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), and Voyager
Therapeutics, Inc. (Nasdaq:VYGR), a clinical-stage gene therapy
company developing life-changing treatments for severe diseases of
the central nervous system (CNS), 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.
“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.”
“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.”
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.
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.
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 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 CONTACT:
Investors
Heather Savelle, 646-395-3734
heather@argotpartners.com
Media
Laura Bagby, 312-448-8098
lbagby@6degreespr.com
VOYAGER CONTACT:
Investor Relations:
Matt Osborne
Head of Investor Relations & Corporate Communications
857-259-5353
mosborne@vygr.com
Voyager Media:
Katie Engleman
Pure Communications, Inc.
910-509-3977
Katie@purecommunicationsinc.com
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