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news.Swiss drugmaker Novartis has received positive phase III clinical with the experimental hypertension drug SPP100, both as both a monotherapy and in combination with other therapeutics.
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SPP100 (aliskiren), which is expected to launch under the trade name Rasilez, was tested on its own and in co-administration with amlodipine (a calcium channel blocker) and ramipril (an ACE inhibitor). Novartis is on track for first regulatory submission of SPP100 in the US in early 2006 and in the EU in the fourth quarter of 2006.
These submissions will be for SPP100 as a monotherapy, and for co-administration with other anti-hypertensive therapies, based on trials evaluating over 8,000 patients.
SPP100 is the first-in-class once daily oral renin inhibitor being developed for the treatment of hypertension. Speedel in-licensed the compound from Novartis and successfully developed it through phase I and II before Novartis exercised a license-back option in 2002.
“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. Hypertension is one of the largest and growing unmet medical needs across the world,” said Dr Alice Huxley, CEO of Speedel.
“SPP100 potentially offers benefits over current therapies, particularly for improved protection of end-organs such as the heart and kidneys,” Dr Huxley continued.