Novartis' Rasilez to Carry Warning

Novartis (NVS - Snapshot Report) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended including a warning in the label of hypertension medicine Rasilez in the European Union (EU). Rasilez is marketed as Tekturna in the US.

In December 2011 Novartis had stopped the ALTITUDE study which was investigating Tekturna/Rasilez in a high-risk population of patients with type-II diabetes and renal impairment following recommendation from a Data Monitoring Committee.

Following discussions between CHMP and Novartis, the former recommended that the label of Rasilez and its combination products be updated to include contradictions in using Rasilez in combination with other hypertension medicines known as angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in patients with diabetes or moderate-to-severe renal impairment.

The CHMP has also requested that a warning be included to recommend against using Rasilez and its combination products in patients who are already taking an ACE inhibitor or an ARB. Novartis has begun work to revise the EU label accordingly.

Following termination of the ALTITUDE study in December 2011, Novartis recommended against use of Rasilez/Tekturna-based products in combination with an ACE inhibitor or ARB in hypertensive patients with diabetes. It ceased promotion of any such combination medicines.

The recommendation holds good in all countries outside EU as Novartis continues to interact with health authorities to resolve the issue and determine its implications. In 2012, Novartis has forecast Tekturna/Rasilez sales to be reduced to half of what they were in 2011.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #4 Rank (“Sell” rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, we prefer to remain on the sidelines in the long term due to the imminent patent cliff faced by the company.

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