治疗精神分裂症药物“Abilify(R)”将于6月8日开始在日本销售

治疗精神分裂症药物“Abilify(R)”将于6月8日开始在日本销售
www.med8th.com | 2006年6月9日

(BW)(OTSUKA-PHARMACEUTICAL)治疗精神分裂症具有新作用机理的抗精神病药物“Abilify(R)”将于6月8日开始在日本销售

美国商业新闻2006年6月6日东京消息——Otsuka Pharmaceutical Co., Ltd.（OPC；总部：日本东京Chiyoda-ku；总裁：Tatsuo Higuchi；电话：+81-3-3292-0021）宣布于6月8日推出一种非典型抗精神病药物Abilify(R)（开发代码：OPC-14597，非专有名称：aripiprazole）。

Abilify是一种具有新的作用机理的抗精神病药物，这种作用机理于1988年被OPC公司发现，并加以开发。Abilify于2002年11月作为治疗精神分裂症药物在美国获得上市批准，目前，该药物已在包括欧洲（1）在内的超过45个国家和地区销售。

日本国际医疗福祉大学（International University of Health and Welfare）教授Kunitoshi Kamijima博士对Abilify的获准上市发表评论说：“五年来第一个具有前途的新药问世了。半个多世纪来，抗精神病药物一直是治疗精神分裂症的一种行之有效的方法。不过，患者和医师一直对这种药物在治疗过程中所产生的负作用感到不安。这些负作用包括肌肉僵化、手指颤抖、面部肌肉就像带了一副面具一样毫无表情等等，这些都属于锥体束外综合症症状。这些不良反应扰乱了患者的正常生活，给他们走向社会设置了很大的障碍，严重影响了他们的生活质量。临床医师对Abilify寄予了很高的期望，它通过多巴胺部分激动剂扩展了治疗精神分裂症的途径。”

日本全国精神障碍者家庭联合会（National Federation of Families with the Mentally Ill）主席Masayasu Komatsu先生对Abilify在日本发布充满了希望。他说：“我们曾积极推动那些已在国外使用并证明有很好疗效，而在日本还没有上市药物的早期应用。我们唯一的愿望就是让患者能够减轻精神分裂症所带来的痛苦。由于抗精神病药物的治疗效果因人而异，我们欢迎使用Abilify作为治疗精神分裂症的一种新选择。”

总裁Higuchi评论说：“我们对Otsuka公司推出Abilify，并把它开发成一种在治疗精神分裂症上取得重要进步的药物而感到非常自豪。迄今为止，Abilify作为一种国际化药品已经进行战略性的市场推广。Abilify现在可以为其发源地日本的病人所使用，我们对此感到非常高兴。Abilify可以帮助日本那些饱受精神分裂症之苦的患者创造更加美好的生活。预计，这种药物将会成为一种具有很高价值的治疗选择。”

Abilify是一种具有新的作用机理的抗精神病药物，这是作为多巴胺D2受体部分兴奋剂产生治疗作用的，从这点来说它与其他抗精神病药物有所不同。它会在大量多巴胺在脑部释放的时候表现出抑制作用，而当仅有少量多巴胺释放时它又会表现出刺激作用。正式由于具有这种作用机理， Abilify以多巴胺系统稳定剂（DSS）而闻名。它可以改善被认为是由多巴胺异常引起的精神分裂症阳性症状和阴性症状。由于这种药物极少引起嗜睡或体重增加的现象，预计Abilify可被长期使用。

精神分裂症是最常见的一种慢性衰弱性精神疾病，有近1%的人口终生患有此病。精神分裂症扰乱了患者的正常社会生活，包括清晰思维、情绪控制、决策以及人际关系。这种疾病常见于刚步入成年的人群，其阳性症状的主要表现为产生幻想和错觉，而阴性症状的主要表现为冷漠、缺少人际交往、缺乏激情。

（1）：Otsuka公司（包括其子公司）具有在日本、中国、台湾、韩国、菲律宾、泰国、印度尼西亚、巴基斯坦和埃及的Abilify独有营销权，目前营销活动已在台湾、韩国、菲律宾、泰国、印度尼西亚和埃及展开。在美国和欧洲，Otsuka公司拥有许可和营销Abilify的权利，在美国和4个欧盟国家（英国、法国、德国和西班牙），OPC公司的本地子公司和Bristol-Myers Squibb Company共同营销Abilify。在其他Abilify获得批准上市的国家，由Bristol-Myers Squibb负责该药物的营销。

Otsuka Pharmaceutical Co., Ltd.是一家成立于1964年的保健公司。Otsuka公司的宗旨是：“Otsuka——为全人类的身体健康创造新产品”。Otsuka公司研究、开发、生产和营销创新的原创产品，其核心业务主要集中于治病的药品及日常保健品。

Otsuka Pharmaceutical Group由87家子公司组成，在全球17个国家和地区拥有近2.7万名员工。2005财年，Otsuka公司及浜喜⒆庸镜哪晔杖氪锏搅?8亿美元。

Abilify产品摘要（仅适用于日本）

产品名称：Abilify 3 mg 药片、Abilify 6mg 药片、Abilify1%粉末

治疗类别：抗精神病药物（阿立哌唑配制品）

非专有名称：Aripiprazole

适应症：精神分裂症

用量与用法：成人普通用量为每天6－12毫克，作为阿立哌唑的维持剂量为每天6－24毫克，每天一次或每天分两次口服。用量根据患者的年龄及症状不同可进行适当调整，但每天用量不得越过30毫克。

