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Italy Lifts Ban on Novartis Vaccines

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Swiss pharmaceutical giant Novartis (NVS) 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 month.

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. (REGN).

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (“Hold” rating) in the short run.

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