Swiss pharmaceutical giant
) recently announced that the Italian Medicines Agency (AIFA) has
lifted the temporary halt on Novartis' seasonal influenza
vaccines Agrippal and Fluad.
The decision from the Italian regulatory authority was based
on additional information provided by the company and AIFA's
independent assessment which reaffirmed the safety and efficacy
of Agrippal and Fluad. To date, over one million doses were
administered without any adverse events being reported in the
2012-2013 influenza season.
Novartis had reported a higher than usual level of protein
aggregates in one of the batches of Agrippal and Fluad. The
Italian regulatory authorities banned the use of Novartis'
seasonal influenza vaccines on October 24, 2012. Similar
decisions were taken in other countries as well.
We remind investors that Italy is the regulatory reference
country for these vaccines within the European Union (EU).
Novartis intends to work with other countries in the EU so that
it can lift the lingering precautionary measures and begin supply
thereafter. We expect Novartis will be able to solve the issue
agreeably in other countries soon. Agrippal and Fluad are
currently not available in the US.
In October this year, Health Canada and the Swiss Agency for
Therapeutic Products, Swissmedic lifted the halt on these
vaccines. The halt was also lifted in Singapore earlier this
Meanwhile, Novartis announced new data from its phase II
trials on ACZ885 (canakinumab). ACZ885 is being developed to
treat patients suffering from one of two rare syndromes
characterized by periodic fevers, familial Mediterranean fever
(FMF) and tumor necrosis factor (TNF) receptor-associated
periodic syndrome (TRAPS).
Data from the study revealed that ACZ885 reduces disease
attack frequency and normalizes inflammation markers in patients
suffering from FMF, sustains relief from symptoms in patients
suffering from TNF receptor, normalizes blood markers of
inflammation and improves quality of life.
We note that ACZ885 is already approved as Ilaris for the
treatment of cryopyrin-associated periodic syndromes (CAPS). We
note that the CAPS market currently has players like
Regeneron Pharmaceuticals, Inc.
Currently, we have a Neutral recommendation on Novartis. The
company carries a Zacks #3 Rank ("Hold" rating) in the short
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