Sun received the recommendations in concurrence with the Sanofi-Aventis’s suit in the US against it, claiming that it is a case of infringement of patent and asking the US Food and Drug Administration not to award approval to market the drug in the US.
EMA said: “The Committee for Medicinal Plants for Human Use (CMPH) adopted a positive opinion, recommending the grant of marketing authorisation for the medicinal product Doceferez, 20mg and 80mg powder and solvent concentration. The application was made by the European subsidiary of Sun Pharma,” reported The Economic Times.
According to the agency, Dociferez has broad clinical anti-tumour activity against various types of cancer, such as lung, prostrate, gastric, head and neck. Sanofi-Aventis’ Taxotere has been trying to guard its patent over the cancer drug, which by industry estimates fetched sales of approximately $2.9bn for the company in 2009.