批准日期：2006年1月23日

列在NHI药品价格目录上的日期：2006年6月1日

请访问Otsuka Pharmaceutical Co., Ltd.网站 http://www.otsuka-global.com 。

联系方式：Otsuka Pharmaceutical Co., Ltd. Hideki Shirai, +81-3-3292-0021 siraih@otsuka.jp

(BW)(OTSUKA-PHARMACEUTICAL) Drug to Treat Schizophrenia With a New Mechanism of Action, Antipsychotic Agent ''Abilify(R)'' Available in Japan From June 8

TOKYO--(BUSINESS WIRE)--June 6, 2006--

Otsuka Pharmaceutical Co., Ltd. (OPC; Head Office: Chiyoda-ku, Tokyo, Japan; President: Tatsuo Higuchi; Phone: +81-3-3292-0021) announces the launch of an atypical antipsychotic agent, Abilify(R) (development code: OPC-14597, nonproprietary name: aripiprazole), on June 8.

Abilify is an antipsychotic medication with a new mechanism of action that was discovered in 1988 and developed by OPC. Abilify was approved for marketing in the United States as a treatment for schizophrenia in November 2002 and is currently marketed in more than 45 countries and regions including Europe(1).

Dr. Kunitoshi Kamijima, professor of the International University of Health and Welfare, commented about the approval of Abilify, saying that "For the first time in five years, a promising new drug has appeared. For more than half a century, antipsychotics have provided an effective means for the treatment of schizophrenia. However, both patients and physicians have continued to be distressed by adverse reactions such as muscle rigidity, finger tremors and mask-like facial expressions that are due to extrapyramidal symptoms. These adverse reactions can disturb living activities, make returning to society difficult and affect patients' quality of life. Clinicians have high expectations for Abilify, with dopamine partial agonist action, which broadens the options for the treatment of schizophrenia."

Mr. Masayasu Komatsu, chairman of the National Federation of Families with the Mentally Ill in Japan, is hopeful about the launch of Abilify in Japan. "We have actively promoted the early introduction of drugs which have been used overseas and have shown valid evidence of effectiveness, but are not yet available in Japan," he said. "Our only wish is that the patients get relief from the pain of schizophrenia. Since the effectiveness of antipsychotic drugs differs from person to person, we welcome the introduction of Abilify, which represents a new option for the treatment of schizophrenia."

President Higuchi commented, "We are proud that Otsuka discovered Abilify and developed it as a drug that has made important advances in the treatment of schizophrenia. To date, Abilify has been strategically marketed as an international product around the world, and we are very pleased that Abilify is now available to patients in Japan, the country of its birth. Abilify may help people in Japan who suffer from schizophrenia lead more productive lives. It is expected to become a valuable new treatment option."

Abilify is an antipsychotic drug with a new mechanism of action; it works as a partial agonist against dopamine D2 receptors and differs from other antipsychotics in this respect. It shows inhibitory action when large amounts of dopamine are released in the brain and stimulatory action when only small amounts of dopamine are released. Because of this mechanism of action, Abilify is known as a dopamine system stabilizer (DSS). Therefore, it improves both positive and negative symptoms of schizophrenia considered to be caused by dopamine abnormalities. It is expected that this drug can be used for long periods since it is considered that this drug is less likely to cause sleepiness or weight gain.

Schizophrenia is the most chronic and debilitating psychiatric disease, with a lifetime prevalence in approximately 1% of the population. Schizophrenia causes disturbances in social functions of the patients, including clear thinking, emotional control, decisiveness and interpersonal relations. The disease often appears in early adulthood and is characterized by positive symptoms such as hallucinations and delusions, and negative symptoms such as apathy, lack of interpersonal communications, and lack of drive.

(1): Otsuka (including its affiliates) has exclusive marketing rights for Abilify in Japan, China, Taiwan, Korea, the Philippines, Thailand, Indonesia, Pakistan and Egypt, and marketing has already started in Taiwan, Korea, the Philippines, Thailand, Indonesia and Egypt. In the United States and Europe, Otsuka holds approval and marketing rights for Abilify, and in the United States and 4 EU countries (UK, France, Germany and Spain), Abilify is co-marketed by the local subsidiaries of OPC and Bristol-Myers Squibb Company. In other countries where Abilify has received approval, it is marketed by Bristol-Myers Squibb.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka -- people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health.

The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US$6.8 billion in annual revenues in fiscal 2005.

Product summary of Abilify (for Japan only)

Product name : Abilify Tablets 3 mg, Abilify Tablets 6 mg, Abilify Powder 1%

Therapeutic category : Antipsychotic agent (aripiprazole preparation)

Nonproprietary name : Aripiprazole

Indication : Schizophrenia

Dosage and administration : The usual adult dosage starts with 6-12 mg/day, followed by a maintenance dose of 6-24 mg/day as aripiprazole, taken once a day or divided into two oral administrations per day. The dose may be adjusted according to the patient's age and symptoms but should not exceed 30 mg/day.

Approval date : January 23, 2006

Date of listing in : June 1, 2006 the NHI reimbursement price

Visit Otsuka Pharmaceutical Co., Ltd. at http://www.otsuka-global.com.

CONTACT: Otsuka Pharmaceutical Co., Ltd. Hideki Shirai, +81-3-3292-0021 siraih@otsuka.jp