Click here to close now.

Welcome!

.NET Authors: Elizabeth White, Liz McMillan, Greg O'Connor, Jason Bloomberg, Jayaram Krishnaswamy

News Feed Item

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

 

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
How is unified communications transforming the way businesses operate? In his session at WebRTC Summit, Arvind Rangarajan, Director of Product Marketing at BroadSoft, will discuss how to extend unified communications experience outside the enterprise through WebRTC. He will also review use cases across different industry verticals. Arvind Rangarajan is Director, Product Marketing at BroadSoft. He has over 19 years of experience in the telecommunications industry in various roles such as Software Development, Product Management and Product Marketing, applied across Wireless, Unified Communic...
Health care systems across the globe are under enormous strain, as facilities reach capacity and costs continue to rise. M2M and the Internet of Things have the potential to transform the industry through connected health solutions that can make care more efficient while reducing costs. In fact, Vodafone's annual M2M Barometer Report forecasts M2M applications rising to 57 percent in health care and life sciences by 2016. Lively is one of Vodafone's health care partners, whose solutions enable older adults to live independent lives while staying connected to loved ones. M2M will continue to gr...
Dave will share his insights on how Internet of Things for Enterprises are transforming and making more productive and efficient operations and maintenance (O&M) procedures in the cleantech industry and beyond. Speaker Bio: Dave Landa is chief operating officer of Cybozu Corp (kintone US). Based in the San Francisco Bay Area, Dave has been on the forefront of the Cloud revolution driving strategic business development on the executive teams of multiple leading Software as a Services (SaaS) application providers dating back to 2004. Cybozu's kintone.com is a leading global BYOA (Build Your O...
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements around Unified Networks, Cloud Computing strategies, Virtualization around Software defined Data Ce...
What exactly is a cognitive application? In her session at 16th Cloud Expo, Ashley Hathaway, Product Manager at IBM Watson, will look at the services being offered by the IBM Watson Developer Cloud and what that means for developers and Big Data. She'll explore how IBM Watson and its partnerships will continue to grow and help define what it means to be a cognitive service, as well as take a look at the offerings on Bluemix. She will also check out how Watson and the Alchemy API team up to offer disruptive APIs to developers.
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquired by Aditi Technologies. He is a Microsoft Regional Director for Hyderabad, India, and one of the f...
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
SYS-CON Events announced today that SoftLayer, an IBM company, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place June 9-11, 2015 at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place November 3–5, 2015 at the Santa Clara Convention Center in Santa Clara, CA. SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from ...
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, has been named "Silver Sponsor" of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York, NY. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make smarter decisions, faster.
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, phone and digital TV services to consumers primarily in rural areas.
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will meet your customers' needs of tomorrow - today! Ciqada. Let your products take flight. For more inform...
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY., and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool f...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applications - creating more engaging experiences for their customers and boosting collaboration and productiv...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
SYS-CON Events announced today that Open Data Centers (ODC), a carrier-neutral colocation provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Open Data Centers is a carrier-neutral data center operator in New Jersey and New York City offering alternative connectivity options for carriers, service providers and enterprise customers.
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Company’s core communications platform enables the delivery of a range of enterprise and consumer calling...
SYS-CON Events announced today that On the Avenue Marketing Group, a sales and marketing firm that utilizes events to market and sell products to consumers, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. On the Avenue Marketing Group (OTA) is a sales and marketing firm that utilizes events to market and sell products to consumers. On behalf of our clients, we attend thousands of fairs, festivals, expos, concerts, conferences, and sporting events annually, helping them reach millions of individuals ...
SYS-CON Events announced today that ActiveState, the leading independent Cloud Foundry and Docker-based PaaS provider, has been named “Silver Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. ActiveState believes that enterprises gain a competitive advantage when they are able to quickly create, deploy and efficiently manage software solutions that immediately create business value, but they face many challenges that prevent them from doing so. The Company is uniquely positioned to help address these challenges thro...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.