Scotia's survival chances lifted by EMEA's reversal of Foscan decision

Scotia Holdings of the UK, which went into administration earlier thisyear (Marketletter February 5), has been thrown a lifeline after its application to market Foscan (temoporfin), a light-activated anticancer drug, was approved by the European Medicines Evaluation Agency.

The EMEA's Committee for Proprietary Medicinal Products reversed its previous negative opinion on the drug following a two-day hearing which ended on June 27. Foscan was rejected by the CPMP as a treatment for advanced head and neck squamous cell carcinoma at the end of January but the CPMP changed its mind after hearing testimony from a panel of European experts and company officials.

Commenting on its volte face, the CPMP said that, "on the basis of quality, safety and efficacy data submitted, [it] considers that there is a favorable benefit to risk balance for Foscan." The drug has been approved for use as a palliative treatment in patients who have failed prior therapies and are unsuitable for radiotherapy, surgery or systemic chemotherapy.