Microsoft Word _ アコファイド新発売
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1 各 位 2013 年 6 月 5 日 会社名ゼリア新薬工業株式会社代表者名代表取締役社長伊部幸顕 ( コード番号 4559 東証第一部 ) 問合せ先常務取締役広報部長森山茂 (TEL ) 会社名アステラス製薬株式会社代表者名代表取締役社長畑中好彦 ( コード番号 4503 東証 大証各第一部 ) 問合せ先広報部長河村真 (TEL ) 機能性ディスペプシア治療剤 アコファイド 錠 100mg 新発売のお知らせ ゼリア新薬工業株式会社 ( 本社 : 東京都中央区 代表取締役社長 : 伊部幸顕 以下 ゼリア新薬 ) とアステラス製薬株式会社 ( 本社 : 東京都中央区 代表取締役社長 : 畑中好彦 以下 アステラス製薬 ) は 機能性ディスペプシア治療剤 アコファイド 錠 100mg ( 以下 アコファイド 錠 一般名 : アコチアミド塩酸塩水和物 ) について 2013 年 6 月 6 日に新発売いたしますのでお知らせいたします 機能性消化器疾患の国際的診断基準であるローマⅢ 基準で診断された機能性ディスペプシア患者を対象に有効性を証明した世界初の機能性ディスペプシア治療剤として アコファイド 錠は世界に先駆けて日本で発売されることになります アコチアミド塩酸塩水和物は ゼリア新薬によって創製された新規化合物であり 消化管運動に重要な役割を果たす神経伝達物質アセチルコリンの分解酵素である末梢のアセチルコリンエステラーゼを阻害することにより 胃運動の低下および胃からの食物排出遅延を改善させ 機能性ディスペプシアの自覚症状のうち食後膨満感 上腹部膨満感 早期満腹感を改善します アコファイド 錠は機能性ディスペプシアを適応症とする初めての治療薬となることから 機能性ディスペプシアの疾患啓発や早期の市場構築 製品価値の最大化を図るために 両社で共同販促活動を行います アコファイド 錠は機能性ディスペプシアに苦しむ患者さんの自覚症状改善及び QOL 向上に貢献するものと期待しております なお 今回の新発売に伴うゼリア新薬およびアステラス製薬の当期 (2014 年 3 月期 ) 業績予想の変更はありません 1
2 アコファイド 錠 100mg の製品概要 [ 販売名 ] アコファイド 錠 100mg ( 英名 :Acofide Tablets 100mg ) [ 有効成分の一般名 ] アコチアミド塩酸塩水和物 ( 英名 :acotiamide hydrochloride hydrate ) [ 剤形 ] 錠剤 [ 効能 効果 ] 機能性ディスペプシアにおける食後膨満感 上腹部膨満感 早期満腹感 [ 用法 用量 ] 通常 成人にはアコチアミド塩酸塩水和物として 1 回 100mg を 1 日 3 回 食前に経口投与する [ 包装 ] PTP 100 錠 (10 錠 10) 500 錠 (10 錠 50) [ 薬価 ] 100mg 1 錠 円 [ 承認取得日 ] 2013 年 3 月 25 日 [ 薬価基準収載日 ] 2013 年 5 月 24 日 [ 販売開始日 ] 2013 年 6 月 6 日 [ 製造販売元 ] ゼリア新薬工業株式会社 [ 発売元 ] アステラス製薬株式会社 機能性ディスペプシアについて 機能性消化器疾患の国際的診断基準であるローマⅢ 基準によれば 食後の膨満感 早期満腹感 ( 飽満感 ) 心窩部痛 心窩部灼熱感などの消化器症状を訴えるが 原因となる器質的疾患が見当たらない疾患とされています 機能性ディスペプシアの原因は解明されていないものの 食物の胃から小腸への排出遅延が密接に関連していることが明らかとなっています 以上 2
3 PRESS RELEASE Launch of Acofide in Japan for Treating Functional Dyspepsia Tokyo, June 5, Zeria Pharmaceutical Co., Ltd. (Tokyo: 4559; Zeria ) and Astellas Pharma Inc. (Tokyo: 4503; Astellas ) announced today that Acofide Tablets 100mg (nonproprietary name: acotiamide hydrochloride hydrate; Acofide ; Zeria s development code: Z-338 ; Astellas s development code: YM443 ) for the treatment of functional dyspepsia (FD) will be launched on June 6, Acofide, the world first FD treatment which demonstrated efficacy in the patients with FD diagnosed by the Rome III, the international diagnostic criteria for functional gastrointestinal diseases, will be launched in Japan ahead of the rest of the world. Acotiamide hydrochloride hydrate is a new chemical entity originated by Zeria, and inhibits peripheral acetylcholinesterase activities. Acetylcholine is an important neurotransmitter to regulate gastrointestinal motility, and through the inhibition of degradation of acetylcholine, Acofide improves the impaired gastric motility and delayed gastric emptying, and consequently the subjective symptoms of FD such as postprandial fullness, upper abdominal bloating, and early satiation. Also, since Acofide will be the first treatment with FD indication, Zeria and Astellas will co-promote Acofide for the sake of the increase of disease awareness of FD, the prompt market penetration, and the maximization of product potential. We believe that Acofide will contribute to alleviate the subjective symptoms and improve QOL of patients with FD. Upon the launch of Acofide, Zeria and Astellas do not revise their current fiscal year (from April 1, 2013 to March 31, 2014) financial forecasts, respectively. 1
