Ferriprox® (deferiprone) Tablets
PBS Listing Recommended for 1 February 2004

---

30 September 2003 (Melbourne).

Orphan Australia is pleased to announce that the Pharmaceutical Benefits Advisory Committee (PBAC) have recommended that Ferriprox (deferiprone) 500 mg, 100 Tablets, developed by Apotex Inc., be made available as a pharmaceutical benefit under Section 100 of the National Health Act 1953.

The listing of Ferriprox as a pharmaceutical benefit is conditional upon subsequent negotiations, and is scheduled for listing on 1 February 2004 through the Highly Specialised Drugs Programme.

Ferriprox has been recommended for approval for the treatment of “Iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy; Iron overload in patients with thalassaemia major in whom desferrioxamine therapy has proven ineffective”.

Deferiprone was the first oral agent for the removal of excess iron in thalassaemia major patients to be registered around the world, with the first licensing of Ferriprox® (deferiprone) in the European Union in August 1999. Prior to its registration, the only existing treatment of iron overload in these patients was daily injections of desferrioxamine, over 8 to 12 hours. The availability of an oral formulation is expected to significantly improve the life of patients who are ineffectively treated with desferrioxamine. A copy of the Consumer Medicine Information is available here.

The Therapeutics Goods Administration (TGA) approved Ferriprox for marketing on 2nd April 2003. Ferriprox is registered in many countries around the world including the UK, France, Italy, Greece, Austria, Belgium, Denmark, Finland, Germany, Ireland, Luxembourg, Netherlands, Portugal, Spain, Sweden, Cyprus, Switzerland, Iran, Oman, Kuwait, Hong Kong, Brazil and Singapore.

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.

---

For further details please contact:

Gennaro D’Alessandro
Manager – New Products
Orphan Australia Pty Ltd
Telephone: 03 9769 5744
E-Mail

---

FERRIPROX® is a registered trademark of Apotex Inc., used under licence by Orphan Australia Pty. Ltd.