BioMarin Pharmaceutical Inc has received notice of priority review status for Kuvan (sapropterin dihydrochloride) as an oral treatment for patients with phenylketonuria (PKU) from Health Canada. Priority review provides for a shortened submission review of 180 days versus the standard twelve months. BioMarin plans to file a marketing application for Kuvan in Canada in the third quarter of 2009, and with priority review status, a decision for marketing approval is expected in the first half of 2010.

"Priority review status from Health Canada marks another milestone in our efforts to commercialize Kuvan worldwide as it is granted for serious, life-threatening or severely debilitating diseases for which no approved medical therapy exists in Canada," said Steve Aselage, senior vice president and chief business officer of BioMarin. "Along with our partners Merck Serono and Asubio, we remain dedicated to serving the PKU community and providing a therapeutic option in the management of this disease."

Kuvan (sapropterin dihydrochloride) Tablets are indicated in the United States to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU).

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase.

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.