Healthcare Industry News: Restless Legs Syndrome
News Release - July 16, 2007
SCHWARZ PHARMA and UCB, Inc. Announce U.S. Launch of Neupro(R) (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's DiseaseCompanies Also Kick Off PD-Aware, a Grassroots Parkinson's Disease Education Campaign
MONHEIM, Germany, July 16 (HSMN NewsFeed) -- SCHWARZ PHARMA and UCB, Inc. announced today that NeuproŽ (Rotigotine Transdermal System), a new once-daily transdermal dopamine agonist approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, is now commercially available in retail pharmacies throughout the United States. NeuproŽ will be co-promoted by SCHWARZ PHARMA and UCB, Inc. These companies have dedicated sales forces that will immediately begin reaching out to physicians who treat Parkinson's disease nationwide.
In conjunction with the U.S. launch, the companies are also kicking off PD-Aware, a public education campaign which aims to raise the profile of Parkinson's disease. The campaign will highlight the experiences and personal achievements of Parkinson's patients in order to increase understanding of the disease and highlight the latest treatment options, including NeuproŽ.
"Disabling Parkinson's symptoms can be well controlled with available medications, but may return as the effects of Parkinson's disease medications wear off," said C. Warren Olanow, M.D., Professor and Chair of Neurology, and Professor of Neuroscience at the Mount Sinai School of Medicine in New York City. "Neupro is the first transdermal or patch formulation available for the treatment of Parkinson's disease. It provides continuous drug delivery for 24 hours, throughout the day and night. As a new treatment option for early-stage Parkinson's patients, the Neupro patch helps control symptoms with once-daily dosing."
The U.S. Food and Drug Administration (FDA) approved NeuproŽ on May 9, 2007 based on results from 15 multinational clinical trials, which involved more than 1,500 patients with Parkinson's disease. The clinical trials demonstrated that NeuproŽ was efficacious and generally well-tolerated for early-stage Parkinson's disease, with a low potential for drug-drug interactions. NeuproŽ is currently available in the United States in three strengths: 2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours.
"The FDA's recognition of Neupro as a beneficial therapy for many Parkinson's disease patients is a momentous achievement for our company," said Rich Denness, Chief Executive Officer of SCHWARZ PHARMA Inc., USA. "We are proud to offer an effective treatment that controls the symptoms of early- stage Parkinson's disease by providing stable, continuous delivery of medication over a 24-hour period. We are excited to continue working with physicians and their patients who have Parkinson's disease, and we remain committed to educating the Parkinson's community about this new therapy."
NeuproŽ, with the active ingredient rotigotine, is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. NeuproŽ is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. The system is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Patients receiving NeuproŽ initiate treatment with a 2 mg/24 hours patch and titrate in 2 mg/24 hours increments each week until the optimal effect is observed. The administration of rotigotine transdermal system offers simple, once-daily dosing, and it is easy to use.
Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa. Since March 2006, the drug has been available on the European market and has been launched by SCHWARZ PHARMA AG in 14 countries within Europe, including Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, Spain, Finland, Poland, Slovakia and the Czech Republic.
About Parkinson's Disease
Parkinson's disease is a progressive disorder of the central nervous system. The patients - roughly four million worldwide, including approximately one million people in the United States - suffer primarily from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists are drugs that attempt to compensate for this lack of dopamine.
Important Safety Information
NeuproŽ is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. Some patients treated with NeuproŽ reported falling asleep while engaged in activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Some patients perceived no warning signs, such as excessive drowsiness. Hallucinations were reported in 2.0% of patients treated with NeuproŽ compared to 0.7% of patients on placebo. NeuproŽ should be used with caution in patients, especially those at risk for cardiovascular disease, because of the potential for symptomatic hypotension, syncope, elevated heart rate, elevated blood pressure, fluid retention, and/or weight gain. All Parkinson's disease patients are at a higher risk for melanoma and should be monitored regularly. The most commonly reported side effects in clinical trials were nausea, application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Some subjects who received NeuproŽ experienced a decline in blood hemoglobin levels (about 2% relative to subjects who received placebo). It is not known whether this change is readily reversible with discontinuation of NeuproŽ.
For full prescribing information, please visit www.neupro.com.
SCHWARZ PHARMA AG (headquartered in Monheim, Germany) is a member of UCB-Group, Brussels, Belgium (www.ucb-group.com). UCB is listed on the Euronext Brussels Exchange and owns 87.6% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA develops and markets innovative drugs for unmet medical problems. The company focuses on search and development in the therapeutic areas of the Central Nervous System (CNS) as well as cardiovascular and gastro-intestinal diseases. It has a substantial late-stage pipeline with development projects for the treatment of Parkinson's disease, Restless Legs Syndrome, epilepsy and neuropathic pain.
The company has a strong international presence with subsidiaries in Europe, USA and Asia.
UCB is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing more than 8,400 people in over 40 countries, UCB achieved revenue of 2.5 billion euro in 2006.
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.
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Source: SCHWARZ PHARMA
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