Shares in US drugmaker MGI Pharma were in steep decline last week after it emerged that the US Food and Drug Administration had asked for another Phase III clinical trial before it would approve Saforis, the firm’s treatment for oral mucositis.

In patients with oral mucositis, the sensitive cells that line the mouth and digestive tract are damaged by the drugs or radiation used in cancer treatment. Severe mucositis is extremely painful, interferes with eating, increases the chance of serious infection and can lead to hospitalisation.

The company said it was ‘evaluating its options to maximise the value’ of the product, and said it did not expect a significant contribution financially from Saforis (glutamine) in 2007, although it insisted it would still reach profitability that year.

Prospects for Saforis have been affected by the approval in the USA last December of Amgen’s Kepivance (palifermin) for oral mucositis. This product, a recombinant form of keratinocyte growth factor, has been tipped to make $200 million in sales in this indication.

MGI acquired Saforis in 2004 when it bought Aesgen for $32 million.