Schwarz Pharma of Germany has said that the European Medicines Agency (EMEA) has approved Neupro, its transdermal product to treat early-stage Parkinson's disease.
Last year, Schwarz said that Neupro (rotigotine) has peak sales potential of around 350 million euros ($417m) a year. The company licensed the product from Aderis Pharmaceuticals last year for 58 million euros.
The patch is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Clinical trials have shown efficacy and safety in early Parkinson's disease patients and a potential for long term benefit, the company said. It hopes to launch Neurp in its first European markets ‘within the next weeks’.
Schwarz is also developing Neupro for restless legs syndrome, an indication that could add an additional 300 million euros to its sales potential, according to the company.
Meanwhile, Schwarz also announced on Friday that its full-year net loss swelled to 54 million euros from just 800,000 euros in 2004, in line with its own and analysts' guidance. The main reason for the increase was the licensing deal for Neupro.
Sales rose 4.6% in 2005 to 991 million euros, beating the company's own estimates of 930 million euros, helped by a recovery in sales of high blood pressure drug Univasc (moexipril) after generic rival Teva exited the US market for the drug.
Schwarz also said it expects to file for approval of fesoterodine, a treatment for overactive bladder syndrome, in March.