Study Demonstrated Rotigotine Improves Symptoms of Early-Stage PD

Newswise — Data presented today at the 9th European Federation of Neurological Societies (EFNS) demonstrated that SCHWARZ PHARMA's rotigotine, which is currently under investigation for Parkinson's disease (PD), improved symptoms associated with early-stage PD. In addition, data from a second Phase III trial showed rotigotine also reduced "off" time and increased "on" time without troublesome dyskinesias in patients with advanced-stage PD already taking levodopa.

Rotigotine, a non-ergolinic dopamine agonist formulated as a patch, is under investigation for the treatment of Parkinson's disease. The patch, applied once-daily in clinical trials, is designed to continuously deliver rotigotine to the bloodstream through the skin (transdermally).

Data presented at EFNS indicated that in a clinical trial, rotigotine patch provides stable blood plasma levels of the medication over a 24-hour period.

SCHWARZ PHARMA filed a New Drug Application (NDA) for rotigotine with the U.S. Food and Drug Administration (FDA) in January 2005 and with the European Agency for the Evaluation of Medicinal Products (EMEA) in September 2004 for the treatment of early-stage Parkinson's disease. These applications are still under review.

Rotigotine in the treatment of early-stage PDWerner Poewe, MD, of Innsbruck Medical University, Innsbruck, Austria, presented data on the effect of rotigotine on patients with early-stage PD. In this double-blind, placebo-controlled, two-part study, 273 patients with early-stage PD were assigned to receive either rotigotine (n=177) or placebo (n=96) for six months. For the rotigotine treatment, patients were started on a 10 cm2 (delivering 2 mg/day) patch, increasing the patch size by 10 cm2 each week over three weeks to a maximum patch size of 30 cm2 (delivering 6 mg/day). The researchers measured changes in scores on parts II and III of the Unified Parkinson Disease Rating Scale (UPDRS). These two parts of the UPDRS assess a patient's ability to perform activities of daily living such as feeding and dressing oneself and evaluate motor symptoms of PD including tremor and rigidity.

During the study, patients in the rotigotine group showed an average improvement of 3.8 points in their UPDRS scores from baseline (their scores measured at the beginning of the study) compared to the placebo group, whose scores worsened by an average of 1.5 points from baseline. Ninety-seven percent of patients who completed the study continued on rotigotine in an open-label extension of the trial.

The most common adverse events (AEs) observed in study participants were application site reactions, nausea, somnolence (sleepiness) and dizziness.

Rotigotine as an adjunctive therapy in patients with advanced-stage PDPeter LeWitt, MD, professor of neurology and psychiatry at Wayne State University School of Medicine in Detroit, Michigan, and a clinical professor in the department of neuroscience at William Beaumont Hospital Research Institute in Royal Oak, Michigan, presented findings on rotigotine as an adjunctive treatment for advanced-stage PD. In a Phase III, double-blind, multicenter trial, 341 patients with advanced-stage PD being treated with levodopa were randomly assigned to additional therapy with two different strengths of rotigotine or placebo. Treatment groups included a rotigotine patch size of 40 cm2 (delivering 8 mg/day; n=113), a rotigotine patch size equivalent of 60 cm2 (delivering 12 mg/day; n=109) or placebo (n=119).

Patients assigned to the 40 cm2 rotigotine group experienced an average reduction in "off" time of 2.7 hours over a 24-hour period compared to baseline. Patients assigned to the 60 cm2 rotigotine group experienced an average reduction of 2.1 hours in "off" time over a 24-hour period compared to baseline and patients assigned to the placebo group experienced an average reduction of 0.9 hours in "off" time compared to baseline. Ninety-nine percent of patients who completed the study continued on rotigotine in an open-label extension of the trial.

The most common AEs observed in study participants were application site reactions, somnolence (sleepiness), nausea and dizziness.

SCHWARZ PHARMA's NDA for rotigotine is for the treatment of early-stage PD. An estimated 4 million people suffer from PD worldwide, including about 1.5 million Americans. Patients with PD often experience trouble walking, tremors, dyskinesia, rigidity, slowness of movement (bradykinesia) and impaired balance. Symptoms of PD may appear at any age, but the average age of onset is 60 years. Young-onset PD (age 40 or younger) is estimated to occur in five to ten percent of patients. Roughly five to ten percent of PD patients have a family history of PD, suggesting that a genetic factor may be involved. Dopamine agonists are an important pharmacologic component in the treatment of PD and mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. Dopamine-producing cells in the brain become damaged and die in patients with PD, resulting in a variety of motor coordination disorders.

SCHWARZ PHARMA, Inc. is the US Marketing and Sales organization within the SCHWARZ PHARMA group. SCHWARZ PHARMA AG (headquartered in Monheim, Germany) develops and markets innovative drugs for unmet medical needs with a focus on neurology, urology, cardiovascular and gastrointestinal diseases. The company is investing in development projects targeting diseases such as Parkinson's disease, restless legs syndrome, epilepsy, neuropathic pain and overactive bladder syndrome. The company has a strong international presence with subsidiaries in Europe, the United States and Asia. Shares of SCHWARZ PHARMA AG are traded on the Frankfurt and Duesseldorf stock exchanges.

This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation affecting SCHWARZ PHARMA AG, exchange rate fluctuations and hiring and retention of its employees.