Leukaemia research gives Bresagen gets a decade of market exclusivity

Bresagen (ASX: BGN) has been granted a 10-year head start on the development of its anti-leukaemia drug E21R.

The Adelaide company today announced that the European Commission had designated E21R an orphan medicinal product, granting the drug a decade's worth of market exclusivity.

The orphan medicinal product regulation was introduced in Europe in January 2000 to encourage the development of medicinal products for rare diseases or those with a limited range of treatments.

Today's announcement gives E21R, which is currently in clinical trials in the United Kingdom and Australia, exempt status for the disease juvenile myelomonocytic leukaemia (JMML).

Bresagen business development manager Dr James Anderson said the status meant no other drugs could be marketed for the disease, unless they were proved to be superior.

The status also brought with it financial assistance, which could be in the form of waived regulatory fees or subsidies for trials.

Anderson said the drug had already shown to be safe in early trials, with a phase II study now poised to start.

He said the trial would be run by Bresagen collaborator and listed UK company, British Biotechnology, which holds the commercialisation rights to the product.

Trials will also take place in Australia, focusing on chronic myelomonocytic leukaemia.

JMMI affects thousands of children worldwide, with most of those diagnosed aged under two years.

Current treatment involves bone marrow transplantation and chemotherapy, with a five-year survival rate occurring in just five per cent of cases.