Speedel confirms efficacy of SPP100 in 7,000 hypertensive patients

By Elaine Rigoli

Tampa, Fla., Sept. 5 - Speedel Pharmaceuticals, Inc. released new pooled analysis of positive phase 2/3 data on SPP100 (Rasilez) in the treatment of hypertension both as monotherapy and in co-administration with other anti-hypertensives.

The company noted that this is the first analysis in which the efficacy and safety of SPP100 in more than 7,000 patients have been assessed, reconfirming that SPP100 provides consistent blood-pressure lowering with placebo-like tolerability in a broad range of patients with mild-to-moderate hypertension.

The Basel, Switzerland, biopharmaceutical company said this data show how SPP100 is an effective anti-hypertensive independent of age, race and gender.

SPP100 is the first-in-class once-daily orally active renin inhibitor that Speedel successfully developed through phase 1 and 2 clinical trials before Novartis exercised its license-back option in 2002.

The Food and Drug Administration in April accepted for review Novartis' New Drug Application for SPP100 as a treatment for hypertension both as monotherapy and in co-administration.

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