European Commission grants Aplidin orphan drug status for MM

Aplidin, Spanish biopharma company PharmaMar's second marine-derived compound in clinical development, has been granted orphan drug status by the European Commission for the treatment of multiple myeloma (MM) following adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).

Aplidin was granted Orphan Drug Designations for the treatment of acute lymphoblastic leukaemia in the EU in July 2003 and in the US in 2004.The US FDA also granted ODD for MM in 2004.

Isabel Lozano, ceo of PharmaMar, said: 'This orphan drug designation in Europe recognises the urgent need for new therapies for the treatment of multiple myeloma. This will support the sustained clinical development of Aplidin in MM, as well as in other haematological malignancies, which will start before the year end.'

Aplidin is a cyclic peptide, originally isolated from the marine tunicate Aplidium albicans, currently obtained by total synthesis. It induces apoptosis rapidly and persistently, inhibits VEGF secretion and blocks cell-cycle. It is currently in therapeutic exploratory clinical evaluation (phase II) in solid and haematological malignancies, including paediatrics.