BioMarin Pharmaceutical Inc has received a notice from the United States Patent Office reporting allowance of claims covering once daily dosing methods for Kuvan (sapropterin dihydrochloride) in the treatment of phenylketonuria (PKU). The company expects that the patent will be officially issued later this year, and if issued, the patent's initial 20-year term would expire in 2024. The company has a number of other pending patent applications covering various aspects of Kuvan compositions and dosing.
"We believe the issuance of this patent will be significant in strengthening our proprietary position on Kuvan," said Jean-Jacques Bienaime, chief executive officer of BioMarin. "This patent would prevent potential competitors from using or copying Kuvan's approved dosing regimen. Based on the claims allowed by the USPTO, we believe that the once daily dosing regimen will prevent therapeutically equivalent generic competition to Kuvan while the patent is in force." Appetite
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). Kuvan is to be used in conjunction with a Phe-restricted diet.
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.
Kuvan has received orphan drug designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan has received seven years of orphan exclusivity in the United States and ten years of market exclusivity in the EU.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.