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

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

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

Shots:

  • 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

Click here to read full press release/ article | Ref: Fibrocell | Image: GetFilings

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post