After a long rough patch, things are looking up for Basle-based Basilea Pharmaceutica. The company's once-daily oral treatment for adults with severe chronic hand eczema, Toctino (alitretinoin), has been approved by Swissmedic, the Swiss regulatory authority. Analysts estimate that annual sales of the drug, which has already been launched in Germany, Denmark and the UK, could potentially reach several hundred million Swiss francs, reports the Swiss newspaper Neue Zurcher Zeitung.
For 2009, however, Basilea has pencilled in sales of 15-20 million Swiss francs ($14.7-$19.6 million), a drop in the ocean given that the company burns through 12-13million francs a month. Still, if the drug is soon approved in several other European Union countries, the gulf between revenue and expenditure will close.
Basilea is still awaiting US approval for its other key drug, an antibiotic for skin infections called Zeftera (ceftobiprole. Basilea is developing the drug with Johnson & Johnson and, in late 2008, the Food and Drug Administration refused to approve it, concluding that J&J's clinical testing procedures were deficient. Now the problems with the data identified by the FDA have been rectified, and it has been resubmitted, with a decision expected in late 2009 or early 2010.
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