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Title: Azilect (Rasagiline) Shows Long-Term Promise For Patients With Parkinson's Disease

"Azilect (Rasagiline) Shows Long-Term Promise For Patients With Parkinson's Disease"

BERLIN, GERMANY -- June 7 2005 -- New data presented today at the 9th International Congress on Parkinson's disease, show that early treatment with Azilect (rasagiline 1 mg) once daily has a positive effect on the functional impairments associated with Parkinson's disease and that the effects of Azilect are maintained for up to 6.5 years1. The data are based on a long-term open label extension study of patients originally enrolled in the TEMPO trial [(TVP-1012) in Early Monotherapy for Parkinson's disease Outpatients], which compared the effects of early Azilect treatment versus a six month delay in initiating treatment. Results from this twelve month study evidenced the beneficial effect of early treatment over 12 months, and the open label extension followed both early start and delayed start patients for up to 6.5 years to ascertain whether this effect is maintained in the long term2. Results from this extension study showed a mean annual UPDRS decline for patients treated with Azilect of only 2-3 units compared with historical decline rates of 8-11 units in placebo-treated patients1, and comparison of early versus delayed start patients demonstrated a significant and persistent difference of 2.5 units between the two groups2 over the long-term extension period. The 404 patients, included at entry in the placebo controlled phase of the TEMPO study, had a mean duration of PD of 1.2 years and a mean UPDRS score of 25 units. The UPDRS is a research tool commonly used to measure a patient's ability to perform mental and motor tasks and activities of daily life. The long-term extension period show that of the 266 of patients who completed two years of treatment, 46% were adequately maintained on Azilect 1 mg once daily, without the need for additional dopaminergic therapy. The extension study also confirmed the long-term safety and tolerability of Azilect 1mg both as monotherapy and when administered concomitantly with dopaminergic agents1. "Patients treated just six months earlier with Azilect showed significantly less symptom progression and functional decline, and this advantage persisted for six years," commented Dr Robert Hauser, of the University of South Florida, Tampa General Hospital, USA. "The finding that it is possible to remain on Azilect monotherapy for a prolonged period of time, without the need for additional dopaminergic therapy, also evidences the long-term promise for Azilect therapy in patients who are started early in the course of the disease." The open label follow-up extension, which is still ongoing, was initiated in 85% of patients who completed the double-blind one year period of the study, and involved 32 centres in the United States and Canada1. Previously published findings from the 6-month period of the TEMPO study show that Azilect monotherapy provides a significant improvement in PD symptoms and quality of life compared to placebo in the early stages of the disease3,4. About Azilect Azilect is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a neurotransmitter that is critical for the regulation and coordination of movement. Azilect received approval from the EMEA in February 2005 as both a monotherapy and an adjunct therapy for Parkinson's disease, and will be marketed in Europe by Lundbeck and Teva as part of a long-term strategic alliance between the two companies. Parkinson's disease (PD) is a progressive neurodegenerative, chronic disruption of the central nervous system. Symptoms include tremor, slowness of movement, stiffness, gait and posture problems. As the disease progresses, symptoms worsen and the patient is likely to experience motor complications, including a fluctuating response to treatment. During "on" states, medication works effectively, but during "off" states, which correspond to the medication wearing off between doses, patients experience relatively poor function and mobility. PD affects men and women equally, and an estimated four million people worldwide are affected by the disease, which typically occurs at a late age. Approximately 1.6% of the population over the age of 65 suffer from PD. It is estimated that well over one million people in the EU suffer from PD. In 2003, the worldwide market for PD drugs was valued at USD 2.5 billion with approximately 40% of this in Europe. References 1. Lew MF et al. Long term efficacy of rasagiline in Parkinson's disease patients. Poster presented at ICPD, June 2005 2. Hauser RA et al. Early treatment with rasagiline is more beneficial than delayed treatment start in the long-term management of Parkinson's disease: analysis of the TEMPO ITT cohort. Poster presented at ICPD, June 2005 3. Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease. Arch Neurol 2002 Dec; 59: 1937-1943 4. Parkinson Study Group. A controlled, randomised, delayed-start study of rasagiline in early Parkinson disease. Arch Neurol 2004 Apr; 61: 561-566 SOURCE: H. Lundbeck A/S, Teva Pharmaceutical Industries Ltd.

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