Otsuka Pharmaceutical Co., Ltd.

February 22, 2013

The First Transdermal Dopamin Agonist in Japan Neupro® Patch, For Both Parkinson's Disease and Restless Legs Syndrome, To Be Launched on February 26

  • Once-a-day application of transdermal dopamine agonist*1 system helps maintain a stable blood concentration of the drug treatment for 24 hours
  • Parkinson's disease patients are dissatisfied with their treatment, and are long awaiting a drug able to provide stable efficacy throughout the day to overcome their daily difficulties, such as not being able to move upon awakening
  • There are estimated to be approximately 140,000 Parkinson's disease patients in Japan, and the number of patients is rising with the aging society

Tokyo, Japan, February 22, 2013 - Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) today announced the launch of Neupro® Patch (chemical name: rotigotine) indicated for both the treatment of Parkinson's disease and Restless Legs Syndrome*2 in Japan, on February 26, 2013.

Neupro® Patch is the only transdermal dopamine agonist system available in the world, which only needs to be applied once a day, enabling a clinically-effective blood drug concentration via stable drug delivery throughout a 24-hour period.

Approximately 140,000 Parkinson's disease patients are estimated to be living in Japan, and those with progressive disease are more likely to experience drug efficacy diminishing or ceasing during certain times of the day, and as a result their daily living activities are affected. These patients often experience the difficulty and inconvenience of drug efficacy diminishing or ceasing during late evening or early in the morning, manifesting their symptoms. As a result, patients are often sleep-deprived, which further affects their performance the following morning. Patients often find it distressing not being able to spend their mornings actively, since even basic activities such as going to the toilet, getting dressed, and taking meals, are affected. Neupro® Patch is expected to provide relief for both patients and their caregivers, as it needs to be applied only once daily in order to achieve a stable blood drug concentration for 24 hours.

Restless Legs Syndrome is characterized by abnormal sensations, particularly in patients' calves, thighs and feet. Patients are not able to stay still due to these unpleasant sensations which are often expressed as creeping, itchy, or prickly feelings within or around the legs, although the expression varies from patient to patient. These sensations are felt at rest in the evening, such as at bedtime, and are known to prevent sound sleep.

Patients with Restless Legs Syndrome may also suffer when sedentary during daytime hours as well. Neupro® Patch can alleviate Restless Legs Syndrome symptoms throughout the day via simple application of a once-a-day patch which delivers a stable dopaminergic treatment lasting for 24 hours.

Otsuka Pharmaceutical acquired in 2002 the exclusive rights for developing and marketing Neupro® Patch in Japan. Outside of Japan, the drug is known as Neupro®, marketed in 35 countries by the product's owner, UCB, the global biopharmaceutical company based in Belgium. Otsuka Pharmaceutical is pleased to announce the launch of Neupro® Patch in Japan - we will strive to address unmet medical needs of Parkinson's disease and Restless Legs Syndrome in Japan.

  • *1:Dopamine agonists work by binding to and stimulating dopamine receptors
  • *2:Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults

About Parkinson's disease

Parkinson's disease is a degenerative neurological disease, typically known for four key symptoms, which are tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing), bradykinesia (slowness or loss or spontaneous movement), and postural reflex impairment. Most Parkinson's disease patients are middle-aged or older and in Japan the prevalence rate of the disease is approximately one in a thousand people. Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, and its prevalence is expected to increase with the aging of the population.

Patients with Parkinson's disease who are administered treatment by conventional drug delivery methods often experience a diminution or cessation of drug efficacy, for example during night time to early in the morning. Patients therefore face difficulties making natural movements during sleep or going to the toilet after waking, which imposes a burden not only on patients but on their caregivers as well.

It is important to maintain a certain level of plasma dopamine concentration throughout the day in order to suppress various symptoms associated with the disease. An easy-to-use, convenient dopamine agonist that enables patients to continue taking the drug for long-term treatment has been long hoped for.

About Restless Leg Syndrome

Restless Leg Syndrome (abbreviated below as RLS ) is also known as "muzu-muzu ashi" syndrome in Japan, or Willis-Ekbom disease after Dr. Thomas Willis, who first described RSL and Dr.Karl-Axel Ekbom, who deeply studied the condition and named it. RSL is estimated to occur in 1.5 percent of the adult population in Japan, with most patients over the age of 40, and with a high prevalence in women in particular.. RLS affects the quality of life of over two million patients, yet in most cases RLS is misdiagnosed as insomnia or some other condition because RLS is still a relatively unknown disorder. As a result, many patients are insufficiently treated.

RLS, which primarily manifests in the legs (calves, thighs, and feet) as an abnormal sensation, is a chronic disorder which can make the patient unable to sit or stay still. How the abnormal sensation is expressed varies widely from patient to patient, with complaints such as restlessness, itchiness, burning, or pain inside or along the legs. The symptoms worsen at rest, when sitting or lying down, and are often particularly severe before bedtime, preventing the onset of sleep. The symptoms can also appear during daytime, for example during sedentary periods such as business meetings. Treatments with a constant and continuous efficacy in suppressing the symptoms of RLS throughout the day have been long awaited.