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The Food and Drug Administration have accepted PharmaMar’s proposal for the production process of Aplidin –a new marine-derived antitumour agent – for the treatment of haematological and solid tumours.
The FDA require that any company producing drugs should admit full paperwork on the synthesis of their medicine. Along with the main drug approval, PharmaMar have also been given approval for the starting materials needed in the initiation of the production process for Aplidin.
Aplidin is the pharmaceutical company’s second most advanced compound in clinical development.
The drug, which is a novel antitumour agent discovered in the Mediterranean tunicate Aplidin albicans and currently obtained by chemical synthesis, has been undergoing studies since 2005 in combination with other antitumour agents, as the basis for possible phase III registration studies.