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Azilect Improves Quality of Life in Early Parkinson's Disease Patients

First treatment to demonstrate improved QoL in early PD compared to placebo

COPENHAGEN, DENMARK, and JERUSALEM, ISRAEL -- May 15, 2006 -- Azilect (rasagiline) 1 mg once daily monotherapy improves the quality of life (QoL) of patients suffering from early Parkinson's disease (PD), according to new data published in Movement Disorders.

Azilect is the first drug to demonstrate improvement in QoL in the treatment of this chronic progressive disease, compared to placebo.1

Traditionally, researchers assess the efficacy of anti-parkinsonian drugs using motor outcomes such as rest tremors, bradykinesia, rigidity and postural disturbances.1,2 However, depression, and other non-motor symptoms, as well as diminished social function are sometimes more important than motor function in determining patients' overall QoL.1 In order to assess changes in patients' QoL, the TEMPO study investigators used the Parkinson Disease Quality of Life Questionnaire (PDQUALIF)3

Results from a cohort of 266 patients showed that treatment with Azilect significantly improved QoL after six months, with benefits emerging when first measured after 14 weeks of treatment. In contrast, QoL steadily worsened in patients receiving placebo.1

Dr. Kevin Biglan, University of Rochester, Rochester, New York, and lead author, commented, "Previous analysis demonstrate that Rasagiline (Azilect) improves the motor symptoms of Parkinson's disease, however, this recently published data suggest that Rasagiline also improves quality of life in early Parkinson's disease."

Improvements in the self-image/sexuality domain and, to a lesser extent, social role, drove most of the improvement in overall quality of life. The self-image/sexuality domain assesses the effect PD symptoms have on communication, intimacy, sexual desirability, and family roles.

Mary Baker, President of the European Parkinson's Disease Association, commented: "Parkinson's disease has a considerable impact on the quality of life of patient's and their families, with symptoms of tremor, rigidity, and slowness of movement compromising the ability to function from the early stages of the disease. These results are encouraging as they indicate that improved quality of life may be achieved with an available treatment."

The paper is based on data collected in the TEMPO trial [(TVP-1012) in Early Monotherapy for Parkinson's disease Outpatients], which demonstrated that Azilect is an effective and well-tolerated treatment in early disease and its earlier use can significantly delay the progression of PD symptoms.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 essential for the regulation and coordination of movement. Azilect received approval from the EMEA in 2005 as both a monotherapy and an adjunct therapy for Parkinson's disease, and is marketed in Europe by Lundbeck and Teva as part of a long-term strategic alliance between the two companies.

Parkinson Disease Quality of Life Questionnaire (PDQUALIF)
PDQUALIF is an example of a disease-specific measure that assesses aspects that are relevant to a particular condition. PDQUALIF consists of 32 questions that patients score on a 5-point scale from much better to much worse. The total score ranges from 0 to 128, with higher scores signifying worse QoL.5

The questionnaire assesses changes in seven individual 'domains' which can influence patients' QoL: social role; self-image/sexuality; sleep; outlook (concern for the future5); physical function; independence; and urinary function.1

Parkinson's disease
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 the disease, which typically occurs at a late age, affects an estimated four million people worldwide. Approximately 1.6% of the population over the age of 65 suffers from PD. It is estimated that well over one million people in the EU suffer from PD. In 2005, the worldwide market for PD drugs was valued at USD 2.5 billion with approximately 40% of this in Europe.


REFERENCES:
1. Biglan KM, Schwid S, Eberly S, Blindauer K, Fahn S, Goren T, et al. Rasagiline improves quality of life in patients with early Parkinson's disease. Movement Disorders 2006
2. Thanvi BR, Munshi SK, Vijaykumar N, Lo TCN. Neuropsychiatric non-motor aspects of Parkinson's disease. Postgrad Med J 2003;79:561-565
3. Parkinson Study Group. A Controlled Trial of Rasagiline in Early Parkinson's Disease (The TEMPO study). Arch Neurol 2002 Dec;59(12):1937-43
4. Parkinson Study Group. A Controlled, Randomised, Delayed-Start Study of Rasagiline in Early Parkinson disease. Arch Neurol 2004 Apr; 61:561-566
5. Welsh M, McDermott MP, Holloway RG, Plumb S, Pfeiffer R, Hubble J. Development and Testing of the Parkinson's Disease Quality of Life Scale. Movement Disorders 2003;18:637–645


SOURCE: H. Lundbeck A/S and Teva Pharmaceutical Industries Ltd.

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