The FDA Approves Production Process Strategy Of Aplidin(R), New Marine-Derived Anti-Tumor Agent, Proposed By PharmaMar

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Oct 2008 - 4:00 PST

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The Food and Drug Administration (FDA) has accepted the proposal made by PharmaMar, of the Zeltia Group for the production process of Aplidin®, a new marine-derived anti-tumor agent, in clinical development for the treatment of hematological and solid tumors.

The starting materials for the initiation of the production process have also been approved. Approval from the FDA confirms the strategy PharmaMar has established for the production process of Aplidin®, a process that is already fully defined.

It is an FDA requirement that companies producing drugs submit full paperwork on the synthesis of their medicines. This information on the medicines synthesis together with the approval of the regulatory agency, are included in the registration dossier of a medicine.

About Aplidin®

Aplidin® (Plitidepsin) is a novel anti-tumour agent discovered in the Mediterranean tunicate Aplidium albicans and currently obtained by chemical synthesis. Aplidin® is PharmaMar's second most advanced compound in clinical development. Aplidin® leads to a rapid and persistent induction of apoptosis, inhibits secretion of vascular endothelial growth factor 1 (VEGF1,) and blocks the cell cycle. Aplidin® is being evaluated in preclinical studies and Phase II clinical trials in solid tumours and haematological malignancies, including paediatric tumours in Europe, and the United States. Clinical data have shown antitumour activity in multiple myeloma, renal cancer and aggressive lymphomas. Since late 2005, Aplidin® is undergoing studies in combination with other antitumour agents, as the basis for possible phase III registration studies.

PharmaMar

PharmaMar is the world-leading biopharmaceutical company of the Zeltia Group, and is committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. PharmaMar has four novel compounds in clinical development. Yondelis® has received Authorization for Commercialization from the European Commission for treating advanced soft tissue sarcoma. Yondelis® is currently being marketed in the European Union for the treatment of soft tissue sarcomas in adults after failure of standard therapy. Aplidin®, Zalypsis®, and Irvalec® are other marine-derived new agents in clinical development by PharmaMar, which also has a rich pipeline of preclinical candidates, and a strong R&D program.

PharmaMar