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Novartis hopes of blockbuster status for Rasilez dashed

Promotion of aliskiren products in combination with an ACE inhibitor or ARB to cease after adverse events cause trial in high risk patients to end

Novartis has abandoned a trial of its renin inhibitor Rasilez/Tekturna in high-risk patients with diabetes and renal impairment after seeing higher rates of adverse events in patients receiving the drug.

The ALTITUDE study was intended to position Rasilez (aliskiren) as an add-on to treatment with ACE inhibitors or angiotensin II receptor blockers (ARBs) in diabetics with renal impairment, which could have opened up a huge new market for the drug.

The results showed however that adding Rasilez to ACE inhibitor or ARB therapy increased the rate of non-fatal stroke, renal complications, high blood pressure and elevated blood potassium levels after 18-24 months' treatment.

Moreover, Novartis is also recommending that doctors do not prescribe drugs containing aliskiren alongside ACE inhibitors or ARBs, and suggests patients who are already doing so should be switched to alternative treatment.

"Novartis is in ongoing discussions with health authorities worldwide about the implications of the findings from ALTITUDE for patients," said the company in a statement.

"As a precautionary measure, Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE inhibitor or ARB." The company also sells a fixed-dose combination of the drug with its own ARB valsartan under the Valturna brand.

Novartis had high hopes for Rasilez when it was launched in 2007, and sales have been growing steadily, reaching almost $450m in the first nine months of this year. However, the vast majority of patients taking the drug will also be on ACE inhibitors or ARBs, so the fall-out from ALTITUDE is likely to be significant.

The results are also unexpected given that an earlier trials of aliskiren - AVOID - seemed to suggest that a dual strategy targeting both renin and angiotensin systems could prevent the renal damage seen in hypertensive patients.

Novartis said sales are likely to take a hit on the back of the study results, and indicated that the product remained unprofitable in 2011. Analysts have suggested that the company could make sweeping cuts to its salesforce as a result of the disappointment.

21st December 2011

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