Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. announced that they have mutually agreed to end their May 2003 alliance to co-promote Teva's Azilect (rasagiline tablets) for Parkinson's disease in the United States.
As a result, Teva's US innovative product marketing subsidiary, Teva Neuroscience, Inc., will have sole responsibility for the marketing of Azilect in the US and Teva will enjoy the full financial benefits from Azilect sales. Since 2003, Teva Neuroscience has more than doubled its field presence in preparation for this launch and has demonstrated its capabilities in its neurological franchise through its sales efforts and significant success with Copaxone (glatiramer acetate injection) for the reduction of relapses in relapsing-remitting multiple sclerosis.
As previously announced on May 17, 2006, once-daily Azilect received approval from the US Food and Drug Administration (FDA) as a treatment for Parkinson's disease both as initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease. Azilect will be available in the US by the end of this month.
A global phase II study, in which rasagiline is used as an adjunctive treatment in Alzheimer's patients treated with Eisai's Aricept, was initiated in 2004 and is currently on-going.
Azilect (rasagiline tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.
Azilect is contraindicated for concomitant use with: meperidine, other MAO inhibitors, tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, mirtazapine, cyclobenzaprine, sympathomimetic amines including over-the-counter cold preparations, and local anesthetics containing sympathomimetic vasoconstrictors. Patients taking Azilect should avoid tyramine-rich foods, beverages, and dietary supplements. It seems prudent, in general, to avoid the combination of Azilect with antidepressants. Caution should be used when Azilect is used concurrently with CYP1A2 inhibitors such as ciprofloxacin. Azilect should not be taken by patients with moderate to severe hepatic impairment or pheochromocytoma.
Side effects of Azilect as monotherapy include arthralgia and dyspepsia; and as adjunct to levodopa therapy include dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, arthralgia, nausea, constipation, dry mouth, rash, and somnolence.
Azilect was developed by Teva based on research originating from the Technion Israel Institute of Technology.