Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene
therapy company developing life-changing treatments for severe
diseases of the central nervous system (CNS), and REGENXBIO Inc.
(Nasdaq:RGNX), a leading biotechnology company focused on the
development, commercialization and licensing of recombinant
adeno-associated virus (AAV) gene therapy based on its proprietary
NAV® Technology Platform (NAV), today announced that Voyager has
exercised commercial options for the use of REGENXBIO’s NAV vectors
for the development and commercialization of gene therapies for
specific neurological diseases.
Upon exercise of the options, REGENXBIO has
granted Voyager a non-exclusive worldwide commercial license, with
rights to sublicense, to three specific NAV vector sequences
covered by REGENXBIO’s NAV Technology Platform, each for the
treatment of a specific neurological disease. In return for
these rights, REGENXBIO will receive undisclosed upfront payments,
ongoing fees, milestone payments and royalties on net sales of
products incorporating the licensed intellectual property.
“Today’s announcement aligns with our stated
goal of advancing our multiple preclinical programs during this
year and into 2017 towards selection of lead clinical candidates,”
said Steven Paul, M.D., President and Chief Executive Officer of
Voyager Therapeutics. “Exercising the commercial options with
REGENXBIO represents an important step for our preclinical pipeline
programs, and we are excited with the progress of our continued
collaboration with REGENXBIO.”
“These option exercises serve as further
validation of our proprietary NAV Technology Platform, the breadth
of our intellectual property portfolio, and the unique properties
of NAV vectors for targeting the central nervous system and a
number of other organ systems,” said Kenneth T. Mills, President
and Chief Executive Officer of REGENXBIO. “As a leader in
next-generation AAV gene therapy, REGENXBIO is pleased to continue
our collaboration with Voyager and its pursuit of developing and
delivering life-changing treatments for severe diseases of the
CNS.”
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene
therapy company developing life-changing treatments for severe
diseases of the CNS. Voyager is committed to advancing the
field of AAV (adeno-associated virus) gene therapy through
innovation and investment in vector engineering and optimization,
manufacturing and dosing and delivery techniques. The
Company’s pipeline is focused on severe CNS diseases in need of
effective new therapies, including advanced Parkinson’s disease, a
monogenic form of ALS, Friedreich’s ataxia, Huntington’s disease,
frontotemporal dementia, Alzheimer’s disease and severe, chronic
pain. Voyager has broad strategic collaborations with Sanofi
Genzyme, the specialty care global business unit of Sanofi, and the
University of Massachusetts Medical School. Founded by
scientific and clinical leaders in the fields of AAV gene therapy,
expressed RNA interference and neuroscience, Voyager Therapeutics
is headquartered in Cambridge, Massachusetts. For more
information, please visit www.voyagertherapeutics.com. Follow
Voyager on LinkedIn.
About REGENXBIO
REGENXBIO is a leading biotechnology company
focused on the development, commercialization and licensing of
recombinant adeno-associated virus (AAV) gene therapy. REGENXBIO’s
NAV® Technology Platform, a proprietary AAV gene delivery platform,
consists of exclusive rights to more than 100 novel AAV vectors,
including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO’s mission is to
transform the lives of patients suffering from severe diseases with
significant unmet medical need by developing and commercializing in
vivo gene therapy products based on REGENXBIO’s NAV Technology
Platform. REGENXBIO seeks to accomplish this mission through a
combination of internal development efforts and third-party NAV
Technology Platform licensees. As of September 30, 2016,
REGENXBIO’s NAV Technology Platform was being applied in the
development of 29 product candidates for a variety of diseases,
including five internally developed candidates and 24 partnered
candidates developed by REGENXBIO’s licensees.
