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UK children remain unnecessarily at risk for life-threatening and disabling meningitis B disease, following JCVI interim recommendation on Novartis Bexsero® vaccine


July 24, 2013 - London

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 . Processed and transmitted by Thomson Reuters ONE.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 @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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