Novartis submits Bexsero® for regulatory review in Europe

NovartisNovartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Bexsero® (Multi-Component Meningococcal B Vaccine; formerly known as 4CMenB). Upon approval, Bexsero will be the first broad-coverage vaccine licensed for use against disease caused by meningococcal serogroup B bacteria (MenB) in all European Union (EU) and European Economic Area (EEA) countries[1,2]. Submission is supported by comprehensive clinical and epidemiological data which characterize the safety and immunogenicity profile, and the predicted coverage of Bexsero[3,4,5].

"The Bexsero submission in the EU is an important milestone toward achieving the world's first broad-coverage MenB vaccine through our unique multi-component approach[1,2]," said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. "Meningococcal disease is sudden and aggressive, leaving little time for treatment[6], [7]. Proactive vaccination of individuals has been shown to offer the best protection against fatal infectious diseases. Novartis is committed to providing vaccines to protect people of all ages, including infants, and against all causes, of meningococcal disease."

The tremendous diversity of MenB strains around the world has been one of the main challenges to developing an effective broad-coverage MenB vaccine[13]. The four distinct antigen components of Novartis' Bexsero vaccine were selected because they are important for the bacteria's survival, function or ability to cause infection, and can be found in the majority of MenB strains circulating worldwide[1,14,15]. Data predict that the majority of strains would be covered by more than one of the Bexsero vaccine antigens, preventing disease caused by current MenB strains and by eventual genetic strain shifts[5].

Coverage data have been generated to predict the ability of the vaccine to protect infants vaccinated at 2, 4, 6 and 12 months of age against the disease-causing MenB strains circulating in their local environments[5]. Preliminary data show that Bexsero covers potentially 77 percent (95% confidence limits from 66-91%) of more than 800 genetically diverse disease-causing MenB strains isolated in Europe in recent years[5]. The strong coverage estimates of Bexsero highlight the unique benefits of the multi-component approach. Analysis of additional strains is currently ongoing and expected to be shared in 2011.

Completed clinical trials involved more than 7,500 infants, adolescents and adults. In infants, studies show that Bexsero could be either co-administered with other routine vaccines or as part of a flexible vaccination schedule.

The EU regulatory submission for Bexsero is planned to form the basis for further submissions. Novartis has prioritized future submissions where the potential public health impact is greatest, including countries in Asia, Latin America and North America.

About Bexsero
The Novartis Bexsero vaccine was developed using a pioneering approach known as "reverse vaccinology." In contrast to conventional methods of developing vaccines, reverse vaccinology decodes the genetic makeup (genome sequence) of MenB and selects those proteins that are most likely to be broadly-effective vaccine candidates[16]. Bexsero contains multiple components, which independently are highly immunogenic and, taken together, have the potential to protect against a broad range of disease-causing strains[1,14,15].

About Meningococcal Disease
Invasive meningococcal disease is a sudden, aggressive illness that can lead to death within 24-48 hours of the first symptoms[6,7]. It is a leading cause of bacterial meningitis - an infection of the membrane around the brain and spine[8] - and sepsis - a bloodstream infection[7,12]. Survivors may experience side effects, called sequelae, such as brain damage, learning disabilities, hearing loss, and limb amputations[12].

Licensed vaccines are available to protect against meningococcal disease caused by serogroups A, C, W135 and Y[8]; however, meningococcal disease caused by serogroup B has posed a significant burden to people around the world, especially infants, who are at highest risk for infection[10,11]. Global incidence of MenB infection is estimated to be between 20,000 and 80,000 cases per year, with a 10 percent fatality rate[17]. In Europe, MenB causes up to 80 percent of meningococcal disease cases[9]. MenB strains circulate worldwide, can mutate and may also result in long-term regional outbreaks over and above the ongoing baseline threat. MenB has caused such outbreaks of disease around the world, including in New Zealand, the United Kingdom, and France[1].

About Novartis
Novartis Vaccines and Diagnostics is a division of Novartis, focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Novartis Diagnostics. 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. Novartis Diagnostics, the blood testing 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 these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100, 000 full-time-equivalent associates and operate in more than 140 countries around the world.

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