Rotigotine – Parkinson’s disease       Rotigotine – Restless Legs Syndrome

Rotigotine™ (SPM-962) - The First Once-a-Day Transdermal Patch to Treat Parkinson's Disease

Parkinson's Disease
This age-related, progressive, neurodegenerative disease affects as many as 1 million people in the US. Caused by the inability to produce enough dopamine, a neurotransmitter necessary for normal motor function, Parkinson's patients suffer from tremors, rigidity, slow or uncontrolled muscle movement, speech disorders, and gait and postural disturbances.

The Aderis Approach
Because most existing treatments for Parkinson's disease are available only in oral formulations, levels of medication in the bloodstream rise and fall, causing patients to experience fluctuating efficacy and substantial side effects. Recent studies have suggested that continuous dopaminergic stimulation (CDS) may prevent or delay the onset of side effects particularly abnormal movements called dyskinesia.¹

In keeping with our commitment to improve quality of life for people suffering from disease, Aderis initially developed rotigotine to be the first once-a-day transdermal patch to treat Parkinson's symptoms. Incorporating this proprietary non-ergot dopamine agonist and development expertise from our partner, SCHWARZ PHARMA AG, the "Parkinson Patch" drug delivery system should provide 24-hour sustained delivery of therapeutic levels of medication.

Development & Commercialization
In 1998, Aderis licensed worldwide development and commercialization rights for rotigotine to SCHWARZ PHARMA AG. There have been over 25 clinical studies performed with rotigotine to date. SCHWARZ PHARMA has reported that the two pivotal phase III trials in patients with early stage Parkinson's Disease have been completed. The first results of the double-blind, placebo-controlled studies seem to demonstrate the efficacy and safety of the Parkinson patch. The trial in the US enrolled 227 patients, while the European trial enrolled 561 patients. SCHWARZ PHARMA plans to file marketing applications for the treatment of early stage Parkinson's disease patients in both the US and Europe in the third quarter of 2004.

In the US, a third Phase III trial is being done in late stage patients and has enrolled 330 patients. SCHWARZ PHARMA has announced they will begin a fourth Phase III trial in late stage patients in Europe in the second quarter of 2004. Filing for approval in late stage patients is expected in the first quarter of 2006 immediately following the anticipated approval for early stage disease.

Related Information:

1 Continuous dopaminergic stimulation in early and advanced Parkinson's disease; F. Stocchi and C.W. Olanow. Neurology. 2004;62:S56-S63.

A Controlled Trial of Rotigotine Monotherapy in Early Parkinson's Disease; The Parkinson Study Group; Arch Neurol. 2003;60:1721-1728.

Rotigotine - A Better Night's Sleep: Once-a-Day Transdermal Patch to Treat Restless Legs Syndrome

Restless Legs Syndrome (RLS)
Restless Legs Syndrome is an under-diagnosed neurological condition that has components of both sleep and movement disorders. It affects 2-15% of the general population with current estimates of 12 million people in the US alone. With the cause still not completely understood, those with RLS have an irresistible urge to move their legs when lying down or sitting for prolonged periods of time, usually at night.

The Aderis Approach
Although there are currently no approved medications to treat RLS in the US, dopamine agonists have been shown to be effective. A lower-dose transdermal patch containing rotigotine, a non-ergot dopamine agonist being tested in Parkinson's disease, may be useful in providing the necessary dopaminergic stimulation needed to control the symptoms of Restless Legs Syndrome.

Development & Commercialization
In 1998, Aderis licensed worldwide development and commercialization rights for rotigotine to SCHWARZ PHARMA AG. In 2002, SCHWARZ PHARMA AG performed a pilot study in 68 patients that demonstrated rotigotine, a transdermal skin patch incorporating a novel dopamine agonist, produced a dose-dependent improvement in symptoms. SCHWARZ PHARMA is currently completing a European Phase IIb trial and should release the preliminary results in Q3 2004. Phase III testing is expected to begin in 2005.

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