ARTICLE | Clinical News

BioMarin regulatory update

January 2, 2012 8:00 AM UTC

BioMarin said that EMA's CHMP recommended approval of an expansion to its biologics manufacturing facility in Novato, Calif. The company expects a final decision from EMA in 1Q12 on the expansion, which BioMarin expects to double the site's capabilities and support up to $1 billion in revenue for its enzyme replacement therapy portfolio. In November, FDA approved the expansion to manufacture mucopolysaccharidosis VI (MPS-IV) drug Naglazyme galsulfase. The expanded site will also be the initial site for the commercial production of MPS-IVA candidate GALNS ( BMN-110). The company said the Novato site is producing clinical trial materials for pipeline candidates, including GALNS, PEG- PAL (formerly Phenylase) for phenylketonuria (PKU), BMN-111 for achondroplasia and BMN-190 for late infantile neuronal ceroid lipofuscinosis, a form of Batten disease. BioMarin said the next phase in its manufacturing capabilities expansion will be at its facility in Ireland (see BioCentury, Dec. 12, 2011). ...