Alprostadil

精彩内容 日前，国家药监局官网显示，石药集团中诺药业申报的4类仿制药注射用两性霉素B脂质体获批生产并视同过评，为国产第2家获批并首家视同过评。这是一款多烯类抗真菌药，2024一季度在重点省市公立医院终端的销售额增速超过190%。 注射用两性霉素B脂质体是内含两性霉素B的双层脂质体，与普通注射剂相比，可减少药物肾毒性、输液反应，提高治疗指数。其有效成分两性霉素B属于多烯类抗生素，用于治疗敏感真菌引起的系统性真菌感染、不明原因发热且高度提示存在系统性真菌感染的中性粒细胞减少症患者、内脏利什曼病等。 米内网数据显示，2023年重点省市公立医院终端注射用两性霉素B脂质体的销售额增速超过65%，2024第一季度继续以超190%的增速继续放量，市场潜力可期。 近年来重点省市公立医院注射用两性霉素B脂质体销售情况（单位：万元） 来源：米内网重点省市公立医院药品终端竞争格局 目前国内拥有注射用两性霉素B脂质体生产批文的国内企业仅上海上药新亚药业、石药集团中诺药业2家，其中石药集团中诺药业的产品视同过评，为国内首家；此外，江西艾施特制药、北京泰德制药、Taiwan Liposome等企业的产品以新注册分类报产，目前还在审评审批中。 脂质体技术具有提高药物稳定性、降低药物毒性、提高药物疗效等优势。目前国内已有多款脂质体产品获批上市，盐酸多柔比星脂质体注射液、注射用紫杉醇脂质体已成长为超10亿大品种，其中盐酸多柔比星脂质体注射液2023年在中国三大终端六大市场的销售额超过43亿元。 目前，石药集团已有注射用两性霉素B脂质体、盐酸伊立替康脂质体注射液、盐酸米托蒽醌脂质体注射液、盐酸多柔比星脂质体注射液等多款脂质体产品获批上市；此外，注射用柔红霉素阿糖胞苷脂质体、注射用前列地尔脂质体、注射用紫杉醇阳离子脂质体等在开展临床试验。 今年以来，石药集团有8个品种获批生产并视同过评，分别为达格列净片、奥拉帕利片、注射用右雷佐生、罗沙司他胶囊（首仿）、哌柏西利片（首仿）、帕拉米韦注射液、阿瑞匹坦注射液、注射用两性霉素B脂质体（首家过评）。 资料来源：米内网数据库、国家药监局官网等 注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库。数据统计截至9月19日，如有疏漏，欢迎指正。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

CRANBURY, N.J., June 20, 2024. Palatin Technologies, Inc., a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy. Topline data from the Phase 2 clinical study is expected by the end of calendar year 2024. "Approximately 30-40% of ED patients exhibit little or no response to PDE5i monotherapy, such as Viagra, Cialis, and Levitra," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "These PDE5i monotherapy drugs account for over $4 billion of annual sales, yet PDE5i monotherapy does not work for a significant portion of ED patients. This represents a substantial unmet medical need for more effective ED treatments. Based on our clinical data and mechanisms of action research, we believe that BMT combined with a PDE5i is synergistic and will be a clinically meaningful ED treatment for non-responders to current PDE5i monotherapy." The Phase 2 clinical trial is designed to enroll approximately 50 patients to be treated with BMT co-administered with a PDE5i in an open-label, dose escalation study treating men with ED who are considered non-responders to PDE5i monotherapy treatment. The clinical study is being conducted under an investigator-sponsored Investigational New Drug (IND) and has Food and Drug Administration (FDA) clearance and Institutional Review Board (IRB) approval. The study's primary objective is to assess the safety and efficacy of BMT co-administered with a PDE5i for the treatment of ED in males who have not adequately responded to prior PDE5i monotherapy. "ED has become more prominent over the last several decades, especially in younger adults, and represents a mounting health concern causing a significant effect on men's quality of life," said Jed Kaminetsky, MD, FACS, Urologist, Director of Research, Integrated Medical Professionals, a Division of Solaris Health and the clinical study lead investigator. "Many patients in my practice are seeking better results from their ED treatment. Men with more severe ED do not respond as well using a PDE5i and have limited non-surgical options. I have used bremelanotide in my practice for men with ED. I believe the combination of bremelanotide with a PDE5i could potentially be an effective treatment option for the PDE5i non-responders suffering from ED." Palatin has conducted multiple clinical studies of monotherapy BMT and combination therapy BMT plus a PDE5i in men with ED and observed statistically significant and clinically meaningful effects on improving erectile function. In addition, sub-cutaneous bremelanotide 1.75 mg (Vyleesi) is approved by the FDA for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women and has demonstrated an increase in sexual desire and decrease in distress associated with low desire. Palatin has developed a new co-formulation of bremelanotide and a PDE5i which can be administered as a single injection. An IND for this novel co-formulation for the treatment of ED is expected to be filed with the FDA later this calendar year and a potential Phase 3 clinical study in ED patients who do not respond to PDE5i monotherapy is expected to start in the first half of calendar year 2025. About Erectile Dysfunction (ED) Erectile dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse and affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention. Approximately 30-40% of men are non-responsive to standard therapies with phosphodiesterase-5 inhibitors (PDE5i) such as sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis). There are limited therapeutic options for ED patients non-responsive to PDE5i therapy, including alprostadil for direct penis injection or urethral suppositories, surgical penile implants and various devices. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. SOURCE Palatin Technologies, Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.