Nov. 5, 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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* Approval marks an important milestone in the process of replacing
50 year-old egg-based flu vaccine production with modern
biotechnology
* Clinical trials in more than 1,850 individuals across all age
groups show strong efficacy, that can induce immune responses
associated with protection against influenza in individuals from
3 to 50 years of age
* Novartis (NYSE:NVS) continues to pursue registration of Celtura in other
major countries
Basel, November 5, 2009 - Novartis announced today that it received
approval from the German regulatory authorities for its adjuvanted
cell culture-based Influenza A(H1N1) 2009 monovalent vaccine,
Celtura®. Novartis continues to pursue registration in other major
countries, including Japan and Switzerland.
Celtura is manufactured in Marburg, Germany and is an MF59®
adjuvanted inactivated influenza virus vaccine indicated for active
immunization of persons six months of age and older against influenza
disease caused by the novel pandemic A(H1N1) influenza virus. The
vaccine contains 3.75 micrograms (ug) of antigen and 0.125 ml of
MF59®. It will be offered in multi-dose vials and in single-dose
pre-filled syringes.
Clinical studies conducted with more than 1,850 subjects evaluated
Celtura's tolerability and immunogenicity. The studies showed that
even with the lowest antigen content (3.75 ug) a single Celtura dose
can induce immune responses associated with protection against
influenza in individuals from 3 to 50 years of age. Safety and
tolerability profiles were as expected. Local injection site
(redness, swelling and pain) and systemic complaints of mild fever,
headache and fatigue were the most frequent side effects reported.
Celtura uses a validated cell culture line for production of viral
antigen components rather than traditional chicken eggs. The
technology has previously been licensed in Europe for the production
of the seasonal flu vaccine, Optaflu®.
"Our modern cell culture technology can enable a faster start-up of
vaccine manufacturing, offering the ability to respond more quickly
to future pandemic threats", said Andrin Oswald, CEO of Novartis
Vaccines and Diagnostics. "We quickly ramped up capacity at our
licensed cell culture facility in Marburg, Germany to respond to the
need for a pandemic vaccine.
