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Aradigm Announces Withdrawal of European Marketing Authorization Application (MAA) for Linhaliq

Aradigm Announces Withdrawal of European Marketing Authorization Application (MAA) for Linhaliq

阿拉迪格宣布撤回林哈利克的歐洲營銷授權申請(MAA)
Business Wire ·  2019/10/30 23:00

Aradigm Corporation (OTCQB: ARDMQ) (“Aradigm” or the “Company”) today announced that following a recent Oral Explanation, it has withdrawn its Marketing Authorization Application (MAA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa). The decision follows recent interactions with the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the CHMP was likely to formally adopt a negative opinion in its evaluation of the application.

阿瑞迪格姆股份有限公司 (OTCQB: ARDMQ) (」阿拉迪格姆」或「公司」) 今天宣布,經過最近的口頭解釋, 它已經撤回了其營銷授權申請 (MAA) 對於 Linhaliq 作為治療非囊性纖維化支氣管擴張 (NCFBE) 患者的慢性肺部感染與綠假單胞菌 (P. aeruginosa).該決定是根據最近與歐洲藥品管理局(EMA)人類用藥品委員會(CHMP)的互動,在此期間,公司得知 CHMP 很可能在評估該應用程序時正式採取負面意見。

On February 15, 2019, Aradigm filed a petition for bankruptcy protection under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Northern District of California, Case no. 19-40363. Information regarding Aradigm’s bankruptcy case and Aradigm’s Monthly Operating Reports may be obtained from the Bankruptcy Court. The Bankruptcy Court will hold a Status Conference in Aradigm’s bankruptcy case on November 6, 2019.

2019 年 2 月 15 日,Aradigm 根據《美國破產法》第 11 章向加利福尼亞北部地區破產法庭提交破產保護呈請書,案件編號 19-40363。有關 Aradigm 破產案和 Aradigm 每月營運報告的信息,可以從破產法院獲得。破產法院將於 2019 年 11 月 6 日在阿拉迪格姆的破產案中舉行狀態會議。

The Company has engaged Evergreen M&A Partners, LLC to facilitate the sale of substantially all of Aradigm’s assets, including its core intellectual property rights, and expects to secure initial bids for those assets within the next 30 to 60 days. Any final sale transaction will be subject to Bankruptcy Court review and approval following an auction process. The proceeds from the sale would be distributed to satisfy the claims of the Company’s creditors, also subject to Court approval. Remaining assets, if any, would then be distributed to the Company’s stockholders.

公司已與 Evergreen 併購合作夥伴有限責任公司合作,以促進 Aradigm 大部分資產(包括其核心智慧財產權)的銷售,並預計在未來 30 至 60 天內確保這些資產的初始競標。任何最終的銷售交易將在拍賣過程後進行破產法院審查和批准。出售所得的收益將分配,以滿足公司債權人的申索,並經法院批准。剩餘資產(如有)將分配給本公司的股東。

About Aradigm

關於阿拉迪格姆

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US) / Linhaliq (EMA). Aradigm is currently in Phase 3 development of Apulmiq/Linhaliq (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of patients with NCFBE and chronic lung infection withP. aeruginosa. Aradigm's inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.

Aradigm 是一家新興的專業製藥公司,專注於開發和商業化用於預防和治療嚴重呼吸系統疾病的藥物。阿拉迪格姆仍然有信心的有效性, 安全性和質量阿普爾米克 (美國)/林哈利克 (EMA).Aradigm 目前處於 Aulmiq/Linhaliq(環丙沙星用於吸入的研究專有製劑)用於治療 NCFBE 患者和慢性肺部感染的患者的第 3 階段。Aradigm 的吸入環丙沙星配方也是用於治療囊性纖維化和非結核分枝桿菌患者的候選產品,以及用於預防和治療高威脅和生物恐怖主義感染的候選產品,例如吸入 Tularemia,肺炎性瘟疫,類鼻病,Q 發熱和吸入性炭疽。

About Non-Cystic Fibrosis Bronchiectasis

關於非囊性纖維化支氣管擴張

Non-Cystic Fibrosis Bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

非囊性纖維化支氣管擴張(NCFBE)是一種嚴重,慢性和罕見疾病,其特徵是支氣管和支氣管異常擴張,頻繁 相關聯的 患有慢性肺部感染。這通常是炎症,復發性肺部感染和支氣管壁損傷的惡性循環的結果。NCFBE 代表著未滿足的醫療需求,具有高發病率和死亡率,影響了美國 15 萬多人和歐洲 20 萬人。目前沒有藥物批准用於治療這種情況.

Forward-Looking Statements

前瞻性陳述

Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the risk that Apulmiq/Linhaliq may not receive regulatory approval or be successfully commercialized, as well as the other risks detailed from time to time in the Company’s filings with the Securities Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 23, 2018, and the Company’s Quarterly Reports on Form 10-Q.

除本文所載的歷史資料外,本新聞稿包含涉及風險和不明朗因素的前瞻性陳述,包括 Aulmiq/Linhaliq 可能無法獲得監管批准或成功商業化的風險,以及在公司向證券交易委員會 (SEC) 提交的 2017 年 12 月 31 日表格中不時詳述的其他風險,包括公司截至 2017 年 12 月 31 日止的 10-K 表的年報。於二零一八年三月二十三日,以及本公司第 10-Q 表之季度業績報告。

More information about Aradigm can be found at www.aradigm.com.

有關阿拉迪格姆的更多信息可以在以下位置找到。

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation. Apulmiq and Linhaliq are registered trademarks of Grifols, S.A.

阿拉迪格姆和阿拉迪格姆標誌是阿瑞迪格姆公司的註冊商標。阿普爾米克和林哈利克是 Grifols 的註冊商標, S.A.

譯文內容由第三人軟體翻譯。


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