In addition, Genzyme filed a motion for preliminary injunction to immediately seize and destroy all Gene-Activated glucocerebrosidase (GA-GCB) being used to treat patients in TKT’s ongoing clinical trial and to prevent the company from submitting data generated from the clinical trial to regulatory agencies.
“We believe Genzyme’s efforts to try and disrupt our ongoing clinical development of GA-GCB are an improper attempt to extend its monopoly in the area of Gaucher disease,” said Kerry Flynn, vice president of intellectual property and licensing at TKT. “We do not believe we infringe any valid claim or that there is a reasonable likelihood that this unprecedented tactic will interrupt our clinical trial. We intend to honor our commitment to continue treating our Gaucher patients with GA-GCB.”
TKT is conducting an open-label phase I/II study to evaluate the safety and clinical activity of GA-GCB and expects to report top-line data from this study in the second half of 2005.
Gaucher disease is the most common of the inherited lysosomal storage diseases and is caused by a deficiency of the enzyme glucocerebrosidase. As a result of this deficiency, certain lipids accumulate in specific cells of the liver, spleen, and bone marrow causing significant clinical symptoms in the patient, including enlargement of the liver and spleen, hematologic abnormalities, and bone disease.