Teva, the world's biggest maker of generic drugs, said it intends to submit the results to the regulatory authorities in the United States and Europe.
It said the 1 mg tablets of its Azilect drug slowed the progression of Parkinson's disease in a Phase III trial. It promotes the drug with Lundbeck in the three major European markets: Britain, Germany and France.
Teva and Lundbeck said 1 mg tablets of Azilect met all three primary end points in the trial, as well as the secondary and additional end points, all with statistical significance.
The study also confirmed the safety and tolerability of Azilect and based on these results, Azilect could become the first Parkinson's treatment to receive an indication for slowing the progress of the disease, the companies said.
"Azilect, an innovative drug that was not very significant, becomes a drug with the potential to be a blockbuster," said Gal Reiter, an analyst at Israeli brokerage Clal Finance.
Until now Azilect has been indicated to treat the symptoms of Parkinson's.
"We will submit the FDA application in 2008 and hopefully within 12 months after that we will get approval (for the new indication)," Teva's chief R&D officer Ben-Zion Weiner told Reuters, adding it will seek European approval at the same time.
Weiner said Teva believes this will increase market share and sales of the product.
"These positive results could dramatically increase the market potential for Azilect, allowing Azilect to join Copaxone as another major Teva drug for neurological disorders," Shlomo Yanai, president and chief executive of Teva, said in a statement.
Global sales of Azilect rose 50 percent in the first quarter from a year earlier to $37.5 million. It sales were $120 million in 2007.
"If in the past we estimated the potential sales of the drug at $300 million, now we estimate that the potential has at least doubled," Clal Finance's Reiter said. "However, it will take time until Azilect's impact becomes substantial."
The analyst noted that while Azilect's patent runs until 2012, this clinical trial could enable an extension until 2017 in the United States.
Estimates point to Azilect's potential sales at $1 billion.
The study protocol was based on the recommendations and guidance of the U.S. 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.
Teva also said the 2 mg dose in the study met two of the three primary end points as well as the secondary end point. It was also found to be safe and well tolerated. Trial shows Teva's Azilect retards Parkinson's
This Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) 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.
Teva said that, 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 company said that 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. According to the company, the results mean that Azilect could become the first Parkinson's disease treatment to receive a label for disease modification.
Teva's Chief R&D Officer, Dr. Ben-Zion Weiner said, "This scientific breakthrough addresses one of the most critical unmet needs in the treatment of patients with Parkinson's disease."
Teva president and CEO Shlomo Yanai said, "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 centers.
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.
Teva says that more detailed data analysis will take place over the coming weeks and will be presented to the medical community at a later date.
Parkinson's Disease is an age-related degenerative disorder of the brain. Symptoms can include: tremor, stiffness, slowness of movement, and impaired balance. An estimated four million people worldwide suffer from the disease, which usually affects people over the age of 60.
Global sales of Azilect totaled $37.5 million in the first quarter, 50% more than in the corresponding quarter.
Teva said that the timing of the Azilect announcement was coincidental and was directly based on the trial results. Nevertheless, it should be noted that just last week, Mylan Laboratories Inc. (NYSE: MYL) and India's Natco Pharma Ltd. (BSE: 524816) announced plans to distribute a generic version of Copaxone, Teva's ethical treatment for multiple sclerosis.
They noted that at least three years would pass before a generic version of Copaxone could hit the market, if then, and there was no reason to doubt Teva's strength.
Teva also has treatments for cancer and neurological diseases in the pipeline, and the company believes that they have the potential to generate significant long-term growth.