Genzyme
Corporation (NASDAQ: GENZ) today announced that it has detected a
virus that impairs cell growth in one of six bioreactors at its Allston
Landing manufacturing facility. The company has decided to temporarily
interrupt bulk production at the plant to sanitize the facility. Genzyme
is collaborating with regulatory agencies as it works to resume
production. The company expects the plant to be fully operational by the
end of July.
The virus strain, Vesivirus 2117, has not been shown to cause human
infection. It is known to interfere with the growth of CHO cells used to
produce biologic drugs and was likely introduced through a nutrient used
in the manufacturing process. Genzyme has now confirmed that this virus
was the cause of declines in cell productivity at its Allston and Geel
facilities in two previous instances in 2008, which were subsequently
fully addressed. The company was able to detect the virus in this case
using a highly specific assay it developed after standard tests were
unable to identify the cause of the previous productivity declines.
Genzyme is adding steps to increase the robustness of its raw materials
screening and viral removal processes.
Current inventories for Cerezyme® (imiglucerase for
injection) and Fabrazyme® (agalsidase beta) are not
sufficient to meet projected global demand. The timing and extent of the
Cerezyme supply constraint is being clarified and will be communicated
as soon as possible. The company expects Fabrazyme supply constraints to
occur for a limited period beginning in September. The company will work
with physicians, patients and regulators to minimize the impact of this
constraint.
“The patients who need these therapies are our priority,” said Henri A.
Termeer, Genzyme’s chairman and chief executive officer. “We are
confident in the quality of the products produced in Allston and in our
ability to resolve the issue affecting the plant. The impact will be
temporary.”
Genzyme identified the virus at the Allston plant over the weekend. On
Monday morning, the company submitted information to the FDA and EMEA on
its findings. The company held a conference call with the FDA on Monday
afternoon. With regulatory input, Genzyme is finalizing its action plan
and assessing the business impact of this situation. The company will
provide updated financial guidance as soon as possible.
Conference Call Information
Genzyme will host a conference call today at 12:00 p.m. Eastern.
