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news.Æterna Zentaris, a late-stage drug development company specialized in oncology and endocrinology, has obtained a positive opinion for orphan medicinal product designation for its compound perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of multiple myeloma.
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Æterna Zentaris’ partner and licensee for perifosine in the North American market, Keryx Biopharmaceuticals, has already received orphan drug designation for perifosine for the treatment of multiple myeloma from the US FDA.
Juergen Engel, president and CEO of Æterna Zentaris, said: “We are very pleased with the positive opinion which is summarized by the COMP as follows: ‘The preclinical data and the preliminary clinical data obtained with perifosine justifies the claim on a clinically relevant advantage based in particular on the response obtained in relapsed and refractory multiple myeloma patients.
“Furthermore, perifosine is intended for oral administration, compared to the currently available parenteral treatments. This supports the assumption for a major contribution to patient care with regards to convenience and avoidance of a more aggressive administration route.”