Novartis gets FDA approval for heart attack treatment; acquires rights to develop new dialysis treatment.


Novartis AG, Basel, Switzerland, announced the US Food and Drug Administration (FDA) has approved Diovan, the most prescribed angiotensin receptor blocker (ARB) worldwide, for a new indication to reduce cardiovascular death in patients with high risk (with left ventricular failure or left ventricular dysfunction) following a heart attack. The FDA also expanded the drug's heart failure labeling. Novartis says as a result of the action Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.

Diovan is now the only agent in its class across the world indicated to treat high blood pressure, high risk heart attack survivors and people with heart failure. Novartis says the US approval came shortly after marketing authorizations were granted for the drug in 14 European Union (EU) member states and other countries around the world to treat people who survived a recent heart attack and people with heart failure.

Novartis also announced it has signed an agreement with SeBo GmbH of Germany to acquire the global rights for a novel oral phosphate binder in development for the treatment of elevated serum phosphate levels (hyperphosphatemia) in late- or end-stage renal disease patients.

Under terms of the agreement, which were not disclosed, the company has obtained the rights to develop, manufacture and commercialize the compound for patients with chronic kidney disease or patients already on dialysis. The compound is currently in Phase 1 clinical development.

Novartis notes at least 90% of dialysis patients receive chronic treatment for hyperphoshatemia, which an estimated 80% of patients with chronic kidney disease are also treated for the condition.

Contact: Eric Althoff - +44 (61) 324 6392, or John Gilardi - +41 (61) 324 3018, Web site: www.novartis.com

COPYRIGHT 2005 Transplant Communications, Inc. Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.

Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

NOTE: All illustrations and photos have been removed from this article.


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