RARE Daily

Castle Creek Acquires Fibrocell for Gene Therapies to Treat Rare Skin Disorders

September 13, 2019

Castle Creek Pharmaceutical Holdings, the parent of Castle Creek Pharmaceuticals, has reached an agreement to acquire Fibrocell Science, a cell and gene therapy company developing treatments for skin and connective tissue diseases.

Photo: Greg Wujek, CEO of Castle Creek Pharmaceuticals

Under the terms of the deal, Castle Creek will pay Fibrocell shareholders $3 per share, a 63 percent premium to its 30-day volume all-cash price for a total consideration of approximately $63.3 million, including repayment of debt and other financial instruments, in cash. The deal is expected to close in the fourth quarter of 2019 with Fibrocell becoming a privately held subsidiary of Castle Creek Pharmaceutical Holdings.

Castle Creek Pharmaceuticals says Fibrocell’s pipeline will augment its late-stage topical ointment under development for the treatment of epidermolysis bullosa simplex, a group of rare genetic skin conditions that cause the skin to blister and tear with minimal contact.

“Following our licensing agreement to develop and commercialize FCX-007, our experience working together on rare dermatological conditions caused us to quickly realize that Castle Creek and Fibrocell could achieve even greater synergies by combining the companies into one,” said Greg Wujek, CEO of Castle Creek Pharmaceuticals. “With Castle Creek’s resources, Fibrocell’s gene therapy platform can be advanced into additional areas of high, unmet need – with the potential to develop multiple promising new therapies.”

Fibrocell’s portfolio includes FCX-007, an experimental, late-stage stage gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare congenital and progressive skin disease caused by the deficiency of the protein COL7. RDEB is life-threatening with no approved cure or treatment.

FCX-007 is a genetically modified autologous fibroblast that encodes the gene for COL7. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution. A pivotal phase 3 clinical trial was initiated in late July 2019, and if successful, a Biologics License Application (BLA) filing is expected in 2021.

The portfolio also includes FCX-013, an experimental gene therapy candidate for the treatment of moderate to severe localized scleroderma. FCX-013 is an autologous fibroblast genetically modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 is currently enrolling for the first portion of a phase 1/2 clinical trial.

FCX-007 and FCX-013 have both been granted Orphan Drug designation, Rare Pediatric Disease designation, and Fast Track designation by the U.S. Food and Drug Administration. FCX-007 has also been granted Regenerative Medicine Advanced Therapy designation by the FDA.

“We believe that combining with Castle Creek has a strong strategic rationale, as they have the expertise and resources necessary to continue the development of both FCX-007 and FCX-013, potentially bringing these and additional novel products to patients in need, said John Maslowski, president and CEO of Fibrocell.

Author: Rare Daily Staff

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