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Novartis presents series of novel vaccines
Cambridge | Thursday, June 5, 2008, 08:00 Hrs  [IST]

Novartis unveiled a promising pipeline of novel vaccines, highlighting vaccine candidates that address significant unmet needs for prevention of fatal diseases such as meningococcal infections and other hospital and community acquired infections. Several vaccine candidates from the Novartis Vaccines research and development portfolio have the potential of being first of its kind.

"Our emerging late and early stage pipeline underscores our commitment to prevention as a means to improve health and address public health challenges," said Dr Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics. "We are focusing on diseases such as meningococcal meningitis where current vaccines do not protect against all strains that cause this potentially fatal condition which affects up to 500,000 people a year".

Novartis has two meningococcal vaccines in late stage development, Menveo (ACWY-CRM conjugate vaccine) for infants and adolescents and MenB for multiple strains of the meningococcal serogroup B.

Novartis is the only company currently developing vaccines against all five meningococcal serogroups (A, B, C, W-135 and Y) in phase III clinical trials, a Novartis press release said.

Currently, available vaccines do not provide adequate protection against all meningococcal disease serogroups, particularly in young children and adolescents who have the highest rate of disease. The disease is estimated to strike an estimated 500,000 people annually of whom an estimated 50,000 die and up to 20 per cent suffer from serious long-term consequences such as deafness, neurological damage or limb loss.

"Meningococcal meningitis is a potentially vaccine-preventable disease and with new vaccines offering protection across age groups, other families may not have to suffer losing a child as I did to this devastating, yet preventable illness," said Lynn Bozof, executive director and one of the five founding members of The National Meningitis Association".

Recent phase III trial data for Menveo (MenACWY-CRM) suggest that it has the potential to become the first meningococcal vaccine to protect all age groups from infancy to adulthood against the four vaccine preventable serogroups (A, C, W-135 and Y). A pivotal phase III study compared Menveo head to head with Menactra. The co-primary objectives were lot-to-lot consistency for three Menveo lots and seroresponse non-inferiority of Menveo as compared with Menactra for the 11 to 18 and 19 to 55 years of age groups, followed by a pre-defined superiority analysis after non-inferiority was first demonstrated. Submissions for infants and young children 2 months-10 years of age are planned for 2009. Menveo is expected to fit within standard childhood vaccination schedules.

The Novartis MenB vaccine is a recombinant vaccine that is designed to protect against a majority of global strains of serogroup B for which no vaccine is currently available. In Europe, North America and many other parts of the world the B strain is the most common meningococcal serogroup. In clinical trials completed to date, the Novartis MenB vaccine has shown excellent immunogenicity in infants and strong immunogenicity in adults in early clinical development. A phase III trial in infants and children is currently ongoing as part of a comprehensive phase III development effort for the vaccine. Regulatory submissions for the Novartis MenB vaccine for infants and children are planned for 2010.

Novartis has a strong position in prevention of meningococcal disease achieved via the distribution of more than 26 million doses of Menjugate (MenC-CRM) and the production of MeNZB against a strain of meningococcus B specific to an outbreak in New Zealand.

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