Marine Pharmacology and the Marine Pharmaceuticals Pipeline

As the renaissance in the pharmacology of marine natural products continues (Glaser and Mayer, Biochemical Pharmacology 78:440–448, 2009), the purpose of this project was to assess the status of the clinical marine pharmaceuticals pipeline. Results were the following: there were five FDA‐approved marine‐derived drugs in the US market, namely cytarabine for cancer (Cytosar‐U®, Depocyt®, FDA‐approved 1969), ziconotide for pain (Prialt®, FDA‐approved 2004), omega‐3‐acid ethyl esters for hypertriglyceridemia (Lovaza®, FDA‐approved 2004), eribulin mesylate for cancer (Halaven®, FDA‐approved 2010), brentuximab vedotin for cancer (Adcertis®, FDA‐approved 2011), while vidarabine as an antiviral (Vira‐A®, FDA‐approved 1976) was no longer available, and trabectedin for cancer (Yondelis®, FDA‐orphan drug approval 2005) being EU‐registered. The clinical marine pharmaceutical pipeline, recently reviewed (Mayer et al. TIPS 31:255–265, 2010), as of October 2012 consisted of 11 marine‐derived compounds in clinical development. These included three new monoclonal antibodies conjugated to synthetic dolastatin derivatives, that were in either Phase I, Phase II or Phase III clinical trials. Finally, the preclinical marine pharmacology pipeline remained a global enterprise with researchers from several countries reporting novel mechanisms of action for multiple marine chemicals (Mayer et al. Comparative Biochemistry and Physiology C 153: 191–222, 2011). We conclude that both marine pharmacology preclinical research as well as the clinical pharmaceutical pipeline remained very active in 2012. Supported by Midwestern University.