Novartis’ new antihypertensive medication Rasilez was more effective than the ACE inhibitor ramipril in treating diabetics who also have high blood pressure, a group with a particularly high risk of developing heart disease.
The new data on Rasilez (aliskiren), the first in a new class of renin inhibitor drugs, were particularly impressive because the trial had been designed to show non-inferiority to ramipril, with an additional effect on blood pressure expected only for a combined treatment group receiving both drugs.
In fact, both Rasilez and Rasilez/ramipril performed better than the ACE inhibitor on its own, and by the end of the study significantly more patients in the first two groups had reached their blood pressure targets.
Diabetics with hypertension have two to four times the risk of going on to develop full-blown heart disease, so their target blood pressure targets are set lower than for patients with hypertension alone.
For this reason, most patients require treatment with more than one drug. Until now no agent had been shown to improve blood pressure control over the ACE inhibitors in diabetics – even the newer angiotensin II receptor antagonists such as Novartis’ own Diovan (valsartan) - so the new data suggest that Rasilez could quickly be positioned as the primary drug of choice in these patients.
This should increase the chances that the renin inhibitor will achieve its predicted billion dollar-plus sales potential and, with other drugs in this class thought to be at least five years behind in development, should give Novartis a lucrative franchise over the coming years. Rasilez has been submitted for approval in the USA and a submission in Europe is expected later this year.
Denise Anderson, an analyst at Zurich-based Kepler Equities, has said she expects sales from Novartis' portfolio of antihypertensives to rise to $7.7 billion by 2009 from $4.8 billion in 2005. Diovan sales were $3.7 billion last year.
Meanwhile, Novartis has continued its run of product licensing deals by securing rights to a vaccine against Japanese encephalitis, developed by Austrian company Intercell, adding to its stable of vaccine products brought in-house via its purchase of Chiron.
Novartis will pay Intercell up to 37 million euros in milestone payments for rights to the vaccine, which is in Phase III testing, and will make an equity investment in the Austrian company of up to 30 million euros.
With over 3 billion people living in endemic areas, Japanese encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia. UK company Acambis is developing a rival product called Chimerivax-JE, which entered Phase III testing last November.