June 20th, 2001
Melbourne, Australia. June 20, 2001: Orphan Australia Pty Ltd submitted an application to the Therapeutic Goods Administration (TGA) in Australia to have Ferriprox™ (deferiprone) designated as an orphan drug. The application for orphan drug designation was approved on 22 May for the treatment of iron overload in patients with thalassaemia major unwilling or unable to take desferrioxamine therapy.
This designation represents a significant regulatory step for the treatment of patients having thalassaemia major. Ferriprox is an iron-chelating agent that can be taken orally.
Ferriprox (deferiprone) received marketing approval from the European Commission in August 1999 for fifteen countries including the United Kingdom, Sweden, Italy and Greece. It was granted approval in Switzerland on April 23, 2001. Marketing approval is pending in other countries.
Apotex and its affiliated companies is the largest Canadian-owned pharmaceutical Group with over 4,000 employees and an R&D commitment of over $1 billion for the next 10 years to develop both generic and innovative medicines.
Orphan Australia is a privately owned pharmaceutical company based in Melbourne, providing niche products to Australia, New Zealand and selected South East Asian countries. Orphan Australia specialises in the development, marketing and distribution of products typically used by specialists to treat serious and/or life threatening disorders.
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For Further Information Contact:
Orphan Australia
Gennaro D'Alessandro
gennaro@orphan.com.au
Telephone : (03) 9769 5744
Apotex, Canada
Mr. E. Betito
Director, Public and Government Affairs
ebetito@apotex.com
Telephone: +(416) 749-9300
