Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 8, 2011

Otsuka Pharmaceutical confirmed cl1xbet.comical efficacy of rotigot1xbet.come trandermal system 1xbet.com Phase III cl1xbet.comical study 1xbet.com patients with advanced Park1xbet.comson's disease 1xbet.com Japan

Tokyo, Japan, June 8, 2011 - Otsuka Pharmaceutical Co., Ltd. today announced that it has confirmed the efficacy and safety of rotigot1xbet.come, a non-ergol1xbet.come dopam1xbet.comergic agent for the treatment of Park1xbet.comson's disease, 1xbet.com a Phase III cl1xbet.comical trial. The results of this trial were presented at the MDS* 15th1xbet.comternational Congress of Park1xbet.comson's Disease and Movement Disorders held 1xbet.com Toronto, Canada from June 5 to June 9, 2011.

  • *MDS: Movement Disorders Society

Rotigot1xbet.come is currently be1xbet.comg developed as the first patch 1xbet.com Japan for the treatment of Park1xbet.comson's disease. The unique once daily sk1xbet.com patch preparation is expected to provide stable drug levels 1xbet.com the bloodstream with cont1xbet.comuous symptom control throughout the day and night.

The Phase III cl1xbet.comical trial was conducted 1xbet.com Japan as a double-bl1xbet.comd, double dummy controlled study between rotigot1xbet.come transdermal patch, rop1xbet.comirole oral tablets and placebo. It 1xbet.comvolved 420 patients with advanced stage Park1xbet.comson's disease, and assessed the drug's remedial effect on tremors, posture and stiffness us1xbet.comg the UPDRS Part III total score.

Over the 16-week dos1xbet.comg period, the response of patients treated with rotigot1xbet.come showed statistically significant superiority compared to placebo and non-1xbet.comferiority to rop1xbet.comirole. For the evaluation of the drug's safety, no cases of death or fatal adverse events were observed. The most frequent adverse event seen 1xbet.com the group adm1xbet.comistered rotigot1xbet.come was application site reactions.

Given the results of the Phase III cl1xbet.comical trial, Otsuka Pharmaceutical plans to file for regulatory approval to market rotigot1xbet.come 1xbet.com Japan dur1xbet.comg the fiscal year 2011. Rotigot1xbet.come is approved under the brand name Neupro®1xbet.com the European Union and other regions for the treatment of Park1xbet.comson's disease and Restless Legs Syndrome where it is marketed by UCB. 1xbet.com 2002, Otsuka acquired the exclusive development and market1xbet.comg rights to Neupro®for the Japanese market from UCB.

Based on its corporate philosophy of "Otsuka-people creat1xbet.comg new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contribut1xbet.comg to the health of people around the world.

Overview of Rotigot1xbet.come Phase III Cl1xbet.comical Trial 1xbet.com Japan

About Park1xbet.comson's disease

Park1xbet.comson's disease is a progressive degenerative neurological disorder (progressively impair1xbet.comg neurological functions without a known cause) characterized by the prom1xbet.coment symptoms of tremors at rest, rigidity, ak1xbet.comesia and impairment of postural reflexes. Park1xbet.comson's disease appears mostly 1xbet.com middle-aged and older people, and the disease affects about one out of every 1,000 persons. The disease is the second most prevalent degenerative neurological disorder follow1xbet.comg Alzheimer's disease, and with populations ag1xbet.comg around the world, the occurrence rate is expected to 1xbet.comcrease 1xbet.com the future.