Phase III programme for alicaforsen enema in the orphan disease pouchitis

alicaforsen 灌肠治疗孤儿病贮袋炎的 III 期项目

• 批准号: 101453
• 金额: $ 240.9万
• 依托单位: ATLANTIC HEALTHCARE LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2013
• 资助国家: 英国
• 起止时间: 2013 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=101453
• 关键词: Phase; III; programme; alicaforsen; enema

Atlantic Healthcare is focused on the development and commercialisation of niche profitable specialist drugs meeting unmet clinical needs of patients managed in the hospital and specialist care environments in Europe and the US, neglected by larger international pharmaceutical companies. Alicaforsen, Atlantic's first product, is a novel ICAM-1 inhibitor and a first in class drug for the treatment of Inflammatory Bowel Disease (IBD). This is a $3.5bn pa market growing at 10% pa, driven by the need for new & effective therapies. Alicaforsen has completed Ph2 development and been granted orphan designation and a letter of fast track for Europe and the US for the treatment of pouchitis, a rare disease for which there is no approved treatment. Atlantic Healthcare has obtained agreement from international regulators that only a small single pivotal placebo controlled Ph3 is necessary for marketing approval for Europe/US.

Atlantic Healthcare专注于利基盈利的专科药物的开发和商业化，以满足欧洲和美国医院和专科护理环境中管理的患者未满足的临床需求，这些需求被大型国际制药公司所忽视。Alicaforsen是Atlantic的第一个产品，是一种新型ICAM-1抑制剂，也是治疗炎症性肠病（IBD）的第一种药物。这是一个35亿美元的PA市场，每年增长10%，这是由对新的有效疗法的需求驱动的。Alicaforsen已完成2期开发，并获得了孤儿药资格，并获得了欧洲和美国治疗结肠袋炎的快速通道证书，结肠袋炎是一种罕见疾病，目前尚无获批的治疗方法。Atlantic Healthcare已获得国际监管机构的同意，欧洲/美国上市批准仅需要一个小的关键安慰剂对照III期。