Lanreotide Acetate

LUND, Sweden, April 25, 2025 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa®, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.1 "We are pleased with the CHMP's positive recommendation for market authorization for Oczyesa octreotide monthly depot for the treatment of acromegaly", says Fredrik Tiberg, President & CEO at Camurus. "Oczyesa has the potential to advance the standard of care for patients living with acromegaly by enhancing octreotide plasma exposure and enabling easy and convenient once-monthly self-administration by patients using an autoinjector pen." The CHMP positive opinion is backed by a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study showed improvements in symptoms, quality of life, and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at study baseline.2,3 The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.1 A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025. For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 [email protected] Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 [email protected] About acromegaly Acromegaly is a rare, progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.4 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.5,6 The prevalence of acromegaly is estimated to about 60 cases per million.7 About Oczyesa® (CAM2029) CAM2029 is a ready-to-use, long-acting subcutaneous depot of octreotide under development for the treatment of three chronic and severe disease indications: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.8 In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard-of-care (SoC) at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.2,3 CAM2029 is formulated using Camurus' proprietary FluidCrystal® technology. The product is designed for convenient once-monthly, subcutaneous self-administration using a pen with a hidden, small-gauge needle. The product is stored at room temperature and should not be refrigerated. CAM2029 has received orphan drug designation for acromegaly (EU) and for polycystic liver disease (EU and US). About Camurus Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund, Sweden. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit and LinkedIn. References Oczyesa® Summary of Opinion. Ferone, D., et al. J Clin Endocrinol Metab. Published 8 October, 2024. Press release 15 July, 2024: Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111. Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. Summary of Product Characteristics, Sandostatin LAR 20 mg: This information was submitted for publication at 4:00 pm CET on 25 April 2025. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

今日（4月25日），中国国家药监局（NMPA）官网最新公示，Recordati集团中国全资子公司锐康迪医药申报的注射用双羟萘酸帕瑞肽微球的上市申请已获得批准。根据NMPA药品审评中心（CDE）优先审评公示，该药本次获批用于治疗无法手术或手术后未治愈和通过另一种生长抑素类似物治疗控制不佳的成人肢端肥大症患者。公开资料显示，这是一款长效帕瑞肽产品（pasireotide pamoate）。此前，博鳌乐城维健罕见病临床医学中心已经引进该产品治疗肢端肥大症患者。截图来源：NMPA官网肢端肥大症是由生长激素（GH）和胰岛素样生长因子-1（IGF-1）分泌过多引起的一种罕见的、使人衰弱的内分泌疾病，该病已经在中国被纳入《第二批罕见病目录》。在大多数情况下，这种疾病是由脑垂体上的非癌性肿瘤引起的。长期暴露于生长激素和IGF-1可能会导致患者经历极端的身体变化，包括手、脚和面部特征的增大。肢端肥大症使患者死亡率增加2~3倍，并和严重的健康并发症有关，包括心脏病、高血压、糖尿病、关节炎和结肠癌。肢端肥大症治疗的总体目标是抑制GH过度分泌，降低IGF-1的水平，减少并发症，降低死亡率。长效帕瑞肽（即双羟萘酸帕瑞肽）为第二代生长抑素类似物（SRL），生长抑素正是GH分泌的生理抑制剂。与第一代SRL相比，长效帕瑞肽增强了生长抑素受体（SSTR） 的结合谱，即对SSTR1、2、3和SSTR5亚型具有高亲和力，尤其对SSTR5的亲和力最高，具有更好的临床和生化控制率，且安全性良好。对于不能选择手术或手术后尚未治愈，且使用第一代SRL治疗不能充分控制的成人肢端肥大症患者，长效帕瑞肽可以作为新的治疗选择。此前，双羟萘酸帕瑞肽已获得欧洲药品管理局（EMA）和美国FDA批准治疗成人肢端肥大症患者。根据文献报道，在一项3期PAOLA研究中，尽管入组患者在研究开始前接受了≥6个月的octreotide/lanreotide（活性对照）治疗，但肢端肥大症仍未得到控制。与继续使用活性对照药物治疗相比，更多的患者在使用长效帕瑞肽治疗6个月后达到了生化控制。在该核心研究结束时，接受40或60mg长效帕瑞肽治疗后生化指标受控的患者可以在延长期研究中继续使用相同剂量；如果未受控，则可接受60mg的长效帕瑞肽治疗。对于使用活性对照药物但未受控的患者，则切换为40mg的帕瑞肽治疗，如果在延长期研究的第16周仍未受控，则增加剂量。在延长期研究期间，共有173名患者接受了长效帕瑞肽治疗。结果显示，长效帕瑞肽的耐受性良好且疗效显著，能够长期维持肢端肥大症患者的生化控制并改善关键症状。长效帕瑞肽在长达5.8年的治疗期间有效且持续地降低了GH和IGF-I水平；37.0%的患者在核心或延长期研究内的某个时间点达到了GH <1.0 µg/L和正常IGF-I水平。参考资料：[1]2025年04月25日药品批准证明文件送达信息 . From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250425151104133.html[2]肢端肥大症患者治疗新选择！创新药长效帕瑞肽可在乐城申请使用 . Retrieved Oct 9， 2023. From https://mp.weixin.qq.com/s/6hJIqHK_P37So8FIRaJFNw[3]Recordati Rare Diseases, Inc. Announces Transfer of U.S. Marketing Rights to SIGNIFOR® (pasireotide) Injection and SIGNIFOR LAR® (pasireotide) for Injectable Suspension. Retrieved Feb 20， 2020. From https://www.recordatirarediseases.com/us/node/169[4] Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762. 版权声明：本文欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。