Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Limited, and includes its subsidiaries or associate companies) and Israel-based Moebius Medical Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain.

Sun Pharma（路透社：Sun.BO，彭博社：SUNP IN，NSE：SUNPHARMA，BSE：524715，Sun Pharmaceutical Industries Limited，包括其子公司或联营公司）和以色列Moebius Medical Limited宣布，美国食品和药物管理局（FDA）已授予MM-II（DPPC和DMPC的大型脂质体）快速通道指定（FTD）用于治疗骨关节炎膝关节疼痛。

Planning for confirmatory Phase 3 clinical trials for MM- II is underway..

正在计划MM-II的验证性3期临床试验。。

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs in order to potentially bring important new medicines to patients earlier. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review..

FDA的快速通道计划旨在促进旨在治疗严重疾病的疗法的开发和加速审查，并解决未满足的医疗需求，以便尽早为患者带来重要的新药。除其他好处外，研究产品被授予FTD的公司有资格在临床开发过程中与FDA进行更频繁的互动，并可能加速批准和/或优先审查。。

“As we enter Phase 3 development, we are very encouraged by the FDA’s decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis,” said Marek Honczarenko, MD, PHD, Senior Vice President, Head Global Development at Sun Pharma..

Sun Pharma全球发展负责人高级副总裁、医学博士Marek Honczarenko说：“随着我们进入第三阶段的发展，我们对FDA决定授予MM-II快速通道称号感到非常鼓舞，并认识到它有可能满足骨关节炎患者未满足的医疗需求。”。。

Moshe Weinstein, CEO of Moebius Medical, added, “This Fast Track Designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released Phase 2b data, which showed MM- II’s potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.”.

Moebius Medical首席执行官Moshe Weinstein补充道：“这一快速通道指定将使FDA能够快速审查MM-II，是MM-II发展的重要里程碑，并且遵循我们最近发布的2b期数据，该数据显示MM-II有可能为骨关节炎膝关节疼痛患者提供有效和持久的治疗。”。