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Business Update
Speedel, Phase I and II developer of hypertension drug, announces Novartis NDA accepted
May 18th, 2006
Speedel reports achieving a major milestone as Novartis announced the first regulatory submission of SPP100 (aliskiren, Rasilez). The U.S. Food and Drug Administration (FDA) has accepted for review Novartis' new drug application (NDA) for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives. The NDA includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials. SPP100 is the first-in-class once-daily oral renin inhibitor that Speedel successfully developed through Phase I and II clinical trials before Novartis exercised its license-back option in 2002. Novartis...
Source: Biotech Business Week (2006-05-18)
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