Biotech giant Genzyme has shuttered a drug production complex after discovering a virus in a bioreactor used to produce its best selling drugs, Cerezyme and Fabrazyme.
The virus, Vesivirus 2117, is not thought to harm humans, according to company officials. It does affect growth of the cells used to produce the drugs, however. The tainted plant will stay closed for at least 6 weeks while decontamination takes place.
For about 8,000 people worldwide, the drugs are life-savers, although the temporary interruption in production should not pose significant risks to them.
Cerezyme is used for Gaucher disease, a hereditary condition in which an inactive enzyme causes fats to accumulate in multiple organs.
Fabrazyme is used to treat Fabry disease, another inherited enzyme deficiency that leads to fat build-ups in various organ systems as well.
As a result of the shutdown, Cerezyme patients could miss one or 2 treatments. Those taking Fabrazyme could miss up to 4 doses.
Patients usually receive IV infusions of the drugs every 2 weeks. Any missed doses will not result in significant health sequellae, since it takes more than a few missed treatments to result in significant reaccumulation of the fatty substances.
“It is not a life-and-death situation we’re dealing with here,’’ Henri Termeer, the company’s chief executive told the Boston Globe.
The production glitch will cost the company $200-$300 million in lost revenue, however. Last year, Cerezyme garnered $1.2 billion in revenue, about a quarter of the company’s total. Fabrazyme generated $500 million.
“This is an unusual event, but they’ll solve it and go on,” Leerink Swann’s John Sullivan told the Globe. “Traditionally, in cases like these, you worry about a market share shift. With these products, that is not a consideration.’’