Novartis: Rasilez Controls Blood Pressure Longer-Term

Swiss pharmaceutical company Novartis AG (NVS) Sunday said its experimental blood- pressure lowering drug Rasilez was shown to be safe and effective in a study that followed patients for one year.

Novartis, based in Basel, Switzerland, said the study also showed the ability of Rasilez, or aliskiren, to maintain its blood-pressure lowering effect for more than 24 hours when taken alone or in combination with a diuretic, an older and generically available type of drug.

Sustained 24-hour control can reduce the risk of heart attacks and strokes, Novartis said. Many existing drugs fail to control blood pressure in a sustainable way over 24 hours, with pressure often rebounding in the early morning hours. In efforts to overcome this shortfall, physicians often prescribe that a day's treatment must be taken in two doses.

"The main finding was that the medicine is safe and without side effect for at least a year," Domenic Sica, lead investigator on the study, told Dow Jones Newswires. Sica is Professor of Medicine and Pharmacology at the Medical College of Virginia Commonwealth University in Richmond, Virginia.

The "virtual absence," of side effects like lethargy or fatigue, which are common with older hypertension drugs, is positive because people often end up taking these pills for life, he said.

Novartis completed the U.S. filing of Rasilez in April and plans to submit the drug for approval in Europe at the end of 2006. Rasilez was developed in collaboration with smaller Swiss peer Speedel Holding AG (SPPN.EB), which will get a share of the revenue once the drug has received regulatory approval. The drug has the potential to generate annual sales of at least $1 billion.

If approved, Rasilez could be the first in a new class of blood-pressure lowering medicines, called renin inhibitors. Novartis and competitors drug pipelines at Drug Pipeline Database

Novartis already has several heart drugs in its portfolio, including its best-selling drug Diovan, which also treats high blood pressure and had sales of $3.68 billion in 2005.