Novartis meningococcal vaccine Menveo® recommended for approval in the European Union for prevention of disease in adolescents and adults

Basel - Novartis
(Meningococcal Group A, C, W-135 and Y-CRM Conjugate Vaccine) has received a Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The investigational conjugate vaccine is recommended for Menveo is designed to help protect against four of the five major groups of meningococcal bacteria, which are leading causes of bacterial meningitis – an infection of the membrane around the brain and spinal cord – and sepsis – a bloodstream infection[1a], [2] The CHMP recommendation serves as the basis for a European Commission licensing Decision. The CHMP is recommending that the European Commission grant Marketing Authorization for Menveo in all 27 European Union (EU) countries, which is expected during the first quarter of 2010. Regulatory review for Menveo by the US Food and Drug Administration is ongoing. Upon licensure, Menveo is expected to be the first conjugate vaccine to be commercially available in Europe to help protect against four major groups of meningococcal bacteria.  Meningococcal disease is a sudden, “The CommitteeÂ’s positive recommendation of Menveo is a significant advance in the fight against meningococcal disease,” said Professor Ray Borrow who heads the Health Protection AgencyÂ’s Vaccine Evaluation Unit in the UK. “Five groups of meningococcal bacteria cause the majority of meningococcal disease cases around the world[3b] . Since it is impossible to predict which meningococcal bacterial group one might come into contact with, a vaccine that offers effective protection against four of the groups should be extremely effective in preventing and controlling the disease. It is a welcome development.” “This is an important milestone toward our vision to eradicate this devastating, deadly and unpredictable disease,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. “We are confident that broad coverage with Menveo will eventually be available to all age groups.” When utilized in a national immunization program, conjugate vaccines (such as those designed to help protect against Hib, pneumococcal and meningococcal group C disease) have reduced the number of people (both vaccinated and unvaccinated) who carry the bacteria that cause the disease.  In addition, adolescents and young adults have relatively high death rates from meningococcal infection. A study in the United States found that nearly a quarter of meningococcal infections in 15- through 24-year-olds were fatal[8]. it can be difficult for health care professionals to diagnose early. Classic symptoms, such as neck stiffness and petechial rash, do not appear until relatively late in the illness – 13-22 hours after the first symptoms appear[11]. , a meningococcal serogroup C conjugate vaccine approved outside the U.S. since 2000 for use in individuals from 2 months of age through adulthood. The company has already distributed more than 26 million doses of Menjugate around the world.  Novartis also produced MenZB Novartis Vaccines is a global leader in providing vaccines to protect against deadly meningococcal disease. Through industry-leading scientific expertise, the company is focused on extending critical meningococcal vaccines research.  In addition to developing Menveo vaccine, Novartis Vaccines is developing a recombinant protein recommendation,” “recommended,” “risk,” “should,” “recommending,” “expected,” “can,” “will,” “confident,” “anticipates,” “potential,” or similar expressions, or by express or implied discussions regarding potential approvals to market for Menveo or other vaccines, or regarding potential future revenues from Menveo or such other vaccines. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Menveo or any other vaccine referred to in this release will be approved for sale in any market. Nor can there be any guarantee that such products will achieve any particular levels of revenue in the future. In particular, managementÂ’s expectations 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 companyÂ’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures , and other risks and factors referred to in Novartis AGÂ’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 Vaccines and Diagnostics is a division of Novartis focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the world’s fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division’s products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world’s blood supply. Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the GroupÂ’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, Schaffner, W. et al. The Changing Epidemiology of Meningococcal Disease Among US Children, Adolescents, and Young Adults. National Foundation for Infectious Diseases. November 2004. Available at: .  Accessed on World Health Organization. Meningococcal Position Paper. Weekly Epidemiological Record No. 44, 2002, 77, 329-340. Available at: . Accessed on November 17, 2009. Centers for Disease Control and Prevention.  Prevention and Control of Meningococcal Disease – Recommendations of the Advisory Committee on Immunization Practices. MMWR 2005; 54 (RR07): 1-21. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm. Accessed on November 17, 2009. Centers for Disease Control and Prevention. Travel-Related Vaccine-Preventable Diseases: Meningococcal Disease (Health Information for International Travel: The Yellow Book). 2010 Online Edition. Available at: . Accessed on November 17, 2009.

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