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Novartis blood pressure pill shows 1-year benefits

Posted on: Sunday, 3 September 2006, 01:34 CDT

By Ben Hirschler

BARCELONA (Reuters) - Rasilez, the first of a new class of hypertension drugs developed by Novartis, produces a consistent and sustained reduction in blood pressure over a full year of treatment, researchers said on Sunday.

The long-term benefits were seen whether the drug was given on its own or in combination with hydrochlorothiazide, an older diuretic drug, according to clinical trial results presented at the World Congress of Cardiology.

Novartis filed in April for U.S. marketing approval of Rasilez, which industry analysts believe could have sales of more than $1 billion a year.

The Swiss group will seek European approval before the end 2006.

Researchers also found there was no risk of a rebound in blood pressure if patients stopped taking Rasilez after 11 months -- a potentially important benefit in managing health.

Professor Domenic Sica of Virginia Commonwealth University in Richmond, Virginia, said the lack of rebound might be because Rasilez, or aliskiren, is the first drug to directly inhibit the body's renin system, which is central to blood pressure control.

"Normally we'd expect blood pressure to quickly return to pre-treatment levels when a medicine is stopped. However, our study showed that this does not occur with aliskiren," he said.

The results showed Rasilez on its own cut mean systolic and diastolic blood pressure levels by 17.4 and 13.3 millimeters of mercury (mmHg) over one year, while the reduction was 18.7 and 12.1 mmHg in combination with hydrochlorothiazide.

Importantly, Rasilez showed round-the-clock control of blood pressure, even after a year of treatment. Many existing blood pressure medicines do not provide full 24-hour control, which can increase the risk of heart and strokes.

BEYOND DIOVAN

Analysts believe 24-hour control is a potentially important selling point for Rasilez, along with the fact it may protect the patient's organs from blood pressure-related damage.

Rasilez, which was developed by Swiss biotech company Speedel, is a key new product for Novartis, which is seeking ways to shore up its hypertension medicine sales.

This business is currently supported by Diovan, Novartis' top-seller with 2005 sales of $3.7 billion. But Diovan will lose patent protection in 2012.

Novartis had hoped Rasilez would produce synergies when added to Diovan but initial trials have proved disappointing.

Getting multiple blood pressure drugs to work together is important, since many patients do not respond adequately to a single medicine.

A smaller six-week study presented in Barcelona found that adding Rasilez to amlodipine -- a so-called calcium channel blocker drug sold as Norvasc by Pfizer Inc -- also provided additional blood pressure reductions.

Norvasc will lose patent protection in 2007.

Ameet Nathwani, global head of cardiovascular and metabolic clinical R&D at Novartis, told Reuters he saw great potential in such Rasilez-based combinations.

"Both the hydrochlorothiazide and amlodipine combinations have produced good data, which would imply we could develop both," he said.

Source: REUTERS

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