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Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD
Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD
The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s (OTCQB:TBPMF) (TSX:TBP) (FRA:JAM1) PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.
"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", stated Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra Bio-Pharma.
About PPP004
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of active pharmaceutical ingredients (APIs) that are manufactured as per good manufacturing practices requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.
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PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.
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PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment.
About epidermolysis bullosa
Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.
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The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s (OTCQB:TBPMF) (TSX:TBP) (FRA:JAM1) PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.
歐洲藥品管理局(EMA)已分類利樂生物製藥公司-歐洲™s(場外交易代碼：TBPMF)(多倫多證券交易所：TBP)(法蘭克福證券交易所：JAM1)PPP004作為治療大皰性表皮鬆解症的孤兒藥物(EB)。這是PPP004第三次指定孤兒藥物(ODD)作為EB的治療方法。
"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", stated Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra Bio-Pharma.
這一重要的稱號是PPP004發展過程中的一個里程碑，因為利樂繼續在歐洲執行其監管戰略。它也突顯了為EB患者提供有效治療選擇的迫切需要蓋伊·錢伯蘭博士利樂生物製藥公司首席執行官兼首席監管官。
About PPP004
關於PPP004
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of active pharmaceutical ingredients (APIs) that are manufactured as per good manufacturing practices requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.
PPP004是一種局部製劑，含有標準量的CBD或定義的THC和CBD的比例。基礎產品是一種專有的藥劑級配方，由根據良好生產實踐要求生產的活性藥物成分(原料藥)和被歸類為GRAS(通常被認為是安全的)的輔料組成。奶油將包裝在計量劑量的無氣泵系統中，設計用於在每次致動時始終如一地提供測量劑量的原料藥，並保護原料藥免受已知的降解來源，即光和氧氣的影響。PPP004是為了幫助EB患者控制疼痛和瘙癢並促進傷口癒合而開發的。
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PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.
-
PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.
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僅含CBD的PPP004已被美國FDA和EMA批准用於治療EB。
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含有THC和CBD組合的PPP004已被美國FDA批准用於治療EB。
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment.
EMA孤兒藥物名稱授予旨在治療、預防或診斷危及生命或慢性衰弱的疾病或疾病的研究療法，這些疾病或條件影響到歐盟每10,000人中不到5人。ODD帶來了幾個獨特的優勢，從藥物開發成本的降低，到加速審查過程和10年的市場排他性。這樣的戰略具有成本和時間效益，並使公司能夠在競爭激烈的自由環境中輕鬆獲得市場份額。
About epidermolysis bullosa
關於e皮膚鬆解症b尺骨
Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.
大皰性表皮鬆解症是一種罕見的疾病，會導致皮膚和粘膜起泡。水泡發生時會有輕微的創傷或摩擦，而且會很痛。其嚴重程度從輕微到致命不等。大皰性表皮鬆解症無法治癒，儘管輕微的形式可能會隨着年齡的增長而改善。治療的重點是照顧水泡和防止新的水泡。
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利樂生物製藥公司獲得加拿大衞生部批准在吸入性大麻二醇安全研究中使用100毫克CBD
Tetra Bio-Pharma Signs License Agreement With Thorne Health Tech For A Prebiotic Dietary Supplement
利樂生物製藥公司與Thorne Health Tech簽署益生元膳食補充劑許可協議
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國，moomoo上的投資產品和服務由Moomoo Financial Inc.提供，一家受美國證券交易委員會（SEC）監管的持牌主體。 Moomoo Financial Inc.是金融業監管局（FINRA）和證券投資者保護公司（SIPC）的成員。
在新加坡，moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供，該公司受新加坡金融管理局（MAS）監管(牌照號碼︰CMS101000) ，持有資本市場服務牌照 (CMS) ，持有財務顧問豁免（Exempt Financial Adviser）資質。本內容未經新加坡金融管理局的審查。
在澳大利亞，moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供，該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構（AFSL No. 224663）。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件，這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大，透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供，並受加拿大投資監管機構（CIRO）監管。
在馬來西亞，moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供，該公司受馬來西亞證券監督委員會（SC）監管(牌照號碼︰eCMSL/A0397/2024) ，持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.，Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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