UK children remain unnecessarily at risk for life-threatening and disabling meningitis B disease, following JCVI interim recommendation on Novartis Bexsero® vaccine
(Thomson Reuters ONE) -
Novartis International AG /
UK children remain unnecessarily at risk for life-threatening and disabling
meningitis B disease, following JCVI interim recommendation on Novartis Bexsero®
vaccine
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The issuer is solely responsible for the content of this announcement.
* JCVI takes interim position to not recommend Bexsero for the routine
immunization program, driven by evaluation based on cost-effectiveness
assumptions[3]
* The evaluation by JCVI was made prior to any pricing discussion with the
Company and underestimates the potentially devastating impact of the disease
* The position, if not changed, will delay Bexsero access and cause
unnecessary death and disability among children and adolescents[1],[2]
Basel, July 24, 2013 - Novartis is disappointed by the interim position of the
UK Joint Committee on Vaccination and Immunisation (JCVI) to not recommend
Bexsero(®) for inclusion in the National Immunisation Programme at this time,
and does not believe that the decision is in the interest of the public. Key
feedback included in the JCVI interim position states that Bexsero is unlikely
to prove cost-effective based on the current method of evaluation in the UK[3].
Novartis was not asked for pricing information as part of the JCVI deliberation
and intends to provide related input prior to the recommendation being
finalized.
"The interim position by the JCVI is inconsistent with its recommendations for
other meningococcal vaccines. The meningitis C vaccination campaign in the UK,
following JCVI recommendation, was a tremendous public health success saving
thousands from serious illness and death," said Andrin Oswald, Division Head,
Novartis Vaccines and Diagnostics. "It is disappointing to see that the decision
was mostly driven by financial considerations and without any pricing discussion
with Novartis. The evaluation model does not do justice to the vaccine's ability
to prevent babies and young children from dying or surviving with severe
lifelong disabilities."
In January 2013, the European Medicines Agency licensed Bexsero for active
immunization of individuals from two months of age and older against invasive
meningococcal disease caused by Neisseria meningitidis group B[4]. Results from
robust Phase III studies have confirmed the Bexsero safety and immunogenicity
profile. Bexsero clinical trials have involved more than 8,000 people receiving
at least one dose of the vaccine[5].
Novartis believes that the current method of evaluating the cost-effectiveness
of Bexsero fails to fully capture the lifetime benefits of disease prevention
and undervalues technologies that prevent diseases. In particular, since 1999, a
similar vaccine for meningococcal serogroup C disease is estimated to have
prevented more than 9,000 cases of serious disease and more than 1,000 deaths in
the UK[6].
In the UK, children continue to die and suffer each year from meningitis B
disease[2]. Until Bexsero is included on the routine immunization schedule,
which provides broad access to vaccines for children, meningitis B will remain a
threat for youth in the UK causing needless death and disability[1],[2].
Bacterial meningitis and septicemia kill more children under five than any other
infectious disease in the UK[7].
The repercussions of meningitis B disease for patients and families affected as
well as national healthcare systems are significant[8]. Bexsero is the only
broad coverage vaccine against this often devastating disease, which can kill
within 24 hours or cause serious, life-long disabilities[1],[4]. Prevention
through vaccination is therefore the only defense against an aggressive disease
that leaves little time for intervention[4].
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.
Bexsero should not be given to individuals with thrombocytopenia or any
coagulation disorder that would contraindicate intramuscular injection, unless
the potential benefit clearly outweighs the risk of administration. Appropriate
medical treatment and supervision should always be readily available in case of
an anaphylactic event following administration of Bexsero.
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.
Higher rates of antipyretic use were also reported for infants vaccinated with
Bexsero and routine vaccines. 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.
Due to an increased risk of fever, tenderness at the injection site, change in
eating habits and irritability when Bexsero was co-administered with routine
vaccines, separate vaccinations can be considered when possible.
In adolescents and adults the most common local and systemic adverse reactions
observed were pain at the injection site, malaise and headache.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommendation," "recommend," "will," "intends,"
"potential," "expected," or similar expressions, or by express or implied
discussions regarding the potential outcome of the JCVI's evaluation, the
potential outcome of similar evaluations in other 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 be ultimately be approved for routine vaccination schedules in the UK or in
any other market. Nor 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; competition in
general; government, industry and general public pricing pressures; unexpected
manufacturing issues; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; 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.
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 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.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
1. World Health Organization. Meningococcal meningitis. Fact sheet #141.
November 2012. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed on July 2013.
2. European Centre for Disease Prevention and Control. Annual Epidemiological
Report: Reporting on 2010 Surveillance Data and 2011 Epidemic Intelligence
Data. 2012 Available at:
http://ecdc.europa.eu/en/publications/Publications/Annual-Epidemiological-
Report-2012.pdf. Accessed on July 2013.
3. JCVI Minutes for Meeting: June, 2013.
4. Novartis Bexsero EU Approval Press Release. Available at:
http://www.novartis.com/newsroom/media-releases/en/2013/1672036.shtml.
Accessed July 2013.
5. Novartis Data on File.
6. UK Health Protection Agency. Vaccination for Meningococcal Disease.
Available at
http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1296682977081?pri.
Accessed July 2013.
7. Office for National Statistics. Mortality statistics: Deaths registered in
2010 (Series DR) Table 5.1 Available at: http://bit.ly/uHcnTt. Accessed July
2013.
8. 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 July 2013.
# # #
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