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Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
Date:8/19/2007

in

blood Phe level of 236 uM/L (29 percent) compared to a mean increase

of 3 uM/L (3 percent) in the placebo group (p<0.0001). Prior to

treatment, patients in the Kuvan group and placebo group had mean

blood Phe levels of 843 uM/L and 888 uM/L, respectively.

* After six weeks of treatment, 54 percent of patients treated with

Kuvan and 23 percent of patients in the placebo group had a blood

phenylalanine concentration below the recommended 600 uM/L level

(p=0.003).

* Blood phenylalanine concentrations fell by about 200 uM/L after one

week in the Kuvan group, and this reduction persisted for the

remaining five weeks of the study (p<0.0001).

* The type and incidence of adverse events was similar in the Kuvan

and placebo groups. Kuvan was well tolerated and investigators

reported that no serious adverse event occurred.

About Kuvan

Kuvan is an investigational oral small molecule therapeutic for the treatment of PKU. The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. Clinical data suggest that treatment with Kuvan results in significant reductions in blood Phe levels in BH4-responsive patients. It also may enable some patients to minimize or eliminate highly-restrictive dietary constraints by increasing Phe tolerance levels. BioMarin and Merck Serono estimate that Kuvan could be a potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world.

Kuvan has received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). If approved, it will receive seven years of market exclusi
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SOURCE BioMarin Pharmaceutical Inc.

Copyright©2007 PR Newswire.

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