Teva Pharmaceutical Industries Ltd. announced the successful completion of Adagio, the phase III study designed to demonstrate that Azilect 1 mg tablets can slow down the progression of Parkinson's disease. In the trial, 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.

Teva intends to submit these 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.

Azilect 1 mg tablets (rasagiline tablets) are indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial therapy alone and to be added to levodopa later in the disease. Azilect 1 mg tablets are currently available in 30 countries, including the US, Canada, Israel, Mexico, and most of the EU countries.

Teva's chief R&D Officer, Dr Ben-Zion Weiner, stated, "This scientific breakthrough addresses one of the most critical unmet needs in the treatment of patients with Parkinson's disease".

Shlomo Yanai, president and chief executive officer of Teva, added, "This achievement demonstrates the strength of Teva's innovative R&D capabilities and highlights our continued commitment to the development of treatments for the more challenging areas of neurological diseases. These positive results could dramatically increase the market potential for Azilect, allowing azilect to join Copaxone as another major Teva drug for neurological disorders."

The study protocol was based on the recommendations and guidance of the US Food and Drug Administration. The 18-month study, the first of its kind, is one of the largest conducted in Parkinson's disease, involving 1,176 patients with early Parkinson's disease in 14 countries and 129 medical centres.

In addition, the 2 mg dose in the study met two of the three primary end points as well as the secondary end point. The 2 mg dose was also found to be safe and well tolerated.