- Australia approval marks a key step in expanding access to the first and only broad coverage vaccine against MenB disease,;Bexsero was granted European licensure this past January
- MenB disease is a leading cause of meningitis and sepsis globally, and causes approximately 85 percent of all meningococcal disease cases in Australia,,
- Bexsero safety and efficacy have been shown through clinical trials involving more than 8,000 people including infants, children, adolescents and adults
Basel, August 15, 2013 - Novartis announced today that the Australian Therapeutic Goods Administration (TGA) has added Bexsero®, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest risk of infection,.
Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen,. The introduction of vaccines for other strains of bacterial meningitis has been successful in reducing the disease burden in Australia; specifically, following the rollout of a national meningococcal serogroup C vaccination program in Australia, cases decreased from 162 in 2002 to nine by 2011,.
"Novartis welcomes the Australian health authorities' decision to license Bexsero, which is further testament to the vaccine's demonstrated robust efficacy and safety profiles and an important step in preventing further suffering caused by MenB disease," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "We are committed to bringing Bexsero to parents around the globe that want to protect their children against this devastating disease."
MenB is a potentially deadly disease which is easily misdiagnosed and can kill within 24 hours of onset. About one in 10 of those who contract the disease will die despite appropriate treatment. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss. The consequences for those affected and the healthcare system are significant.
"Today marks another victory, particularly for Australian children, parents and pediatricians, in the fight against meningococcal disease," said Bruce Langoulant, President and Asia Pacific Regional Leader, Confederation of Meningitis Organisations. "We are now entering a critical period for public health authorities to provide funding to include the new MenB vaccine in the routine immunization schedules to ensure community-wide protection against the tragic deaths and lasting disabilities MenB can cause."
As a next step, Novartis will work with Australian regulatory authorities to make doses of Bexsero available in the private market in the coming months. In parallel, the Pharmaceutical Benefits Advisory Committee (PBAC), taking into account advice from the Australian Technical Advisory Group on Immunisation (ATAGI), is expected to make recommendations regarding reimbursement and potential inclusion of Bexsero in the National Immunisation Program (NIP),.
In January 2013, Bexsero received marketing authorization from the European Commission which applies to all 28 European Union (EU) member states, Iceland, Liechtenstein and Norway,. With this TGA decision, Bexsero is now licensed in more than 30 countries and further regulatory filings are underway.
Meningococcal disease is a leading cause of bacterial meningitis. Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world. Prior to Bexsero, vaccines were available to help protect only against A, C, W-135 and Y.
Bexsero Important Safety Information
Hypersensitivity to the active substances or to any excipients of Bexsero is a contraindication to administration. Administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. Minor infection, such as cold, should not result in the deferral of vaccination.
There are no data on the use of Bexsero in individuals above 50 years of age, in patients with chronic medical conditions or in individuals with impaired immune responsiveness. In immunocompromised individuals, vaccination may not result in a protective antibody response. Insufficient clinical data on exposed pregnancies are available and there are no data on fertility in humans.
Bexsero is not expected to provide protection against all circulating meningococcal group B strains.
The most common adverse reactions observed in clinical trials of infants were tenderness and erythema at the injection site, fever, and irritability. Fever occurred more frequently when Bexsero was co-administered with other routine infant vaccines than when it was given alone.
When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
The safety profiles of the co-administered vaccines were unaffected by concomitant administration of Bexsero with the exception of more frequent occurrence of fever, tenderness at the injection site, change in eating habits and irritability. Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines.
In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
The foregoing release contains forward-looking statements that can be identified by terminology such as "committed," "potentially," "now entering," "will," "expected," "potential," "underway," or similar expressions, or by express or implied discussions regarding the potential outcome of the PBAC's evaluation of Bexsero regarding reimbursement and potential inclusion in the NIP, the potential outcome of similar evaluations in other countries, potential marketing approvals for Bexsero in additional countries, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Bexsero to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Bexsero will ultimately be approved for reimbursement or routine vaccination schedules in Australia or in any other country. Nor can there be any guarantee that Bexsero will be approved for sale in any additional market, or at any particular time. Neither can there be any guarantee that Bexsero will achieve any particular levels of revenue 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; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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 131,000 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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 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 August 7, 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 August 7, 2013.
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 Australian Meningococcal Surveillance Program Annual Report 2011. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-pubs-annlrpt-menganrep.htm. Accessed August 7, 2013.
 Bexsero Prescribing Information.
 Novartis Bexsero EU Approval Press Release. Available at: http://www.novartis.com/newsroom/media-releases/en/2013/1672036.shtml. Accessed August 7, 2013.
 Rosenstein, NE. et al. Meningococcal disease. N Engl J Med. 2001. 344:1378-1388. Available at: http://www.nejm.org/doi/full/10.1056/NEJM200105033441807. Accessed August 7, 2013.
 Wright, Claire et al. Counting the Cost of Meningitis: A severe case of bacterial meningitis. Meningitis Research Foundation. 2011. Available at: http://www.meningitis.org/assets/x/53379. Accessed August 7, 2013.
 Pharmaceutical Benefits Advisory Committee. Available at: http://www.pbs.gov.au/info/industry/listing/elements/pbac-guidelines/a-part-1/section-1. Accessed August 7, 2013.
 Australian Government Department of Health. Immunisation Advisory Bodies. Available at: http://www.health.gov.au/internet/immunise/publishing.nsf/Content/advisory-bodies. Accessed August 7, 2013.
 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 August 7, 2013.
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