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Teva, Lundbeck say Azilect slows Parkinson's

TEL AVIV/STOCKHOLM - Teva Pharmaceutical Industries Ltd revealed positive results on Monday for its Azilect Parkinson's treatment, boosting its shares and those of Danish partner Lundbeck.

Tel Aviv-traded shares in Teva jumped 3.2 percent while Lundbeck was up 3.7 percent at 1336 GMT.

Teva, the world's biggest maker of generic drugs, said it intends to submit these 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 disease treatment to receive an indication for slowing the progress of the disease, the companies said.

‘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.

Teva's Copaxone became the No. 1 global treatment for multiple sclerosis in the first quarter.

‘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.

SALES TO JUMP

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,’ 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.

Bank Hapoalim analyst Gilad Sarig estimated Azilect's potential sales at $1 billion.

‘It is expected to become the leading drug in the Parkinson's market within a few years,’ he said in a research note, adding he is not changing his forecasts for the company until the timetable with the FDA becomes clear.

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.

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.