Posted: 11/28/2011 09:50:27 AM PST
BioMarin Pharmaceutical Inc. said Monday that the Food and Drug Administration has given it the green light to begin manufacturing in an expanded facility in Novato.
BioMarin finished a 21,800-square-foot internal expansion of its building at 46 Galli Drive in April 2010. The $60 million project nearly tripled BioMarin's manufacturing capacity, all of which is based in Novato, to 40,000 square feet of clean room space.
"We are now approved to manufacture Naglazyme, basically our biggest enzyme replacement therapy product, in this facility," said Bob Purcell, a BioMairn spokesman.
Purcell said the newly licensed facility gives BioMarin the capacity to produce $1 billion in products, twice its previous capacity.
BioMarin is one of only a handful of companies focused on the orphan drug market. It was already making Naglazyme and another drug, Aldurazyme, in pre-existing facilities at the Novato site that were licensed by the FDA in 2003 and 2005. Both drugs treat an inherited metabolic disease that can cause tissue damage and mental retardation; and both drugs are produced by engineering hamster cells to make human proteins.
Purcell said BioMarin has two more products in the late stages of the approval process.
"Should they be approved in late 2012 we'll need to start ramping up," Purcell said. "We need to make sure that we have manufacturing capacity ready."
One of the new drug candidates is designed to treat Morquio
A Syndrome — 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 further expand its manufacturing capacity by buying a Pfizer Inc. facility in Cork, Ireland.
On Monday, shares of BioMarin stock, which trades on NASDAQ, rose $1.47, or 4.5 percent, to $33.72.