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Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero® to help protect US adolescents and young adults

June 17, 2014

Submission follows receipt of Breakthrough Therapy designation in April 2014, highlighting unmet need for a licensed vaccine for serogroup B in the US(1)

BASEL, Switzerland, June 17, 2014 /PRNewswire/ — Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero(®) (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April.

“Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases,” said Andrin Oswald, Division Head, Novartis Vaccines. “With today’s submission, we are one step closer to ensuring that no family in the US has to endure the loss of a loved one from vaccine-preventable meningitis.”

Bexsero is the first broad coverage vaccine to help protect against meningitis B(11). The vaccine is already approved in 34 countries including across the European Union, Canada and Australia(5,6,7,8). Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide(12).

In the US, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the FDA(9,10,12). Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero(13).

Meningococcal disease can be easily misdiagnosed and while rare, it can have serious consequences, including life-long disability and death within the first 24 hours of symptom onset(2,3,4). It 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 the five serogroups of the meningococcus, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against these serogroups that together cause the majority of cases in the world(14,15).

Novartis is committed to working with US health authorities to help provide access to Bexsero for all at-risk groups. Meningococcal disease can have tremendous impact on individuals and their families. Vaccination is the best defense against a disease that can be aggressive, and leave little time for intervention.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as “submits,” “submission,” “Breakthrough Therapy,” “can,” “initiates,” “recommended,” “to receive,” “committed,” or similar terms, or by express or implied discussions regarding potential marketing approval 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, 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; 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 visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

    1. 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 June
       2014.
    2. KidsHealth.org. Meningitis. Available at:
       http://kidshealth.org/parent/infections/lung/meningitis.html. Accessed
       June 2014.
    3. National Meningitis Association. "What are the Symptoms?" Available at:

http://www.nmaus.org/disease-prevention-information/what-are-the-symptoms

       . Accessed June 2014.
    4. World Health Organization. Meningococcal meningitis fact sheet. Available
       at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html.
       Accessed June 2014.
    5. European Medicines Agency. Authorization Details for Bexsero. Available
       at:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicin

       es/002333/human_med_001614.jsp&mid=WC0b01ac058001d124. Accessed June
       2014.
    6. European Medicines Agency. EU Member States. Available at:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/g

       eneral/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed June
       2014.
    7. Health Canada. Bexsero. Available at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_b

       exsero_147275-eng.php. Accessed June 2014.
    8. Australian Government: Department of Health: Therapeutic Goods
       Administration. Available at:

http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf.

       Accessed June 2014.
    9. 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.
    10. 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.
    11. 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 June 2014.
    12. Novartis data on file.
    13. Princeton University. Emergency Guidelines for the Campus Community.
        Meningitis Information for Admitted Students.

http://web.princeton.edu/sites/emergency/meningitis/FAQ-Admitted.html.

        Accessed June 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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