NTC SRL

MILAN, Dec. 5, 2024 /PRNewswire/ -- NTC, an international R&D focused pharmaceutical company headquartered in Italy, presents positive results from Phase II MIRAKLE study, a multicentre, randomized, blinded-assessor, phase II non-inferiority study evaluating the efficacy and tolerability of NTC014 (quinolone antibiotic + NSAID in eye drops solution) in the treatment of bacterial conjunctivitis in adults. Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator –25% of less antibiotic administered - the main results showed the non-inferiority of NTC014 eye drops vs antibiotic alone in microbiological eradication, with unexpected efficacy results even against pathogens classified as Intermediate or Resistant to the quinolone antibiotic under study. "These interim findings reaffirm that NTC014 is eligible to be a new treatment for bacterial conjunctivitis", Alessandro Colombo, Chief Scientific Officer, NTC, states. "We aim at demonstrating with robust clinical evidence value and potential for NTC014, considering also that this drug responds to our mission to contribute to fighting antibiotic resistance by using less antibiotics, for a shorter treatment duration with no limitation of usage, also in case of non-confirmation of bacterial etiology." "We are encouraged by the overall results of the Mirakle study", says Riccardo Carbucicchio, Chief Executive Officer in NTC, "NTC 014 is first in class combination worldwide of an antibiotic and an NSAID. Given the significant unmet medical need, NTC014 aims to provide physicians with an effective treatment for moderate-severe bacterial conjunctivitis, a common eye infection. We believe that NTC 014 has a great potential and we aim to finalize the commercial partnering for this asset in most countries of the world before end of 2025. We do not exclude to develop this asset for surgical use too". Conjunctivitis is a common disease in Western Countries and imposes economic and social burdens. Viral conjunctivitis is the most common cause of infectious conjunctivitis both overall and in the adult population, bacterial conjunctivitis is the second most common cause and is responsible for the majority (50%-75%) of cases in children. NTC has already successfully developed and launched the first combination of a quinolone and steroid for post cataract surgery1, licensed in almost 90 countries and currently marketed in 60 countries, in Europe, Asia, Americas and Africa. About NTC A pharmaceutical company headquartered in Milan - Italy, with distributors and partners in more than 100 countries, engaged in research, development, registration, and commercialization of drugs, medical devices, and food supplements in ophthalmology, and other therapeutic areas including pediatrics, gynecology, and gastroenterology. NTC offers more than 200 partners innovative and high quality standard pharmaceutical products. For more information, please visit 1. Bandello F., et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (2020), Logo - SOURCE NTC Srl WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

米兰 2024年12月5日 /美通社/ -- 总部位于意大利的国际研发型制药公司NTC呈现了II期MIRAKLE研究的阳性结果，这是一项 多中心、随机、盲态评估、II期非劣效性研究， 评估NTC014 （喹诺酮类抗生素+滴眼液中的NSAID ）治疗成人细菌性结膜炎的有效性和耐受性。 尽管NTC014由于其简化的治疗方案，其给药剂量低于抗生素对照剂–25%的抗生素用量-但主要结果显示， NTC014滴眼液在 微生物根除方面优于单用抗生素，即使对被研究喹诺酮类抗生素中间体或耐药的病原体也有意想不到的疗效。 NTC首席科学官 Alessandro Colombo 表示： “这些中期研究结果重申， NTC014有资格成为细菌性结膜炎的新疗法。 “我们的目标是以强有力的临床证据证明NTC014的价值和潜力，同时考虑到这种药物响应了我们的使命，即通过使用更少的抗生素来对抗抗生素耐药性，在更短的治疗时间内不受使用限制，在细菌病因未得到证实的情况下也是如此。” NTC首席执行官Riccardo Carbucicchio 表示： “我们对Mirakle研究的整体结果感到鼓舞， NTC 014是全球首个抗生素和非甾体抗炎药的组合。 鉴于显着未满足的医疗需求， NTC014旨在为医生提供中重度细菌性结膜炎（一种常见的眼部感染）的有效治疗。 我们相信NTC 014具有巨大的潜力，我们的目标是在2025年底之前在世界大多数国家完成该资产的商业合作伙伴关系。 我们也不排除开发此资产用于外科手术。” 结膜炎是西方国家的常见疾病，带来经济和社会负担。 病毒性结膜炎是整体和成人感染性结膜炎的最常见原因，细菌性结膜炎是第二常见原因，是儿童感染性结膜炎的大部分原因（ 50% -75% ）。 NTC已经成功开发并推出了用于白内障后手术的喹诺酮和类固醇的首个组合 1 ，在近90个国家获得许可，目前在欧洲、亚洲、美洲和非洲的60个国家销售。 关于NTC 一家总部位于意大利米兰的制药公司，在100多个国家\/地区拥有分销商和合作伙伴，从事眼科以及儿科、妇科和胃肠病学等其他治疗领域的药物、医疗器械和食品补充剂的研究、开发、注册和商业化。 NTC为200多个合作伙伴提供创新的高质量标准药品。 如需了解更多信息，请访问 www.ntcpharma.com 1.   Bandello F., et al.用于白内障手术的一周左氧氟沙星加地塞米松滴眼液：一种创新的合理治疗策略。 Eye （ 2020 ） ， https:\/\/doi.org\/10.1038\/s41433-020-0869-1

MILAN, May 30, 2024 /PRNewswire/ -- NTC, an International pharmaceutical company with headquarter in Italy, with a specific focus in ophthalmology and with a significant portfolio in gynecology and gastroenterology too, continues in its certification path and receives the fifth Medical Device Regulation (MDR) Certificate approval, this time for its hypertonic ophthalmic solution based on NaCl 5% multidose. Continue Reading RICCARDO CARBUCICCHIO, CEO NTC started back in 2018 its activity plan to successfully carry its 32 Technical files of medical devices - representing north of 200 SKUs in Europe only - from the EU directive to Medical Device Regulation 2017/745 (MDR). "To build a strong foundation and unleash sustainable growth in the future", states Riccardo Carbucicchio CEO of NTC, "we have proactively moved ahead already time ago and begun working towards meeting MDR requirements and obtaining CE marks renewals for our medical devices, according to the new EU regulation, before the deadlines. In this way, we have been trying and keep trying to secure our portfolio and give long term continuity to the agreements in place with our customers, for the benefits of many patients in the many countries where our products are marketed." MDR intends to secure effective and safe medical devices, adequately documented, to the markets and set new standards for clinical trials too. Besides this, it provides a regulatory framework, supporting innovation and competitiveness of the medical device industry in the EU. Silvia Regondi, Chief Operating Officer of NTC says: "The partnerships with our contract manufacturing organizations together with the expertise of our R&D, Quality, and Regulatory departments are enabling us to sustain our innovative therapeutic solutions meant to satisfy unmet medical needs for patients in Europe and beyond. We are following very respectfully the feedback we are receiving from regulatory bodies during the registration path. " NTC adds another brick to its credibility delivering good quality files, in the context of this very important transformation in the medical device regulation in Europe. About NTC A pharmaceutical company headquartered in Milan - Italy, with distributors and partners in more than 100 countries, engaged in research, development, registration and commercialization of drugs, medical devices and food supplements in ophthalmology, and in other therapeutic areas including pediatrics, gynecology and gastroenterology. NTC offers to more than 200 partners innovative and high quality standard pharmaceutical products. For more information, please visit Photo - Logo -