Alfacell Corporation has announced that the Therapeutic Goods Administration (TGA) in Australia has granted Onconase (ranpirnase) Orphan Drug status for the indication of malignant mesothelioma (MM). Onconase is also designated as an Orphan Drug for MM in Europe.
The TGA defines orphan drug products as "drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases." The TGA's Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees. In addition, orphan drug status in Australia confers priority evaluation for Onconase ahead of other therapies.
The Australian Mesothelioma Register, produced by the Epidemiology Unit of the National Occupational Health and Safety Commission (NOHSC), indicates that:
- Australia has the world's highest incidence rate of MM
- incidence rates of MM have been increasing there since 1965
- there is no indication of when MM incidence rates will start to decline
Onconase, Alfacell's lead investigational drug candidate, is currently being evaluated in a confirmatory Phase IIIb study as a treatment for MM, an asbestos-related cancer. Over 50 sites in the U.S., Canada, Europe, New Zealand and Australia are participating in the trial. The global MM market is estimated at $300M annually.