Pharma Mar S.A. applied for a patent term extension (PTE) for
their Australian patent 754073 on the basis of the listing on the
Australian Register of Therapeutic Goods (ARTG) of the product
APLIDIN. APLIDIN is indicated for the treatment of relapsed and
refractory multiple myeloma. The product is a co-pack of a vial of
the active ingredient plitidepsin in powder form, and an ampoule
containing PEG-35 castor oil and ethanol. In use, the
reconstitution solvents from the ampoule are added to the
plitidepsin powder, and the resulting mixture diluted with saline
or glucose solution. Plitidepsin is difficult to formulate, and the
invention of AU 754073 lies in the particular combination of
reconstitution solvents, which allow the preparation of a stable
aqueous solution. However, the reconstituted solution is not
sufficiently stable to be sold in that form, and this was a
decisive factor in the application for PTE being refused.
