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Next generation hypertension drug ready for 2006 filing

Published on 20/01/06 at 11:00am

Next generation hypertension drug aliskiren is on track for filing in late 2006 and is showing promising results in the latest trials, according to its developers.

Aliskeren - to be known under the brand name of Rasilez - is tipped as the first in a next generation of hypertension drugs, with analysts predicting peak sales of around $2.5 billion.

The drug is the first to work by directly inhibiting renin, the key enzyme at the top of the Renin Angiotensin System (RAS), one of the most important regulators of blood pressure.

Novartis is developing the drug with biotech company Speedel and has released new phase III data of the drug in three separate arms of the trial: in combination with an ACE inhibitor (ramipril), a calcium channel blocker (amlodipine) and as a long-term monotherapy.

All three arms of the trial produced encouraging safety and efficacy data, and Speedel's chief executive Dr Alice Huxley said the drug offered numerous benefits over current therapies, including superior reduction in blood pressure particularly in combination with existing treatments and improved protection of end-organs such as the heart and kidneys.

The drug's apparent ability to produce 24-hour blood pressure control - particularly in the early morning when blood pressure can surge in patients - could be another key claim over existing treatments.

Dr Huxley said: "We are delighted with the latest data from Novartis reconfirming SPP100 as a potential gold standard, first-in-class therapy for treating hypertension. The clinical data generated so far by both Novartis and Speedel shows the potential benefits of co-administration of SPP100 with the four most common classes of blood pressure modulators."

Novartis has confirmed that Rasilez is on track for submission in the US in early 2006 and in the EU in the fourth quarter of 2006.

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Thursday , September 22, 2005

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