FDA Approves Expansion Of BioMarin Plant
NOVATO, Calif. (AP) — BioMarin Pharmaceutical Inc. said Monday the Food and Drug Administration approved the expansion of a manufacturing facility where the company makes several of its drugs and a key experimental drug.
The company said the manufacturing facility in Novato now has the capacity to produce $1 billion in products, twice its previous capacity. BioMarin received approval to make its drug Aldurazyme at the facility in 2003 and Naglazyme in 2005. Both drugs treat an inherited metabolic disease that can cause tissue damage and mental retardation. Naglazyme is the company's biggest-selling product.
The Novato facility is also producing some of Biomarin's drug candidates, and the company said it will use the expanded facility to make a new drug designed to treat Morquio A Syndrome if regulators approve that drug. Morquio A Syndrome is a genetic disease that causes skeletal and joint problems and shortness, and can also cause hearing loss, clouded vision and heart valve disease.
Earlier this year, BioMarin moved to expand its manufacturing capacity by buying a Pfizer Inc. facility in Cork, Ireland.
Shares of BioMarin rose 83 cents, or 2.6 percent, to $33.08 in morning trading.