Attn: News Editors
For Immediate Release
April 10, 2000
European Court Rejects Olivieris Bid To Annul The Approval of
Life-Saving Drug
EC Takes Strong Position in Defense of Their Decision
TORONTO, ONTARIO, CANADA The Court of First Instance of the European Union
released its ruling regarding Dr. Nancy Olivieris challenge of the European
Commission and rejected her bid to have the approval of FerriproxÔ
annulled. FerriproxÔ is the only alternative for the treatment
of iron overload, and it has been approved for patients unable to take, DesferalÔ . For the first time, these patients are provided an opportunity
to reduce life-threatening levels of iron from their body by taking FerriproxÔ .
On August 25, 1999, the European Commission approved FerriproxÔ after a thorough review of Dr. Olivieris claims. In November
1999, she filed a suit against the European Commission challenging its approval.
Specifically, the Court ruling issued relates to an "Application
for suspension of the operation of the Commission decision of 25 August 1999 granting
marketing authorization for the medicinal product for human use known as
Ferriprox."
The Court ruled against Dr. Olivieri and concluded that "the
conditions necessary for granting the suspension requested have not been satisfied"
and the President of the Court of First Instance ordered that application for interim
relief be dismissed.
Jack Kay, Apotex President and COO welcomed the decision and stated
"I anticipate this would be the pattern for any other claims that Dr. Olivieri
files". He was particularly encouraged by the strong position taken by the European
Commission in defense of their decision on the approval of FerriproxÔ
and noted that "they refuted every salient claim registered by Dr. Olivieri".
Dr. Fernando Tricta, Medical Director for Apotex was pleased as this decision allows
FerriproxÔ to continue to be given to those patients who
cannot take DesferalÔ .
FerriproxÔ is a trademark of Apotex Inc. and DesferalÔ is a trademark of Novartis Inc.
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For additional information, please contact:
Elie Betito
Director, Public & Government Affairs
Apotex Inc.
Tel: (416) 749-9300
Fax: (416) 401-3835
E-mail: ebetito@apotex.ca