Fibrocell & Intrexon Announce Exclusive Channel Collaboration

Fibrocell Science, Inc. and Intrexon Corporation recently announced an Exclusive Channel Collaboration (ECC) for the development of genetically modified fibroblasts to treat chronic inflammatory and degenerative diseases of the joint, including arthritis and related conditions. According to the Centers for Disease Control and Prevention, arthritis—characterized by joint inflammation, pain, and decreased range of motion—is the United States’ most common cause of disability affecting more than 52 million adults as well as 300,000 children at a cost exceeding $120 billion.

“The synergy of our versatile fibroblast platform with Intrexon’s genetic engineering is readily apparent through two product candidates, FCX-007 and FCX-013, which have generated encouraging preclinical data across difficult-to-treat indications,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “We are excited by the expansion of our relationship with Intrexon and believe the power of our combined platforms will allow us to vie for leadership in this major therapeutic category and bring hope to patients and their families.”

Through the collaboration, Fibrocell’s proprietary fibroblast platform will be combined with Intrexon’s cellular engineering capabilities to generate cell-based therapeutics that have been modified to express one or more proteins at sites of joint inflammation helping overcome the limitations of existing treatment approaches for chronic inflammatory and degenerative diseases of the joint.

“With present standards of care focused on limiting symptoms and slowing progression, optimal therapy for inflammatory, degenerative diseases of the joints represents a major unmet medical need and a significant commercial opportunity,” added Samuel Broder, MD, Senior Vice President and Head of Intrexon’s Health Sector. “With Intrexon’s Better DNA® suite of proprietary technologies, our innovative engineered cell-based therapies may provide long-lasting effect while minimizing the repeated injections necessary with current treatments.”

Under the terms of the agreement, Intrexon will receive a technology access fee of $10 million in cash and reimbursement for all research and development costs. The agreement also provides for regulatory and commercial milestone payments to Intrexon for each collaboration product of up to $30 million and $22.5 million, respectively, as well as a low double-digit royalty based on the net sales from collaboration products.

Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs. Fibrocell’s most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast technology and is in a Phase II clinical trial for the treatment of chronic dysphonia resulting from vocal cord scarring. In collaboration with Intrexon Corporation, a leader in synthetic biology, Fibrocell is also developing gene therapies for skin and joint diseases using gene-modified autologous fibroblasts. Fibrocell is in preclinical development of FCX-007, its orphan gene-therapy product candidate, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is also in preclinical development of FCX-013, its gene-therapy product candidate, for the treatment of linear scleroderma. In addition, Fibrocell and Intrexon will be commencing preclinical development of a gene-therapy for the treatment of chronic inflammatory and degenerative diseases of the joint, including arthritis and related conditions. For more information, visit www.fibrocell.com.

Intrexon Corporation is Powering the Bioindustrial Revolution with Better DNA™ to create biologically based products that improve the quality of life and the health of the planet. The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com.