ROCKVILLE, Md., June 20,
2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX)
today announced that it has filed a second complaint for patent
infringement against Sarepta Therapeutics, Inc. (Sarepta) arising
from Sarepta's manufacture, use and imminent commercial launch of
SRP-9001 for the treatment of Duchenne muscular dystrophy.
The complaint asserted U.S. Patent No. 11,680,274, which covers
Sarepta's AAVrh74-based gene therapy vector products, including
SRP-9001. REGENXBIO exclusively licensed the newly issued patent
from the University of Pennsylvania
(Penn), which is a joint plaintiff in
the lawsuit. The term of the patent-in-suit extends to October 2027 and damages are being sought to
compensate REGENXBIO and its licensor, Penn, which originated the adeno-associated virus
(AAV) gene therapy technology.
"Through our clinical programs and the licensing to other
biopharmaceutical companies with disease-specific expertise,
thousands of patients have been treated with AAV gene therapies
built on REGENXBIO's NAV® Technology Platform," said
Kenneth T. Mills, President and
Chief Executive Officer of REGENXBIO. "We are proud of our
technology and its potential to enable life-changing medicines. Our
NAV Technology Platform is being applied over a broad range of
disease indications by our NAV Technology Licensees and
public-private partnerships such as the NIH/FDA Bespoke Gene
Therapy Consortium, all with a focus on ensuring patient
access."
"We believe that Sarepta unlawfully exploited groundbreaking
inventions and has continued to use them without a license," said
Patrick Christmas, Chief Legal
Officer of REGENXBIO. "We have taken the appropriate steps to
vigorously defend our intellectual property rights. We are not
attempting to halt production of gene therapies, we are seeking
compensation for the defendants' deliberate infringement."
The complaint was filed June 20,
2023 in the federal district court of Delaware, where a separate patent infringement
action previously brought by REGENXBIO and Penn against Sarepta is pending, arising from
Sarepta's manufacture and use of cultured host cell technology
covered by another Penn patent, U.S.
Patent No. 10,526,617, that Sarepta uses to make the SRP-9001
product. That lawsuit was brought September
30, 2020 and the trial is scheduled for January
2024.
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 and AAV9. REGENXBIO and
its third-party NAV Technology Platform Licensees are applying the
NAV Technology Platform in the development of a broad pipeline of
candidates, including late-stage and commercial programs, in
multiple therapeutic areas. REGENXBIO is committed to a "5x'25"
strategy to progress five AAV Therapeutics from our internal
pipeline and licensed programs into pivotal-stage or commercial
products by 2025.
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," "assume," "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, the impact of the
COVID-19 pandemic or similar public health crises on REGENXBIO's
business, 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, 2022, 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. Except as required by law,
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:
Dana
Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey, ICR Westwicke
339-970-2843
chris.brinzey@westwicke.com
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SOURCE REGENXBIO Inc.