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A clinical trial to assess the safety of a new enzyme replacement therapy for Gaucher disease produced by Transkaryotic Therapies Inc commenced in Israel in April 2004. In January 2005, Genzyme filed legal proceedings to stop the trial.
On 24 January 2005 Genzyme Corporation filed a lawsuit against Transkaryotic Therapies Inc (TKT) in the District Court of Tel-Aviv-Jaffa in Israel. The lawsuit alleges that TKT's Phase I/II clinical trial evaluating its investigational enzyme replacement therapy, known as Gene-Activated(R) glucocerebrosidase (GA-GCB), for the treatment of Gaucher disease infringes claims in one of Genzyme's Israeli patents which covers certain cell culture processes involved in the manufacture of glucocerebrosidase.
TKT is conducting the Phase I/II study to evaluate the safety of GA-GCB. The study which opened in April 2004 enrolled l2 patients with Type I Gaucher disease from several countries and is being led by Prof Ari Zimran of the Shaare Zedek Hospital in Jerusalem. 11 have completed the trial, one having stopped for personal reasons. TKT states that it expects to report results from this nine month study in the second half of 2005 and that the patients from the trial will enter an extension trial.
Genzyme claims that TKT has infringed Genzyme's patent by importing and using in Israel the GA-GCB product manufactured by the processes protected by Genzyme's patent. The Israeli patent No 100715 was granted on 2 December 2004.
Genzyme also filed a motion for a preliminary injunction to immediately stop the clinical trial, seize and destroy all GA-GCB being used to treat patients in TKT's ongoing clinical trial, and to prevent TKT from submitting data generated from the clinical trial to regulatory agencies. The trial judge has rejected Genzyme's request to stop the clinical trial on three occasions until a full hearing of the claims on the infringements of the patent is heard.
'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 A. 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.'
Genzyme has stated that a legal action of this type is customary in the protection of intellectual property and says it does not expect this action to 'adversely affect patients enrolled in TKT's ongoing clinical trial.
Jeremy Manuel OBE, Chairman of the UK Gauchers Association and Raul Chertkoff, President of the Israeli Gaucher Association issued a joint statement on behalf of the European Gaucher Alliance (EGA), an alliance of patient associations from 24 European countries: 'We support the work of all physicians and scientists in their quest to find more effective and less expensive treatments for Gaucher disease. Prof Zimran is one of the EGA's most popular and trusted physicians who has championed the rights of patients with Gaucher disease and whose work has improved the quality of life for many of them. We call on all involved to find a way for this matter to be resolved quickly without any adverse impact on patients or on the advancement of treatment for Gaucher disease.'
Footnote: Genzyme's legal case in Israel failed and the trial of the new enzyme has continued. On 21 April 2005, an agreed takeover bid was announced for TKT by Shire Pharmaceuticals Group, a UK company.
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Source: Gauchers News May 2005. Updated August 2006.
Copyright © Gauchers Association 2005.