ROCKVILLE, Md., Jan. 8, 2024
/PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the
U.S. District Court for the District of Delaware granted Sarepta Therapeutics, Inc.
(Sarepta) summary judgment on invalidity in a patent infringement
suit arising from Sarepta's manufacture and use of cultured host
cell technology covered by a University of
Pennsylvania (Penn)
patent that Sarepta uses to make clinical and commercial
supplies of SRP-9001 (also known as ELEVIDYS in the U.S.), for
itself and Roche, for the treatment of Duchenne muscular dystrophy.
REGENXBIO intends to file an immediate appeal.
REGENXBIO exclusively licensed the patent, U.S. Patent
No. 10,526,617 ('617), from Penn, which
is a joint plaintiff in the lawsuit. The lawsuit was filed
September 30, 2020, and a trial
was scheduled for the end of January
2024. The ruling on this expired patent does not impact
REGENXBIO's current licenses or therapeutic pipeline.
"We are disappointed by the decision and believe the court got
it wrong. We will appeal," said Patrick J.
Christmas, J.D., Chief Legal Officer of REGENXBIO.
"REGENXBIO will continue to take appropriate steps to vigorously
defend our patent rights."
"The strong patent protections in the U.S. have enabled the
robust development of new medicines and spurred growth in the
biotechnology industry," said Kenneth T.
Mills, President and Chief Executive Officer of REGENXBIO.
"We are proud of the impact our NAV® Technology Platform
has had on the gene therapy field and the thousands of patients
that have been treated with AAV gene therapies built on our
patented technology. We are not attempting to halt development or
production of gene therapies; we are seeking fair and reasonable
compensation for deliberate infringement."
A separate patent infringement action on a different
Penn patent brought
by REGENXBIO and Penn against
Sarepta in June 2023 is also pending.
This second infringement action concerns Sarepta's commercial
launch of products covered by U.S. Patent No. 11,680,274
('274), which covers Sarepta's AAVrh74-based gene therapy vector
products, including ELEVIDYS, and that are partnered with Roche
outside the U.S. The term of the '274 patent extends
to October 2027 and damages are being sought to
compensate REGENXBIO and its licensor, Penn.
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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