Jun. 30, 2009 (Hugin AS) -- Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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Cambridge, MA, June 30, 2009 - Novartis (NYSE:NVS) Vaccines and Diagnostics
received feedback from the US Food and Drug Administration (FDA) in
the form of an initial regulatory determination on the Biologics
License Application (BLA) for the investigational vaccine Menveo®.
The FDA has requested additional information on the clinical and the
CMC (Chemistry Manufacturing and Control) sections of the BLA. No new
clinical trials are required, and it is expected that Novartis will
be able to respond to all questions fully in 2009. The BLA was
submitted on August 28, 2008 for use of Menveo in subjects age 11 -
55.
In clinical trials, Menveo has been shown to elicit a protective
immune response against four of the most common serogroups - A, C,
W-135 and Y - of Neisseria meningitides, also known as meningococcus.
These serogroups can cause potentially deadly bacterial infections
and account for most cases of meningococcal disease worldwide.
"Meningococcal disease is a devastating illness that can result in
rapid death or have long-lasting repercussions for survivors and
their families," said Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "We are dedicated to applying our industry-leading
technology and expertise to further the development of Menveo and
other vaccines that elicit robust, long-lasting, protective immune
responses for all age groups at risk."
About the Novartis Vaccines global meningococcal franchise
Menveo is based on the same proprietary technology Novartis Vaccines
pioneered to produce Menjugate®, a meningococcal serogroup C
conjugate vaccine approved outside the US since 2000 for use in
individuals from age 2 months through adulthood.
Studies have reported that Menveo generates a robust immune response
against the four vaccine-preventable serogroups, A, C, W-135 and Y in
people across age groups from infancy to adulthood. A Phase II study
in infants published in the January 9, 2008, issue of the Journal of
the American Medical Association reported that Menveo is the first
meningococcal vaccine candidate to elicit a robust immune response in
infants[1]. There is no vaccine currently licensed in the US for use
in infants.
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 Menveo, Novartis
Vaccines is developing a recombinant vaccine for its potential to
provide broad coverage against multiple strains of serogroup B, for
which no vaccine is currently available. The company has already
distributed more than 26 million doses of Menjugate around the world
and produced MenZB®, a vaccine against a strain of meningococcus B
specific to a recent outbreak in New Zealand.
About meningococcal disease, a leading cause of bacterial meningitis
Meningococcal disease can manifest as bacterial meningitis - an
infection of the protective coverings of the brain and spinal cord -
or meningococcemia - a bloodstream infection[2]. It is caused by the
bacterium Neisseria meningitidis (N. meningitidis). The symptoms,
which can include sudden onset of fever, rash, headache and stiff
neck, can progress rapidly.
