CAMBRIDGE, Mass., Dec. 9, 2013 /PRNewswire/ -- Princeton University has announced that a vaccination program with Novartis meningococcal serogroup B (MenB) vaccine, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), began today following a campus outbreak that has affected at least eight students. Currently authorized for use in Europe, Australia and Canada, the US Food and Drug Administration (FDA) approved a treatment Investigational New Drug (IND) application filed by the US Centers for Disease Control and Prevention (CDC) for the use of Bexsero on the Princeton campus to help prevent further spread of this serious and unpredictable disease1,2,3,4,5. Bexsero is the first and only broad coverage vaccine to help protect against MenB.
Rare but devastating, MenB is a bacterial infection that progresses rapidly and can lead to death or permanent disability within 24 hours of symptom onset6,7. Because initial symptoms are often unspecific and flu-like, it can be difficult for even a healthcare professional to diagnose the disease in its early stages. About one in 10 of those with the disease will die despite treatment; and of those who do survive, one in five will suffer from devastating, life-long disabilities such as brain damage, hearing loss, or limb loss7.
"Over the last few weeks, we have been working closely with officials at Princeton and the CDC to put in place a timely and decisive response to the outbreak. This situation serves as a reminder that MenB can strike anyone at any time," said Andrin Oswald, Division Head, Novartis Vaccines. "Novartis is committed to continuing the dialogue with the FDA to find a licensure pathway to bring a MenB vaccine to the US to fulfill this unmet public health need for the future."
The vaccinations with Bexsero began today, December 9, 2013. Under the CDC guidelines, the vaccine is recommended for all Princeton University undergraduate students (those who live in dormitories or off-campus) as well as graduate students who live in dormitories1,2. Princeton officials and local health authorities will continue to monitor the disease.
Novartis has completed Phase I and Phase II studies for Bexsero in the US. The Company has also submitted data involving almost 8,000 infants, children, adolescents and adults, which supported the licensure in Europe, to the FDA for consideration1. In addition, Novartis continues to work with the FDA to advance a single vaccine for the protection against five of most common serogroups that cause meningococcal disease (A, B, C, Y and W).
The foregoing release contains forward-looking statements that can be identified by words such as "potentially," "will," "committed," "continues," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero, or regarding potential approvals of other meningococcal vaccines, 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 materialize, 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 the US or additional markets, or at any particular time. Nor can there be any guarantee that any other meningococcal vaccines will be submitted or approved for sale in any country, or at any particular time. Neither can there be any guaranty that Bexsero or such other products will be commercially successful in the future. In particular, management's expectations regarding these products 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; unexpected manufacturing issues; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions, 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.
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 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 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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- Centers for Disease Control and Prevention. Serogroup B Meningococcal Vaccine Questions and Answers. Available at: http://www.cdc.gov/meningococcal/vaccine-serogroupB.html. Accessed November 2013.
- Princeton University. Meningitis Information. Available at: http://web.princeton.edu/sites/emergency/meningitis.html#FAQ. Accessed November 2013.
- 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 November 2013.
- 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 November 2013.
- Australian Register of Therapeutic Goods. Bexsero Public Summary. Available at: https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=23D464570B085A6CCA257C21003CAB43&agid=(PrintDetailsPublic)&actionid=1. Accessed November 2013.
- Mayo Foundation for Medical Education and Research. Meningitis. April 2011. Available at: http://www.mayoclinic.com/health/meningitis/DS00118/DSECTION=symptoms. Accessed November 2013.
- World Health Organization. Meningococcal meningitis. Fact sheet #141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed November 2013.
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