Fibrocell up 51% premarket on Castle Creek collaboration

Fibrocesll与Castle Creek合作开发基因治疗药物后,前期市场份额增加51%

2019-04-15 21:30:29 seekingalpha


标签: 医药/器械 行业监管/综合服务 医药 医疗合作 生物制药/生物制品 医药CRO/CMO/CDMO
Nano cap Fibrocell Science is up 51% premarket on robust volume in response to its collaboration with Castle Creek Pharmaceuticals to develop and commercialize gene therapy candidate FCX-007 for recessive dystrophic epidermolysis bullosa, a rare inherited disorder characterized by fragile blistering skin. Under the terms of the deal, Castle Creek will have an exclusive license to commercialize FCX-007 in the U.S. and will be responsible for all development and manufacturing costs up to $20M prior to the filing of a marketing application. If development spending exceeds $20M, Fibrocell will cover 30% of the excess expenses. Castle Creek will be responsible for all commercialization activities and costs while Fibrocell will maintain clinical development, regulatory interactions and manufacturing under a future supply agreement with Castle Creek. Fibrocell will receive $7.5M upfront, $2.5M when the first patient is enrolled in a Phase 3 study, $30M when the FDA approves the marketing application and market launch is ready, up to $75M in sales-based milestones, an additional $50M if sales reach $750M and 30% of gross profits. Fibrocell will retain sole ownership of the Rare Pediatric Disease Priority Review Voucher that it will receive on the FDA nod for FCX-007. A Phase 3 clinical trial, DEFI-RDEB, should launch this quarter.
Nano cap Fibrocesll Science 公司与 Castle Creek Pharmaceuticals 公司合作开发并商业化基因治疗候选药物 FCX-007,用于隐性营养不良的表皮松解性大疱,这是一种罕见的遗传性疾病,以脆弱的起泡皮肤为特征。 根据协议条款, Castle Creek 将获得在美国商业化 FCX-007的独家许可,并将在提交营销申请之前承担高达2000万美元的所有开发和制造成本。如果开发支出超过2000万美元, Fibrocesll 将承担30%的超额支出。Castle Creek 将负责所有商业化活动和成本, Fibrocesll 将根据未来与 Castle Creek 签订的供应协议,保持临床开发、监管互动和制造。 Fibrocesll 将会收到750万美元的前期费用,250万美元,当第一位患者被纳入第三阶段研究,3000万美元,当 FDA 批准营销申请和市场启动准备就绪,多达7500万美元的销售里程碑,如果销售达到7500万美元和30%的毛利,另外5000万美元。 Fibrocesll 将保留其在 FDA 批准 FCX-007时收到的罕见儿科疾病优先审查凭证的唯一所有权。 第三阶段临床试验, DEFI-RDEB ,应该在本季度启动。