( RAS) one of the key regulators of bloo...)New Data Highlights Potential of SPP100 (Tekturna) as Gold Standard,Therapy in Treatment of Hypertension,Health

RAS), one of the key regulators of blood pressure. The RAS is a cascade, starting with renin, leading to angiotensin I and finally to angiotensin II. Angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor antagonists (ARBs) have been developed to block this system "down stream" and have shown clinical efficacy in patients with hypertension and other cardiovascular diseases. By inhibiting renin at the top of the RAS, SPP100 decreases the system's activity, as measured by Plasma Renin Activity. PRA is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is an independent and direct surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. Renin inhibitors lower PRA whereas most current leading anti-hypertensive drug classes such as ACE-Is and ARBs increase PRA levels.

Speedel in-licensed SPP100 from Novartis in 1999 and successfully completed 18 clinical trials, through Phase I and II in about 500 patients and healthy volunteers. Based on the results generated during this programme, Novartis exercised a license-back option in 2002, and Novartis subsequently started trials with SPP100 in Phase III as monotherapy for hypertension and in Phase IIb as combination therapy. Regulatory approval was given by the US FDA in March 2007 and a regulatory submission was made by Novartis in the EU during Q3 2006. Speedel believes that it is the first company to establish successfully a clinical proof of concept in Phase II and to have developed and filed for patent protection a commercially viable manufacturing process for a renin inhibitor, an area of industry research for over 20 years. In a Phase II study of 200 patients conducted by Speedel, it was demonstrated that Tekturna achieves dose-dependent blood pressure reduction. The study also showed that 150mg and 300mg SPP100 once daily were comparable to Losartan 100mg, which is double the usual starting dose of this ARB
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