Voyager Forward-Looking
Statements
This press release contains forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995 and other federal
securities law. The use of words such as “may,” “might,” “will,”
“should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,”
“project,” “intend,” “future,” “potential,” or “continue,” and
other similar expressions are intended to identify forward-looking
statements. For example, all statements Voyager makes
regarding the initiation, timing, progress, enrollment and
reporting of top-line and other results of its preclinical programs
and clinical trials and its research and development programs, its
ability to advance its AAV-based gene therapies into, and
successfully complete, clinical trials, its ability to continue to
develop its product engine, its ability to add new programs to its
pipeline, its expected cash, cash equivalents and marketable
securities at the end of a fiscal year and anticipation for how
long expected cash, cash equivalents and marketable securities will
last, and the timing or likelihood of its regulatory filings and
approvals, are forward looking. All forward-looking
statements are based on estimates and assumptions by Voyager’s
management that, although Voyager believes to be reasonable, are
inherently uncertain. All forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those that Voyager expected. These
statements are also subject to a number of material risks and
uncertainties that are described in Voyager’s most recent Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission, as updated by its future filings with the Securities
and Exchange Commission. Any forward-looking statement speaks
only as of the date on which it was made. Voyager undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law.
REGENXBIO Forward-Looking
Statements
This press release contains “forward-looking
statements,” within the meaning of the Private Securities
Litigation Reform Act of 1995, regarding, among other things,
REGENXBIO’s NAV Technology Platform, REGENXBIO’s collaborations
with its NAV Technology Licensees and the research, development and
regulatory plans of REGENXBIO’s NAV Technology Licensees. Such
forward-looking statements are based on current expectations and
involve inherent risks and uncertainties, including factors that
could cause actual results to differ materially from those
projected by such forward-looking statements. All of REGENXBIO’s
development timelines could be subject to adjustment depending on
recruitment rate, regulatory agency review and other factors that
could delay the initiation and completion of clinical trials.
Meaningful factors which could cause actual results to differ
include, but are not limited to, the timing of enrollment,
commencement and completion of REGENXBIO’s clinical trials; the
timing and success of preclinical studies and clinical trials
conducted by REGENXBIO, its development partners and its NAV
Technology Licensees; the ability to obtain and maintain regulatory
approval to conduct clinical trials and to commercialize
REGENXBIO’s product candidates, and the labeling for any approved
products; the scope, progress, expansion, and costs of developing
and commercializing REGENXBIO’s product candidates; REGENXBIO’s
ability to obtain and maintain intellectual property protection for
REGENXBIO’s product candidates and technology; trends and
challenges in REGENXBIO’s business and the markets in which
REGENXBIO operates; REGENXBIO’s ability to attract or retain key
personnel; the size and growth of the potential markets for
REGENXBIO’s product candidates and the ability to serve those
markets; the rate and degree of market acceptance of any of
REGENXBIO’s product candidates; REGENXBIO’s ability to establish
and maintain development partnerships, including those with NAV
Technology Licensees; REGENXBIO’s expenses and revenue, the
sufficiency of REGENXBIO’s cash resources and needs for additional
financing, regulatory developments in the United States and foreign
countries, as well as other factors discussed in the “Risk Factors”
and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” sections of REGENXBIO’s Annual Report on
Form 10-K for the year ended December 31, 2015 and Quarterly Report
on Form 10-Q for the quarter ended September 30, 2016, which are
available on the SEC’s website at www.sec.gov. In addition to the
risks described above and in REGENXBIO’s filings with the SEC,
other unknown or unpredictable factors also could affect
REGENXBIO’s results. There can be no assurance that the actual
results or developments anticipated by REGENXBIO will be realized
or, even if substantially realized, that they will have the
expected consequences to, or effects on, REGENXBIO. Therefore, no
assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this
press release are expressly qualified by the cautionary statements
contained or referred to herein. REGENXBIO cautions investors not
to rely too heavily on the forward-looking statements REGENXBIO
makes or that are made on its behalf. These forward-looking
statements speak only as of the date of this press release (unless
another date is indicated). REGENXBIO undertakes no obligation, and
specifically declines any obligation, to publicly update or revise
any such forward-looking statements, whether as a result of new
information, future events or otherwise.
Voyager Investor Relations Contact:
Matt Osborne
Head of Investor Relations & Corporate Communications
857-259-5353
mosborne@vygr.com
Voyager Media Contact:
Katie Engleman
Pure Communications, Inc.
910-509-3977
Katie@purecommunicationsinc.com
REGENXBIO Investors Contact:
Heather Savelle, 646-395-3734
heather@argotpartners.com
REGENXBIO Media Contact:
Laura Bagby, 312-448-8098
lbagby@6degreespr.com
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