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news.BioMarin Pharmaceutical has said that its investigational hypertension drug 6R-BH4 failed to cause a statistically meaningful drop in systolic blood pressure relative to placebo.
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The eight-week multi-center, randomized, double-blind, placebo-controlled study enrolled 116 patients with poorly controlled systemic hypertension, approximately half with type 2 diabetes. Patients receiving placebo experienced a 6.4 mm Hg drop in systolic blood pressure compared to a drop of 4.8 mm Hg for patients receiving 6R-BH4. The difference was not statistically significant, said BioMarin.
The compound 6R-BH4 is the active ingredient in Phenoptin, a treatment for the genetic disorder PKU. BioMarin has received fast-track status for the drug from the FDA and is expected to gain approval in late 2007. Datamonitor forecasts sales to reach $161 million in 2008.
CEO Jean-Jacques Bienaime said: “We remain on track to file our new drug application for Phenoptin in PKU next quarter. While 6R-BH4 is the active ingredient in Phenoptin, this development has no effect on our program for Phenoptin in PKU. 6R-BH4 works by an entirely different mechanism of action and metabolic pathway in PKU, and the safety data in the hypertension study did not change the safety profile of the drug.”