-- Agreement provides Sarepta with committed capacity and
dedicated manufacturing slots for GMP-grade plasmid production for
its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy
program, as well as plasmid capacity for future gene therapy
programs --
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision
genetic medicine for rare diseases and Aldevron, the leading
producer of custom nucleic acids, proteins, and antibodies for the
biotechnology industry, announced today that they have entered into
a long-term strategic relationship for the supply of plasmid DNA to
fulfill Sarepta’s needs for its gene therapy clinical trials and
commercial supply. Under the terms of the agreement, Aldevron will
provide GMP-grade plasmid for Sarepta’s micro-dystrophin Duchenne
muscular dystrophy (DMD) gene therapy program and Limb-girdle
muscular dystrophy (LGMD) programs, as well as plasmid source
material for future gene therapy programs, such as
Charcot-Marie-Tooth, MPS IIIA, Pompe and other CNS diseases.
“One of our highest priorities is building a robust supply chain
and scalable manufacturing that can accelerate and ensure robust
patient access to our pipeline of promising gene therapies on an
accelerated timeline,” said Doug Ingram, Sarepta’s president and
chief executive officer. “Aldevron, one of the top plasmid DNA
manufacturers in the world, is an important partner in fulfilling
our strategic objectives. This agreement is anticipated to provide
sufficient plasmid supply to support our ambitious development and
commercial gene therapy objectives.”
“Our greatest satisfaction comes in helping
companies whose research is making an impact on the lives of
patients and we are proud to partner with Sarepta, a company
dedicated to extending and saving lives,” said Michael Chambers,
chief executive officer and co-founder of Aldevron. “Aldevron has
made significant investments in people, processes and facilities to
support the pre-clinical, clinical and commercial production of
new, genetically-based therapies that have significant potential in
transforming disease.”
Founded in 1998, Aldevron supplies plasmid DNA
and gene editing enzymes to biopharmaceutical researchers
developing advanced gene-based medicines. The company employs a
team of 270 across its three locations in Fargo, North Dakota,
Madison, Wisconsin, and Freiburg, Germany. Its 70,000 square foot
facility in Fargo is the largest plasmid DNA GMP manufacturing
facility in the world.
About Sarepta
TherapeuticsSarepta is at the forefront of precision
genetic medicine, having built an impressive and competitive
position in Duchenne muscular dystrophy (DMD) and more recently in
gene therapies for 5 Limb-girdle muscular dystrophy diseases
(LGMD), Charcot-Marie-Tooth (CMT), MPS IIIA, Pompe and other
CNS-related disorders, totaling over 20 therapies in various stages
of development. The Company’s programs and research focus span
several therapeutic modalities, including RNA, gene therapy and
gene editing. Sarepta is fueled by an audacious but important
mission: to profoundly improve and extend the lives of patients
with rare genetic-based diseases. For more information, please
visit www.sarepta.com.
About Aldevron
Founded in 1998, Aldevron supplies plasmid DNA and gene editing
enzymes to biopharmaceutical researchers developing advanced
gene-based medicines. Aldevron also provides recombinant biological
products for veterinary and agriculture applications. Aldevron
specializes in GMP manufacturing and is known for inventing the
GMP-SourceTM quality system. Company headquarters are in Fargo,
N.D., with additional facilities in Madison, WI., and Freiburg,
Germany. For more information, please visit www.aldevron.com.
Forward-Looking
StatementsThis press release contains
"forward-looking statements." Any statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include statements regarding the expected benefits and
opportunities of the agreement between Sarepta and Aldevron;
Sarepta’s strategic objective to build a robust supply chain and
scalable manufacturing that can accelerate and ensure robust
patient access to Sarepta’s pipeline of promising gene therapies on
an accelerated timeline; the anticipation that the agreement with
Aldevron will provide sufficient plasmid supply to support
Sarepta’s ambitious development and commercial gene therapy
objectives; Sarepta’s product candidates having significant
potential in transforming disease; and Sarepta’s mission to
profoundly improve and extend the lives of patients with rare
genetic-based diseases.
These forward-looking statements involve risks
and uncertainties, many of which are beyond Sarepta’s control.
Known risk factors include, among others: the expected benefits and
opportunities related to the agreement with Aldevron may not be
realized or may take longer to realize than expected; Sarepta’s
dependence on Aldevron to produce plasmid DNA to fulfill Sarepta’s
needs for its gene therapy clinical trials and commercial supply,
including any inability on Sarepta’s part to accurately anticipate
product demand and timely secure manufacturing capacity to meet
product demand, may impair the availability of products to
successfully support various programs, including research and
development and the potential commercialization of Sarepta’s gene
therapy product candidates; if Aldevron were to cease providing
quality manufacturing and related services to Sarepta, and Sarepta
is not able to engage appropriate replacements in a timely manner,
Sarepta’s ability to manufacture its gene therapy product
candidates in sufficient quality and quantity would adversely
affect Sarepta’s various product research, development and
commercialization efforts; if Aldevron fails to adhere to
applicable cGMP and other applicable government regulations, or
experiences manufacturing problems, Sarepta will suffer significant
consequences, which could significantly delay or negatively impact
the success of Sarepta’s development efforts for its product
candidates; Sarepta may not be able to successfully scale up
manufacturing of its product candidates in sufficient quality and
quantity or within sufficient timelines, or be able to secure
ownership of intellectual property rights developed in this
process, which could negatively impact the development of its
product candidates; Sarepta’s gene therapy programs may not result
in any viable treatments suitable for clinical research or
commercialization due to a variety of reasons, including the
results of future research may not be consistent with past positive
results or may fail to meet regulatory approval requirements for
the safety and efficacy of product candidates; and even if
Sarepta’s gene therapy programs result in new commercialized
products, Sarepta may not achieve any significant revenues from the
sale of such products; and those risks identified under the heading
“Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K
for the year ended December 31, 2017 and most recent Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) as well as other SEC filings made by the Company
which you are encouraged to review.
Any of the foregoing risks could materially and
adversely affect the Company’s business, results of operations and
the trading price of Sarepta’s common stock. For a detailed
description of risks and uncertainties Sarepta faces, you are
encouraged to review Sarepta's 2017 Annual Report on Form 10-K and
most recent Quarterly Report on Form 10-Q filed with the SEC as
well as other SEC filings made by Sarepta. We caution investors not
to place considerable reliance on the forward-looking statements
contained in this press release. Sarepta does not undertake any
obligation to publicly update its forward-looking statements based
on events or circumstances after the date hereof.
Internet Posting of
InformationWe routinely post information that may be
important to investors in the 'For Investors' section of our
website at www.sarepta.com. We encourage investors and potential
investors to consult our website regularly for important
information about us.
Source: Sarepta Therapeutics, Inc.
Media and Investors:Sarepta Therapeutics,
Inc.Ian Estepan, 617-274-4052 iestepan@sarepta.comorW2O GroupJerica
Pitts, 312-858-3469jpitts@w2ogroup.com
For AldevronCorporate Contact:Ellen Shafer, 701-219-0333
ellen.shafer@aldevron.com
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