Genzyme Updates Data on Gaucher Drug
From Associated Press (February 11, 2010)
CAMBRIDGE, Mass. -- Genzyme Corp. said Thursday a potential Gaucher
disease drug continued to show positive results after two years in
a midstage study.
The company presented positive one-year study data on the drug in
2009, and it is now in late-stage, or Phase 3, development.
In the updated results, the drug candidate eliglustat tartrate,
formerly Genz-112638, continued improvement in treating Gaucher,
which is a rare condition that harms the body's ability to process
fat. It can cause liver and neurological problems.
The midstage study involved 26 patients and 20 of those patients
completed two years of treatment.
Genzyme, based in Cambridge, Mass., recently made several changes
to its manufacturing leadership and operations following a year of
problems.
In June, the company shut down its manufacturing plant in the
Boston neighborhood of Allston to clean up viral contamination that
had been slowing down production of Cerezyme and Fabrazyme. The
virus was not harmful to people, but the shutdown cost the company
millions in revenue. Production restarted in September.
Meanwhile, in November, the Food and Drug Administration said it
found tiny particles of trash in drugs made by Genzyme, including
steel, rubber and fiber. The agency recommended that doctors
closely inspect vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme
and Thyrogen.
Cerezyme also treats Gaucher disease and Fabrazyme treats Fabry
disease, an inherited disorder caused by the buildup of a
particular type of fat in the body's cells.
Shares of Genzyme rose 1 cent to $54.51 in morning trading.
Posted: February 2010
