Patent expiry of Diovan, a market-leading hypertension medication, is expected in the United States in September 2012, but plans to restructure were accelerated after the ALTITUDE study was halted following the recommendation from the Data Monitoring Committee overseeing that trial, which was investigating Rasilez/Tekturna in a high-risk population of patients with type 2 diabetes and renal impairment. As a precautionary measure, Novartis ceased all promotion of Rasilez/Tekturna-based products for use in combination with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis, in consultation with health authorities, is now recommending that hypertensive patients with diabetes should not be treated with Rasilez/Tekturna in combination with an ACE-inhibitor or ARB.

 

"Patient safety is the highest priority for Novartis and we are in continuing dialogue with health authorities worldwide to establish the most appropriate next steps," the company noted in its announcement of the restructuring.   

 

A reassessment of the future sales potential of Rasilez/Tekturna in light of the ALTITUDE results has led to an exceptional charge of approximately $900 million (of which approximately $800 million is non-cash) to be recognized in the fourth quarter of 2011. The charge comprises impairments to intangible and manufacturing assets and excess inventory together with trial wind-down and other exit costs. The accounting charge is triggered by lower sales expectations and does not seek to anticipate the results of our ongoing discussions with health authorities concerning Rasilez/Tekturna.