Bexsero®: First Vaccine to Prevent Meningococcal Serogroup B (MenB) Now Available in Canada

February 26, 2014

DORVAL QC, Feb. 26, 2014 /CNW/ – Novartis announced today that Bexsero(®) (Multicomponent Meningococcal B Vaccine [recombinant, adsorbed]) is now
available to doctors and pharmacists across Canada. The vaccine is
approved for use in individuals from two months through 17 years of age
in Canada. Infants, toddlers and adolescents are at the greatest risk
of meningococcal serogroup B (MenB) infection.(1) Bexsero(®) is the first broad-coverage vaccine to help protect against MenB
disease.(1,2) Prior to Bexsero(®), vaccines were only available to help protect against meningococcal
strains A, C, W and Y.(3)

“Bexsero(®) is an important milestone in the fight against meningococcal disease,
offering Canadian families protection against MenB, the remaining and
most common strain of the disease,” said Dr. Ron Gold, Senior Medical
Advisor for the Meningitis Research Foundation of Canada and retired
Chief of Infectious Disease at The Hospital for Sick Children in
Toronto. “Canadian parents now have peace of mind knowing that they
have access to this vaccine to help protect their families from a
disease that can progress rapidly, affecting anyone at any time.”

About Meningococcal B Disease

MenB infection is the most common strain of meningococcal disease across
Canada, particularly in infants.(4 )It is responsible for 80 per cent of meningococcal cases in infants
under one year of age, 67 per cent in one to four year olds and 62 per
cent of the cases in adolescents aged 15 to 19.(4) Although rare, this disease can affect healthy people rapidly and
without warning.(5) Meningococcal disease can cause mortality in 24 to 48 hours and
symptoms can often resemble the flu, making this disease initially
misdiagnosed in its early stages.(5)

Kate Healy experienced first-hand the terrible effects of meningitis
when she contracted MenB in 2012. Now at 18 years of age, this vibrant
teenager lives an active life filled with potential. “As a survivor of
meningitis myself, I know the tough and unpredictable challenges that
other survivors and their families have to go through,” said Healy. “I
am extremely thankful to know that now, there is a vaccine available
that will help protect other children and their families from such a
devastating disease.”

To learn more about MenB and Bexsero(®), Canadians are encouraged to speak to their doctor.

About Bexsero(®)

Bexsero(®) is the result of more than 40 years of pioneering vaccine research.(6 )The tolerability profile and immunogenicity of Bexsero(®) have been established through a comprehensive clinical program
involving infants, children, adolescents and adults.(2) Bexsero(®) was approved by Health Canada in December 2013 and is also authorized
for use in Europe and Australia.

Bexsero(®) provides a flexible option that can fit into different vaccination
schedules.(7,8) When given with other routine infant vaccinations there is little
impact on immunogenicity of Bexsero(®) or the other vaccines.(7,8)

The availability of Bexsero(®) underscores the unique leadership position of Novartis in the global
fight against devastating meningococcal disease. Together, Bexsero(®) and Menveo(®) help to protect against all five main serogroups of meningococcal
bacteria (A, C, W, Y and now B) that cause virtually all cases around
the world.(3)

About Novartis Inc.

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.

Novartis Pharmaceuticals Canada Inc. is a subsidiary of Novartis AG,
which 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 129,000 full-time-equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.

(®) Bexsero and Menveo are registered trademarks.


(1) Novartis Bexsero Canada Approval Press Release. Accessed January 2014.
Available at: http://www.novartis.ca/downloads/en/News/FINAL_Press_Release_Bexsero_12-06-13_E.pdf.

(2) BEXSERO* Product Monograph. Novartis Pharmaceuticals Canada Inc.,
December, 2013

(3) Perrett KP, Pollard AJ. Towards An Improved Serogroup B Neisseria
Meningitidis Vaccine. Expert Opin Biol Ther. 2005;5:1611-1625. Accessed
on August 24, 2013. Available at: http://informahealthcare.com/doi/abs/10.1517/147.12598.5.12.1611.

(4) National Advisory Committee on Immunization. (2013) Update on the use
of Quadrivalent Conjugate

Meningococcal Vaccines. Canada Communicable Disease Report. January
2013; Vol. 39, ACS-1: 1-40

(5) Harrison LH. Prospects for Vaccine Prevention of Meningococcal
Infection. Clin Microbiol Rev. 2006; 19(1):142-1643. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360272/pdf/002.

(6) Rappuoli, R. Reverse Vaccinology, A Genome-Based Approach to Vaccine
Development. Vaccine. 2001; 19: 2688-2691. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11257410

(7) Gossger N et al. (2012) Immunogenicity of Recombinant Serogroup B
Meningococcal Vaccine Administered With or Without Routine Infant
Vaccinations According to Different Immunization Schedules: A
Randomized Controlled Trial. JAMA 307(6):573-82.

(8) Vesikari, T et al., Immunogenicity and Safety of an Investigational
Multicomponent, Recombinant, Meningococcal Serogroup B vaccine (4CMenB)
Administered Concomitantly with Routine Infant and Child Vaccinations:
Results ofTtwo Randomised Trials. Lancet, 2012; Vol 381. Available at: http://dx.doi.org/10.1016/S0140-6736(12)61961-8

SOURCE Novartis Pharmaceuticals Canada Inc.

Source: PR Newswire

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