BioMarin Pharmaceutical Inc announced that the temporary interruption of bulk production at Genzyme's Allston Landing manufacturing facility is not expected to have any impact on Aldurazyme supply or revenue to BioMarin or Genzyme. The last Aldurazyme fill at the Allston Landing facility was in September 2008. BioMarin has a total of approximately ten months of vialed inventory on hand, utilizes a second fill finish supplier and a third is expected to be qualified later this year. BioMarin manufactures Aldurazyme bulk material at its Novato facility and has adequate inventory in bulk and vialed form to meet expected ongoing Aldurazyme demand on a worldwide basis.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany.
Other product candidates include PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is in clinical development for the treatment of PKU and GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in phase-1/2 clinical development for the treatment of MPS IVA.