Attn: News / Medical Editors
December 18, 2003
For Immediate Release
European Court Rules Against Blood Doctor, Nancy Olivieri, in her Challenge of the Marketing Authorization of
Ferriprox® (Deferiprone). Decision Ensures Patient Access To Life-Saving Treatment
LUXEMBORUG – The Court of Justice of the European Communities, Court of First Instance dismissed as inadmissible the
case brought by Dr. Nancy Olivieri against the European Commission (EC) challenging its marketing approval for Ferriprox®
(deferiprone).
In its decision, the Court affirmed that the European Agency for the Evaluation of Medicinal Products (EMEA) had properly
examined relevant data when granting the marketing authorization for Ferriprox. In contrast to her claim, the Court found
that the information Olivieri sent "enabled the Commission to confirm, in the interest of public health, that the
particulars and documents on the basis of which the marketing authorization was authorized were both complete and correct".
"This is outstanding news for thalassemia patients throughout Europe", stated Victor Hoffbrand, a leading hematologist
who has extensively studied deferiprone. "Prior to the approval of Ferriprox, only one drug was available to extend the
life of patients with thalassemia. The Court's decision is consistent with the experience of scientists worldwide, who
have documented the benefits of Ferriprox, both in terms of decreased iron-induced toxicity and improved cardiac function".
Children born with Thalassemia Major require monthly or more frequent blood transfusions, starting in the first year and
which are maintained for life. The iron that is accumulated from transfusions causes organ damage and premature death.
Prior to the approval of the orally active medication Ferriprox, only one product Desferal®, was available for the removal
of iron. Desferal is an injectable product that is normally administered intravenously or in the fat under the skin over
an 8-12 hour infusion, at least 5 days per week. Treatment is generally initiated by two or three years of age and has to
be maintained for life.
Treatment with Desferal is often rejected as children reach their teen years, with the consequence that the effectiveness
of Desferal is lost. In addition, recent evidence has shown that Desferal does not protect patients against iron induced
cardiac toxicity in a significant number of patients.
"The approval of Ferriprox was the most significant event in the treatment of transfusional iron overload over the past
two decades. The extensive additional safety and efficacy information that is now available for Ferriprox confirms that
this drug is an important instrument to extend the life of patients with thalassemia" expressed Dr. Fernando Tricta, Medical
Director of Apotex. "The Court's decision is a major victory for the treatment of thalassemia patients," he concluded.
News of the Court's decision was well received in the thalassemia community. "Patients in the United Kingdom are thrilled by
what this news means to them personally and that they are assured of continued access to this potentially life-saving
medication", stated Michael Michael, President of the United Kingdom Thalassemia Society.
Ferriprox has been approved as a life-saving alternative for patients in 29 countries, including countries in the European
Community, Switzerland, Cyprus, Iran, Australia, Oman, Kuwait, China, Hong Kong, Brazil and Singapore. More than 50
peer-reviewed publications address the safety and efficacy of this product for the treatment of transfusional iron
overload.
The current indication for Ferriprox in Europe is "For the treatment of iron overload in patients with thalassemia
major for whom deferoxamine therapy is contraindicated or who present serious toxicity with deferoxamine therapy".
This indication is currently under review by the EMEA to bring it in line with the current scientific knowledge
regarding the safety and efficacy of Ferriprox.
-30- Executive Summary of Background Information For
additional information, please contact:
Mr. Elie Betito
Director, Public & Government Affairs
Tel: (416) 749-9300 Ext. 7366
Fax: (416) 401-3835
E-mail: ebetito@apotex.com
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