ROCKVILLE, Md., May 15, 2019 /PRNewswire/ -- REGENXBIO Inc.
(Nasdaq: RGNX), a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy based on its proprietary NAV® Technology
Platform, today announced its plan to construct a current good
manufacturing practice (cGMP) production facility, to be located in
Rockville, Maryland. The new cGMP
production facility will be integrated into REGENXBIO's previously
announced new 132,000 square foot headquarters, for which
construction is currently underway, and will allow for production
of NAV Technology-based vectors at scales up to 2,000 liters using
REGENXBIO's platform suspension cell culture process. The
facility will be designed to meet global regulatory requirements
and is expected to be operational in 2021. The cGMP production
facility will complement the company's current external
manufacturing capabilities, enabling a reliable supply of NAV
vectors from both internal and external sources. The construction
of the facility is not expected to have any effect on REGENXBIO's
previously issued financial guidance relating to its cash, cash
equivalents and marketable securities as of December 31, 2019.
"REGENXBIO's own cGMP production facility is designed to enable
us to reach manufacturing scales suitable for future commercial
production," said Curran Simpson,
Senior Vice President of Product Development and Chief Technology
Officer at REGENXBIO. "The creation of this additional
manufacturing capacity using our platform suspension cell culture
process will allow us to more efficiently advance our development
programs from research stage to the clinic and ultimately to
patients, while ensuring manufacturing capacity availability. We
expect our manufacturing network to be capable of supporting our
internal programs through clinical development and potential
commercialization."
"The manufacturing facility design will enable concurrent
production of multiple gene-therapy vectors, and the facility will
be co-located with our process development and analytical
teams. This integrated approach will allow for more efficient
development, manufacture and release of vectors for new
indications," said Kenneth T. Mills,
President and Chief Executive Officer of REGENXBIO. "The new
facility will also provide us with scheduling flexibility, allowing
for reduced product development timelines at sufficient capacity to
meet clinical and projected commercial requirements."
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. REGENXBIO's NAV Technology Platform, a proprietary
adeno-associated virus (AAV) gene delivery platform, consists of
exclusive rights to more than 100 novel AAV vectors, including
AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV
Technology Platform Licensees are applying the NAV Technology
Platform in the development of a broad pipeline of candidates in
multiple therapeutic areas.
Forward-Looking Statements
This press release includes "forward-looking statements," within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements express a belief, expectation or
intention and are generally accompanied by words that convey
projected future events or outcomes such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "design," "intend,"
"expect," "could," "plan," "potential," "predict," "seek,"
"should," "would" or by variations of such words or by similar
expressions. The forward-looking statements include statements
relating to, among other things, REGENXBIO's future operations and
clinical trials. REGENXBIO has based these forward-looking
statements on its current expectations and assumptions and analyses
made by REGENXBIO in light of its experience and its perception of
historical trends, current conditions and expected future
developments, as well as other factors REGENXBIO believes are
appropriate under the circumstances. However, whether actual
results and developments will conform with REGENXBIO's expectations
and predictions is subject to a number of risks and uncertainties,
including the timing of enrollment, commencement and completion and
the success of clinical trials conducted by REGENXBIO, its
licensees and its partners, the timing of commencement and
completion and the success of preclinical studies conducted by
REGENXBIO and its development partners, the timely development and
launch of new products, the ability to obtain and maintain
regulatory approval of product candidates, the ability to obtain
and maintain intellectual property protection for product
candidates and technology, trends and challenges in the business
and markets in which REGENXBIO operates, the size and growth of
potential markets for product candidates and the ability to serve
those markets, the rate and degree of acceptance of product
candidates, and other factors, many of which are beyond the control
of REGENXBIO. Refer to 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, 2018 and
comparable "risk factors" sections of REGENXBIO's Quarterly Reports
on Form 10-Q and other filings, which have been filed with the U.S.
Securities and Exchange Commission (SEC) and are available on the
SEC's website at www.sec.gov. All of the forward-looking statements
made in this press release are expressly qualified by the
cautionary statements contained or referred to herein. The actual
results or developments anticipated may not be realized or, even if
substantially realized, they may not have the expected consequences
to or effects on REGENXBIO or its businesses or operations. Such
statements are not guarantees of future performance and actual
results or developments may differ materially from those projected
in the forward-looking statements. Readers are cautioned not to
rely too heavily on the forward-looking statements contained in
this press release. These forward-looking statements speak only as
of the date of this press release. REGENXBIO does not undertake any
obligation, and specifically declines any obligation, to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contacts:
Investors:
Heather Savelle, 212-600-1902
heather@argotpartners.com
Media:
David Rosen, 212-600-1902
david.rosen@argotpartners.com
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SOURCE REGENXBIO Inc.