– Acquisition complements and expands Castle Creek clinical development pipeline to include gene therapy platform 

– Strategic acquisition to result in advancement of multiple late-stage investigational therapies for epidermolysis bullosa and other rare conditions 

Exton, PA., December 16, 2019 — Castle Creek Pharmaceutical Holdings, Inc. (“CCP Holdings”), a privately held company focused on developing medicine for important rare genetic disorders, today announced it has successfully completed the acquisition of Fibrocell Science, Inc., a cell and gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases. The combined organization is committed to advancing late-stage development programs in important rare genetic diseases such as epidermolysis bullosa (EB) and plans to target additional rare conditions with the gene therapy platform.

Both Castle Creek and Fibrocell have advanced investigational therapies for the treatment of EB into late-stage clinical research. EB is a rare genetic condition that leads to extremely fragile skin resulting in mild to severe blistering, skin erosion and peeling of the epidermis layers in response to minor injury. There are currently no treatment options approved by the U.S. Food & Drug Administration (FDA) for any form of EB.

“Our organizations have a shared commitment to delivering new treatment options to underserved communities such as EB patients and their families who have no approved therapies,” said Greg Wujek, chief executive officer of Castle Creek. “The addition of this late stage gene therapy will allow us to be the leader in rare genetic dermatology and additional genetic diseases as well.”

Prior to the acquisition, Fibrocell initiated a pivotal Phase 3 clinical trial evaluating a gene therapy candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA has granted Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, Rare Pediatric Disease and Fast Track designations to FCX-007. Castle Creek has also continued Phase 2b clinical research evaluating a diacerein topical ointment, CCP-020, for epidermolysis bullosa simplex (EBS) and other forms of EB. The FDA has designated the CCP-020 program for Fast Track development in the treatment of EBS.

Castle Creek is a portfolio company of Paragon Biosciences, which founded Castle Creek with the vision to deliver transformative therapies to patients with rare genetic dermatologic diseases.

About Castle Creek Pharmaceutical Holdings, Inc.
Castle Creek Pharmaceutical Holdings is a privately held holding company that holds and invests in companies in areas of unmet medical need such as rare genetic diseases.

About Castle Creek Pharmaceuticals, LLC

Castle Creek Pharmaceuticals is a privately held biopharmaceutical company developing innovative therapies for patients with rare and serious genetic diseases. The company, with offices currently in Basking Ridge, New Jersey and Chicago, Illinois, is dedicated to developing and bringing novel therapies to those living with epidermolysis bullosa. For more information, visit: https://www.castlecreekpharma.com/.

About Fibrocell
Fibrocell is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. Fibrocell is utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease. Fibrocell’s pipeline of localized gene therapy candidates include FCX-007 for the treatment of RDEB, a life-threatening genetic disorder diagnosed in infancy with no cure or treatment approved by the FDA. A pivotal Phase 3 clinical trial for FCX-007 was initiated in late July 2019. Fibrocell is also developing FCX-013 for the treatment of moderate to severe localized scleroderma and is currently enrolling the Phase 1 portion of a Phase 1/2 clinical trial. For more information, visit http://fibrocell.com/ or follow us on Twitter at @Fibrocell.

About Paragon Biosciences
Paragon is a life science innovator that invests in, builds, and advises bioscience companies. Our mission is to serve patients living with severe medical conditions which do not yet have adequate treatments. Paragon’s portfolio of independently-run bioscience companies focus on: biopharmaceuticals, AI-enabled life science products, and advanced treatments such as cell and gene therapies. We help people live longer, healthier lives. For more information, please visit: https://paragonbiosci.com/.

Media Contacts:

Adam Daley
Berry & Company Public Relations

Karen Casey

Jeff Winton

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