A phase III study, ADAGIO, by Lundbeck partner Teva Pharmaceutical Industries shows that Azilect 1 mg tablets can slow the progression of Parkinson's disease. The 18-month study was one of the largest conducted in Parkinson's disease, involving 1,176 patients with early, untreated Parkinson's disease, in 14 countries and 129 medical centres.
Lundbeck writes in a press release that the trial showed the currently marketed Azilect 1 mg tablets met all three primary end points, as well as the secondary and additional end points, all with statistical significance. The study also confirmed the safety and tolerability of Azilect.
Jacob Tolstrup, head of communication and investor relations at Lundbeck told financial daily newspaper Børsen: "The Parkinson's disease market is very compact, and filled with old drugs and generic pharmaceuticals. The new data we have gained makes Azilect stand out from the crowd, and there is no doubt that it will affect sales significantly. But it is top line data, and we need to find out how to use it in our European marketing. It is difficult to give precise estimates for what we can expect."
Lundbeck markets Azilect in Europe, but on the three major European markets – UK, Germany and France – Teva and Lundbeck co-promote the drug. Teva markets Azilect in the US. In 2007, Lundbeck generated Azilect sales of DKK 168m (USD 34.5m).
Following the successful completion of the ADAGIO study, Teva will submit the results to the regulatory authorities in the US and Europe. Based on these results, Azilect could become the first Parkinson's disease treatment to receive a label for disease modification.
Lundbeck is headquartered in Copenhagen and employs approx. 5,300 people worldwide. The company is engaged in R&D, production, marketing and sales of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, Lundbeck's revenue was DKK 11bn (USD 2.3bn).