uniQure Expands Intellectual Property Portfolio with Newly Issued Patent Providing Broad Protection of Insect Cell-Based AAV ...
July 18 2017 - 7:00AM
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy and
AAV manufacturing, today announced that the United States Patent
and Trademark Office (USPTO) has granted a patent for a proprietary
invention by uniQure which broadly covers an important component of
insect cell-based AAV manufacturing technology. The USPTO issued
patent number US 9,708,627, a member of one of uniQure’s Hermens
patent families, with claims covering the expression of both Rep78
and Rep52 proteins from a Rep78 nucleic acid sequence in insect
cells.
The newly issued Hermens ‘627 patent significantly expands
uniQure’s leading intellectual property portfolio related to
large-scale, highly reproducible manufacturing of AAV in insect
cells. This patent, which broadens earlier claims granted in this
patent family, is based on years of research by uniQure scientists
focused on enhancing the genetic stability of the Rep78/52 encoding
sequences used to produce AAV vectors in insect cells. The
technology covered in the Hermens ‘627 patent family is currently
widely applied in insect cell-based AAV manufacturing.
“As an early pioneer of insect cell-based AAV manufacturing, we
have continued to innovate and protect all aspects of our
proprietary technology that are essential for the efficient and
large-scale production of AAV vectors for commercial use,” stated
Jonathan Garen, chief business officer for uniQure. “With the
issuance of this patent, we have significantly increased the value
of our patent portfolio and advanced our leadership in the
manufacturing of AAV-based gene therapies.”
uniQure’s intellectual property portfolio for its manufacturing
platform includes multiple fundamental molecular and
process-related patents and extensive know how covering essential
production, purification, and processing steps that are necessary
for the large-scale insect cell-based manufacturing and for
compliance with the regulatory authorities.
In aggregate, uniQure owns seven AAV manufacturing patent
families in which 130 patents have been granted worldwide, and 55
applications are pending, including in the U.S., Europe, Asia and
South America. A comprehensive summary of uniQure’s AAV
manufacturing technology is available on the Company’s website.
About Gene Therapy Manufacturing at
uniQureuniQure produces its AAV-based gene therapies in
its own facilities with its proprietary manufacturing process,
which uses insect cells and baculoviruses, a common family of
viruses found in invertebrates. The Company's manufacturing
capabilities enable it to be an attractive collaborator for
academic research institutions and biotechnology and pharmaceutical
companies seeking to advance their programs into larger, late-stage
clinical trials that require commercial-scale
manufacturing.
uniQure’s facility in Lexington, Massachusetts is one of the
largest, most versatile gene therapy manufacturing plants in the
world. uniQure invested more than $25 million in designing,
constructing and equipping the 55,000-square foot facility
with state-of-the-art laboratories and commercial-scale
production capabilities. The facility offers 500-liter
capacity with the ability to expand to up to 2,000 liters when
needed.
About uniQureuniQure is delivering on the
promise of gene therapy – single treatments with potentially
curative results. We are leveraging our modular and validated
technology platform to rapidly advance a pipeline of proprietary
and partnered gene therapies to treat patients with CNS,
liver/metabolic and cardiovascular diseases. www.uniQure.com
uniQure Forward-Looking StatementsThis press
release contains forward-looking statements. All statements other
than statements of historical fact are forward-looking statements,
which are often indicated by terms such as "anticipate," "believe,"
"could," "estimate," "expect," "goal," "intend," "look forward to",
"may," "plan," "potential," "predict," "project," "should," "will,"
"would" and similar expressions. Forward-looking statements are
based on management's beliefs and assumptions and on information
available to management only as of the date of this press release.
These forward-looking statements include, but are not limited to,
the development of our gene therapy product candidates, the success
of our collaborations and the risk of cessation, delay or lack of
success of any of our ongoing or planned clinical studies and/or
development of our product candidates. Our actual results could
differ materially from those anticipated in these forward-looking
statements for many reasons, including, without limitation, risks
associated with corporate reorganizations and strategic shifts,
collaboration arrangements, our and our collaborators’ clinical
development activities, regulatory oversight, product
commercialization and intellectual property claims, as well as the
risks, uncertainties and other factors described under the heading
"Risk Factors" in uniQure’s 2016 Annual Report on Form 10-K filed
on March 15, 2017. Given these risks, uncertainties and other
factors, you should not place undue reliance on these
forward-looking statements, and we assume no obligation to update
these forward-looking statements, even if new information becomes
available in the future.
uniQure Contacts:
FOR INVESTORS:
Maria E. Cantor
Direct: 339-970-7536
Mobile: 617-680-9452
m.cantor@uniQure.com
Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder@uniQure.com
FOR MEDIA:
Tom Malone
Direct: 339-970-7558
Mobile: 339-223-8541
t.malone@uniQure.com
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