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Castle Creek Collaborates with Fibrocell to Develop and Commercialize FCX-007 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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Castle Creek Collaborates with Fibrocell to Develop and Commercialize FCX-007 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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  • Fibrocell to receive $7.5M upfront- $2.5M on first patient enrollment- $30M on BLA approval- $75M as commercial milestones and 30% of profit on product sales. Castle Creek to get an exclusive right to commercialize FCX-007 in the US and will responsible for its development and manufacturing expenses up to $20M prior to BLA filing to FDA
  • In case the development cost exceeds $20M- Fibrocell will pay 30% and rest 70% will be paid by Creek. Fibrocell to take care of clinical development- regulatory interaction- and manufacturing of the product under supply agreement with Creek and will retain rights to the eligible rare pediatric disease priority review voucher
  • Fibrocell's FCX-007 is a gene therapy encoding type VII collagen (COL7) and will be evaluated in P-III DEFI-RDEB study enrolling 15-20 patients with its expected initiation in Q2’19. FCX-007 is developed in collaboration with Intrexon Corporation

Ref: Fibrocell | Image: GetFilings

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