Takeda trials Teva Parkinson’s drug in Japan
pharmafile | January 9, 2015 | News story | Sales and Marketing | Azilect, CHMP, Copaxone, Parkinson's, Takeda, rasagiline
Takeda has begun late stage trials for Teva’s Parkinson’s disease drug Azilect in Japan, with the hopes of bringing the drug to market in the country.
Azilect (rasagiline) is already approved in 53 countries across the world, both in combination with common Parkinson’s treatment levodopa and as a monotherapy for the early stages of the disease, but it is not yet available in Japan.
Teva signed an agreement with Takeda in March last year granting the Japanese firm the rights commercialise the medicine in the country.
At the time of the deal, Doctor Michael Hayden, Teva’s president of global R&D and chief scientific officer said that Azilect would be “an important product for Japan, where the number of available treatment options for Parkinson’s disease remains limited”.
Focussing on Japanese patients, a Phase II/III trial will investigate the drug in combination with levodopa, with the primary endpoint of change in how often levodopa is not working well.
Another Phase III trial will test Azilect by itself, and patients will be assessed using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
The medicine works by increasing dopamine in the brain which may improve the motor symptoms characteristic of the condition. It has brought in solid revenue for Teva, with worldwide sales of $371 million in 2013.
In Europe, the drug is co-promoted with Lundbeck, and was recently granted a positive opinion for an informed consent application by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Azilect was the source of controversy last year, however, when US authorities began investigating Teva for alleged illegal sales and marketing activity surrounding the drug, as well as its big-selling multiple sclerosis treatment Copaxone (glatiramer acetate).
Parkinson’s disease typically develops in people over 60 years of age. Its symptoms include tremor, akinesia, muscular rigidity, and postural reflex disorder. It is estimated there are approximately four million worldwide diagnosed with the condition, including 150,000-180,000 people in Japan.
George Underwood
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