NOVATO -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) received U.S. Food and Drug Administration approval for its expanded manufacturing facility in Novato, a plant the company says will support up to $1 billion in revenue from its growing enzyme-replacement therapies.
"We are pleased with this first-cycle approval of our manufacturing facility expansion, which reflects our effective interactions with regulatory authorities and the high caliber of our technical operations team," said Jean-Jacques Bienaime, chief executive officer. "BioMarin has a strong track record in manufacturing enzyme replacement therapies."
The capital project over the past two years included more than doubling of commercial production capacity at the eight-building campus in the Bel Marin Keys industrial area of Novato, expansion administrative departments to a ninth building elsewhere in the city, upgrading utilities and laboratories, and planning further manufacturing growth in 2012.
In June, BioMarin announced the acquisition of a 133,000-square-foot Pfizer manufacturing plant in Cork, Ireland, for $48.5 million to support certain commercial production during expansion in Novato.
The latest approval of the upgraded Novato facility supports the manufacturing requirements for anticipated peak sales of commercial products while supporting several of BioMarin's clinical and preclinical programs, according to Mr. Bienaime. The Novato plant also produces clinical trial material for the pipeline of protein-based products, including GALNS for MPS IV, PEG-PAL for PKU, CNP analog for achondroplasia and a new biologic treatment to be disclosed soon.
"The facility expansion will also be the initial site of commercial production for GALNS for MPS IVA, if pivotal Phase 3 results are positive in the second half of 2012," Mr. Bienaime said. "The next phase in our manufacturing capabilities expansion will occur in our recently purchased facility in Ireland. Commercial production for some of our products inIreland, including GALNS, will provide additional manufacturing diversity and assure adequate capacity for commercial demand of our current and future products."
The multiproduct manufacturing plant in Novato was first licensed for production of Aldurazyme for MPS I in 2003, then Naglazyme for MPS VI in 2005. This facility expansion, adjacent to the current commercial plant, is now approved to manufacture Naglazyme. The latest facility approval provides BioMarin not only additional capacity but also redundancy for its largest commercial product.
The scale of operations at the cell culture stage of production was doubled and the scale of operations at the initial purification stage of production was tripled, according to BioMarin.
Also, numerous technology and automation control enhancements were implemented to facilitate manufacturing flexibility in accordance with good manufacturing practices, the company said. High-temperature, short-time (HTST) technology for pretreatment of media was implemented, lowering the risk for potential viral contamination, according to BioMarin.