Novartis vaccine Bexsero® sees high uptake in first large-scale public vaccination program to help protect against devastating meningitis B

Novartis News Release:

July 29, 2014 07:15 CET

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Novartis vaccine Bexsero® sees high uptake in first large-scale public vaccination program to help protect against devastating meningitis B

• Program in Québec's Saguenay-Lac-Saint-Jean region is the first public campaign globally to offer Bexsero to all from 2 months to 20 years of age[1]
• More than 45,000 infants, young children and adolescents included in the program have already received at least one dose of Bexsero[2] 
• Swift implementation, within 6 months of approval, marks a milestone in helping to protect at-risk groups, particularly infants and adolescents, against meningitis B

Basel, July 29, 2014 - Novartis has announced the initial results of a large-scale vaccination campaign with Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) to help protect against meningitis B within the Saguenay-Lac-Saint-Jean region of Québec, Canada. This public program adds to the growing real-world experience of Bexsero, which is approved in 34 countries, including the European Union, Australia and Canada[3],[4],[5],[6].

This regional program is the first of its kind globally and has reached 81% of the campaign's target population within the first three months[2]. This encompasses more than 45,000 infants, young children and adolescents from 2 months to 20 years of age[2]. The high rate of uptake in this public vaccination program with Bexsero demonstrates the value placed on preventing meningitis B within communities that are afforded access.

"A high level of uptake through a public vaccination program is critical to achieving community-wide protection against a devastating and unpredictable disease like meningitis B," said Andrin Oswald, Division Head, Novartis Vaccines. "Thanks to the decisive leadership and urgency with which the public health officials in Québec have acted, lives will likely be saved. We are committed to continuing to work with health authorities globally to ensure public access to Bexsero."

Ninety-four percent of Québec's invasive meningococcal disease cases in those aged 1-24 years old were caused by meningitis B between 2009 and 2011[7]. In the past few years, the number of people infected with meningitis B has been higher in the Saguenay-Lac-Saint-Jean region than in other Québec regions, relative to the population[1]. The decision to implement this vaccination campaign in the region was based on experts' recommendations, following Bexsero's approval in Canada in December 2013 for use in individuals from 2 months to 17 years of age[1],[6]. Second doses of Bexsero will be available in the fall of this year and the program will conclude on December 31, 2014[2].

Bexsero is the first broad coverage vaccine to help protect against meningitis B[8]. Since its launch in 2013, over half a million doses have been shipped worldwide[9]. Bexsero was also recently provided in the US to students at Princeton University and the University of California, Santa Barbara (UCSB) under a treatment Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) in response to local meningitis B outbreaks on both campuses[10],[11]. In June 2014, Novartis submitted a Biologic License Application (BLA) to the FDA for US marketing approval of Bexsero, which initiated a rolling submission process, following the receipt of a Breakthrough Therapy designation in April 2014.

Meningitis B is a rare but aggressive disease and is the leading cause of meningococcal disease and septicemia in the developed world[12],[13]. Meningitis B can kill or cause serious, life-long disabilities within 24 hours of symptom onset, leaving little time for intervention[12]. Vaccination is therefore the best defense against this devastating disease.

Meningococcal disease is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y)[14]. Prior to the development of Bexsero, vaccines were only available for four of these serogroups, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against all five serogroups, which together cause the majority of cases in the world[14],[15].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "to offer," "growing," "will," "committed," "initiated," or similar terms, or by express or implied discussions regarding potential 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 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 approved for sale in any market, 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, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; 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, 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 amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visithttp://www.novartis.com.

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References
[1] Sante et Services Sociaux. Vaccination. Available athttp://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?accueil_en. Accessed July 2014.
[2] Agence de la santé et des services sociaux du Saguenay-Lac-Saint-Jean. First wave of vaccination against meningococcal B (press release). June 19, 2014. Available at:http://www.csrsaguenay.qc.ca/medias/csrsaguenay/fichiers/Actualite/Communique_fin_campagne_printemps_140618_3.pdf. Accessed July 2014.
[3] European Medicines Agency. 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 July 2014. 
[4] European Medicines Agency. 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 July 2014. 
[5] Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed July 2014. 
[6] 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 June 2014. 
[7] Gilca et al. The Changing Epidemiology of Meningococcal Disease in Quebec, Canada, 1991-2011: Potential Implications of Emergence of New Strains. November 2012. Available athttp://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0050659. Accessed June 2014.
[8] Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria meningitidis vaccine. Expert Opinion on Biological Therapy. 2005, 5: 1611-1625. Available at:http://informahealthcare.com/doi/abs/10.1517/14712598.5.12.1611. Accessed July 2014.
[9] Novartis Data on File.
[10] Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at:http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed June 2014. 
[11] 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 June 2014.
[12] World Health Organization. Meningococcal Disease Fact Sheet 141. Available at:http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed April 2014.
[13] Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 12th Edition, 2nd printing. May 2012 update. Available at:http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed April 2014.
[14] Immunization Action Coalition. Meningitis: Questions & Answers. Available at:http://www.immunize.org/catg.d/p4210.pdf. Accessed June 2014.
[15] Harrison LH. Prospects for Vaccine Prevention of Meningococcal Infection. Clinical Microbiology Reviews. 2006; 19(1):142-1643. Available at:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360272/. Accessed June 2014.

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