Speedel (SWX: SPPN) today welcomed the significant new results from clinical trials of SPP100 (aliskiren, Tekturna/Rasliez[1]) presented by investigators at the 22nd Annual Scientific Meeting and Exposition of the American Society of Hypertension (ASH) in Chicago, IL, USA. These results confirm the favourable safety and efficacy profile, as well as the potential advantages of this first-in-class once daily direct renin inhibitor for the treatment of hypertension. Tekturna was approved by the US Food and Drug Administration (FDA) and launched by Novartis in the US in March 2007 to treat hypertension both as monotherapy and in combination with other anti-hypertensives. In September 2006, SPP100 was also submitted by Novartis to the European Medicines Agency (EMEA) for review in the European Union. Speedel successfully developed SPP100 through Phase I and II clinical trials before Novartis exercised its license-back option in 2002.
