BioVie Receives Notice Of Allowance For U.S. Patent Application Covering Novel Liquid Formulation Of Terlipressin
BioVie Receives Notice Of Allowance For U.S. Patent Application Covering Novel Liquid Formulation Of Terlipressin
The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie's liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US.Patents covering BioVie's terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets
涵盖BioVie特利压素液体配方的专利现已在美国、印度和智利获得，另外九个市场正在申请中
Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting
配方已证明室温稳定性长达 24 个月，这是在家庭护理环境中治疗肝硬化和腹水患者的重要优势
CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 17/611,478 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed.
内华达州卡森城，2024年10月1日（GLOBE NEWSWIRE）——BioVie Inc.（纳斯达克股票代码：BIVI）（“BioVie” 或 “公司”）是一家开发治疗神经系统和神经退行性疾病以及晚期肝病的创新药物疗法的临床阶段公司，今天宣布，它已收到美国专利商标局（USPTO）的许可通知第17/611,478号专利申请，题为 “特利加压素的配方”。一旦行政程序完成，这份许可通知预计将导致美国专利的签发。
The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie's liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US.
允许的索赔涵盖一种新的醋酸特利加压素液体配方，该配方在室温下具有两年的稳定性，可以包装在预先填充的注射器中。BioVie预计，由此产生的专利将获准在橙皮书中列出。该专利支持BioVie的特利加压素液体配方，用于为美国腹水和肝衰竭患者开发一种更加以患者为中心的门诊治疗方案。
Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications.
由于肝脏和肾脏功能不全，肝硬化和腹水患者腹部积聚了大量液体（通常超过5升）。进展为难治性腹水的患者一年存活率约为 50% 1。迄今为止，尚无经批准的专门治疗难治性腹水的药物疗法。这些患者的治疗以大容量穿刺术和TIPS等手术为基础，这些手术只能提供暂时的缓解，缺乏改善疾病的作用，并且经常会导致危及生命的并发症。