4 Product Summary Product name: Acofide Tablets 100mg Nonproprietary name: Acotiamide hydrochloride hydrate Formulation: Tablet Indication: Postprandial fullness, upper abdominal bloating, and early satiation due to functional dyspepsia Dosage regimen: Normally in adults, 100mg of acotiamide hydrochloride hydrate is taken orally three times per day before a meal. Package PTP 100 tablets (10 tablets X 10), 500 tablets (10 tablets X 50) Drug Price (per 100mg tablet) Date of approval March 25, 2013 Date of NHI price listing May 24, 2013 Date of launch June 6, 2013 Approval holder Zeria Pharmaceutical Co., Ltd. Distributor Astellas Pharma Inc. 2
5 About Functional Dyspepsia (FD) According to the Rome III, the international diagnostic criteria for functional gastrointestinal diseases, FD is a gastrointestinal disease comprised of subjective symptoms including postprandial fullness, early satiation, epigastric pain, and epigastric burning sensation without any organic abnormality on gastrointestinal tract. The etiology of FD is still unclear, but it has been shown that delayed gastric emptying is closely associated with FD. For inquiries or additional information Zeria Pharmaceutical Co., Ltd. Public Relations TEL: , FAX: Astellas Pharma Inc. Corporate Communications TEL: , FAX:
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Fig. 1 Chemical structure of TE-031 Code number: TE-031 Chemical name: (-) (3R, 4S, 5S, 6R, 7R, 9R, 11R, 12R, 13S, 14R)-4-[(2, 6-dideoxy-3-C-methyl-3-
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Reprint request: A CASE OF PRESENTED VARIOUS FUNCTIONAL DISTURBANCES AFTER AN INJURY Taketoshi NOGAKI, Nobusuke HOUCHI, Tomoko SUGIUCHI, Naohiko WATANABE and Hiroyuki ZUSHO Department of Otolaryngology,
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Title 出 産 に 関 わる 里 帰 りと 養 育 性 形 成 Author(s) 小 林, 由 希 子 ; 陳, 省 仁 Citation 北 海 道 大 学 大 学 院 教 育 学 研 究 院 紀 要, 106: 119-134 Issue Date 2008-12-18 DOI 10.14943/b.edu.106.119 Doc URLhttp://hdl.handle.net/2115/35078
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No. 19 January 19 2013 19 Regionalism at the 19 th National Assembly Elections Focusing on the Yeongnam and Honam Region Yasurou Mori As the biggest issue of contemporary politics at South Korea, there
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ICT Development of curriculum for improving of teachers ICT based on evaluation standards. Kazuhiko ISHIHARA Abstract Ministry of Education and Science announced Checklist of teacher s ICT in March,. All
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Key words : 7432-S, Oral cephem, Urinary tract infection Fig. 1. Chemical structure of 7432-S.
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2011 8 6 2011 5 7 [1] 1 2 i ii iii i 3 [2] 4 5 ii 6 7 iii 8 [3] 9 10 11 cf. Abstracts in English In terms of democracy, the patience and the kindness Tohoku people have shown will be dealt with as an exception.