Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated

Novartis International AG /
Novartis announces Aliskiren will continue to be available to appropriate
patients, as FDA interim assessment is concluded; product information updated
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* Combination product Valturna® to be voluntarily withdrawn from the US market
as of July 20, 2012

Basel, Switzerland April 19, 2012 - Novartis announced today that the
Tekturna(®) labels have been updated in the US, following the US Food and Drug
Administration´s (FDA) review of the preliminary findings from the ALTITUDE
study.

The label change includes a contraindication against combined use of aliskiren-
based products with angiotensin converting enzyme (ACE) inhibitors or
angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also
requested the inclusion of a warning against the use of aliskiren-based products
in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are
also taking an ACE inhibitor or an ARB. Aliskiren-based products will continue
to be available in the US for the treatment of high blood pressure in
appropriate patients.

Furthermore, and in consultation with the FDA, Novartis has decided to
voluntarily cease marketing in the US of Valturna(®) (aliskiren and valsartan,
USP), a single pill combination of aliskiren and the ARB valsartan. Valturna
sales in the US represented less than 10% of Aliskiren sales in 2011. Novartis
advises US patients to seek guidance from their prescribing healthcare provider
at their next (non-urgent) visit to determine appropriate alternate therapy.
Novartis has also decided to voluntarily withdraw marketing authorization of the
same combination pill in Switzerland, Rasival(® )(aliskiren and valsartan),
which received marketing approval for export but was not launched.

"These decisions come after extensive discussions with the FDA and Swissmedic, "
said David Epstein, Division Head of Novartis Pharmaceuticals. "Patient safety
continues to be our highest priority and we will continue to work with health
authorities worldwide to provide aliskiren-based products to the most
appropriate patient population who would benefit."

These updates follow the Novartis announcement on February 17, 2012 that the
European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use
(CHMP) concluded the risk-benefit review of Rasilez and combination products
containing aliskiren and confirmed it remains positive in the European Union
(EU) for the treatment of essential hypertension, with label changes.