Fibrocell and Intrexon Announce Collaboration to Address Chronic Inflammatory and Degenerative Diseases of the Joint
January 04 2016 - 8:00AM
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene
therapy company translating personalized biologics into medical
breakthroughs, and Intrexon Corporation (NYSE:XON), a leader in
synthetic biology, today 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,”
stated Samuel Broder, M.D., 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.
About Fibrocell 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
(NYSE:XON), 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.
About Intrexon
CorporationIntrexon Corporation (NYSE:XON) 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.
Fibrocell Trademarks Fibrocell™
and Fibrocell Science® are trademarks of Fibrocell Science, Inc.
and/or its affiliates. All other names may be trademarks of
their respective owners.
Intrexon TrademarksIntrexon,
Powering the Bioindustrial Revolution with Better DNA, and Better
DNA are trademarks of Intrexon and/or its affiliates. Other names
may be trademarks of their respective owners.
Fibrocell Forward-Looking
StatementsThis press release contains, and our officers
and representatives may from time to time make, statements that are
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995. All statements that are not historical facts are hereby
identified as forward-looking statements for this purpose and
include statements relating to: the potential for the collaboration
to yield products to address chronic inflammatory and degenerative
diseases of the joint; the potential advantages and commercial
potential of any products that may be developed pursuant to the
collaboration; and other statements regarding our future
operations, financial performance and financial position,
prospects, strategies and objectives and other future events.
Forward-looking statements are based upon
management’s current expectations, intentions and beliefs and are
subject to a number of risks, uncertainties, assumptions and other
factors that could cause actual results and events to differ
materially and adversely from those indicated herein including,
among others: risks inherent in drug discovery and
development; varying interpretation of market and preclinical data;
the risk that results seen in preclinical studies may not be
replicated in humans; our ability to maintain our collaborations
with Intrexon; and the risks, uncertainties and other factors
discussed under the caption “Item 1A. Risk Factors” in our most
recent Form 10-K and Form 10-Q filings, as well as discussions of
potential risks, uncertainties and other important factors in our
subsequent filings with the Securities and Exchange Commission. As
a result, you are cautioned not to place undue reliance on any
forward-looking statements. Additionally, the forward-looking
statements contained in this press release represent our views only
as of the date of this release. While we may update certain
forward-looking statements from time to time, we specifically
disclaim any obligation to do so, whether as a result of new
information, future developments or otherwise.
Intrexon Forward-Looking
StatementsSome of the statements made in this press
release are forward-looking statements. These forward-looking
statements are based upon our current expectations and projections
about future events and generally relate to our plans, objectives
and expectations for the development of our business.
Although management believes that the plans and objectives
reflected in or suggested by these forward-looking statements are
reasonable, all forward-looking statements involve risks and
uncertainties and actual future results may be materially different
from the plans, objectives and expectations expressed in this press
release.
Investor & Media Relations
Contact: Karen CaseyFibrocell Science, Inc.405 Eagleview
BoulevardExton, PA 19341+1 (484) 713-6133kcasey@fibrocell.com
Christopher Basta Intrexon Corporation Vice President, Investor
Relations +1 (561) 410-7052 investors@intrexon.com
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