Novartis blood pressure pill shows 1-year benefits

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.