to help protect those most vulnerable from the devastation of meningitis B."

Meningitis B is a rare but aggressive and often deadly disease; it is the leading cause of meningococcal disease and septicaemia in the developed world[6],[14]. Meningitis B can kill or cause serious life-long disabilities within 24 hours of onset, leaving little time for intervention[14]. Vaccination is therefore the best defence against this aggressive disease.

Bexsero is the only licensed broad coverage vaccine approved in the European Union, Canada and Australia to help protect against meningitis B[1],[2],[3],[4], and has been available privately since 2013 in an ever-increasing number of countries with more than 500,000 doses shipped to date[5]. Bexsero was also recently provided to students at Princeton University and the University of California Santa Barbara (UCSB) in the United States (US) under an Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) which was issued in response to meningitis B outbreaks on these campuses[15],[16]. To date, over 30,000 doses of Bexsero have been distributed in the US[17].

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "recommendation," "recommendations," "potentially," "recommended," "under consideration," "continues," "recommends," "will," "call," "hopeful," "continue," "can," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Bexsero will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Bexsero will be commercially successful 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; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortisation charges). Novartis Group companies employ approximately 136,000 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. EMA. Authorization Details for Bexsero. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp& mid=WC0b01ac058001d124. Accessed March 2014.
  2. EMA. EU Member States. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed March 2014.
  3. Health Canada. Bexsero. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php. Accessed March 2014.
  4. Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed March 2014.
  5. Novartis Data on File.
  6. World Health Organization. Meningococcal Meningitis. Fact sheet 141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html. Accessed March 2014.
  7. Cohn, A. et al. Changes in Neisseria meningitides Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases 2010:50. Accessed March 2014.
  8. Australian Technical Advisory Group on Immunisation. Advice for immunisation providers regarding the use of Bexsero. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/85A6879534C02B4DCA257B640002F38E/$File/ATAGI-advice-bexsero.pdf. Accessed March 2014.
  9. Proposta del Board del 'Calendario per la Vita' (Sltl, SIP, FIMP e FIMMG) sull'inserimento del vaccine anti-meningococco B nel calendario delle vaccinazioni dell'infanzia. Available at: http://www.panoramasanita.it/docs/documentocongiuntositifimpsipfimmg.pdf. Accessed on March 2014.
  10. Novartis Data on File.
  11. Deutsche Akademie fur Kinder - und Jugendmedizin E.V. Impfprophylaxe invasiver Erkrankungen mit Meningokokken der Serogruppe B. Available at: http://dakj.de/media/stellungnahmen/infektionskrankheiten-impffragen/2013-meningokokkenB-impfprophylaxe.pdf. Accessed March 2014.
  12. Poland Ministry of Health. W sprawie Programu Szczepień Ochronnych na rok 2014. http://www.gis.gov.pl/ckfinder/userfiles/files/EP/informacje%20dla%20podr%C3%B3%C5%BCuj%C4%85cych/PSO%202014.pdf. Accessed March 2014.
  13. Novartis Data on File.
  14. World Health Organization. Bacterial Meningitis. Available at: http://apps.who.int/nuvi/meningitis/en/. Accessed March 2014.  
  15. Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at: http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed March 2014.
  16. Centers for Disease Control and Prevention. University of California, Santa Barbara Meningococcal Disease Outbreak. January 2014. Available at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed March 2014.
  17. Novartis Data on File.

 

UK/BEX/14-0018    
Date of preparation: March 2014

 

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