MeiraGTx Announces its Wholly-Owned Gene Therapy Manufacturing Facility in Shannon, Ireland has Received Commercial MIA Authorization for QC Testing
19 Juillet 2023 - 2:30PM
MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated,
clinical stage gene therapy company, today announced that after a
successful inspection by the Irish Health Products Regulatory
Authority (HPRA), it has received a Commercial
Manufacturer’s/Importer’s Authorization (MIA) for its Quality
Control (QC) testing facility at its GMP manufacturing site in
Shannon, Ireland.
“Receiving our first commercial license for our state-of-the-art
manufacturing facility in Shannon so rapidly is another testament
to the quality of the MeiraGTx team and our industry leading
end-to-end capabilities,” said Alexandria Forbes, Ph.D., president
and chief executive officer of MeiraGTx. “This certification not
only enables us to accelerate the development and delivery of our
own pipeline of gene therapies for a range of serious conditions,
but it also provides potential for MeiraGTx to generate additional
revenue as the industry faces increasing delays and shortages of
licensed, reliable QC testing for advanced therapies globally.”
Unique in its scale and integrated capabilities and stretching
over 150,000 square feet, the GMP Shannon facility is Ireland’s
first commercial-scale gene therapy manufacturing site and contains
three facilities. The first facility was built to be a flexible and
scalable center for viral vector production for clinical and
commercial supply. The second facility was built to manufacture
plasmid DNA – the critical starting material for producing gene
therapy products. The third facility serves as a QC hub performing
advanced biochemical quality control testing for release and
stability testing for MeiraGTx and its partners' clinical and
commercial programs.
About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a
vertically integrated, clinical-stage gene therapy company with six
programs in clinical development and a broad pipeline of
preclinical and research programs. MeiraGTx has core capabilities
in viral vector design and optimization and in-house gene therapy
GMP manufacturing facilities in London, United Kingdom and Shannon,
Ireland, and a transformative gene regulation platform technology
that allows precise, dose responsive control of gene expression by
oral small molecules with dynamic range that can exceed 5000-fold.
Led by an experienced management team, MeiraGTx has taken a
portfolio approach by licensing, acquiring and developing
technologies that give depth across both product candidates and
indications. MeiraGTx’s initial focus is on three distinct areas of
unmet medical need: ocular diseases, including both inherited
retinal diseases as well as large degenerative ocular diseases,
neurodegenerative diseases and severe forms of xerostomia. Though
initially focusing on the eye, central nervous system and salivary
gland, MeiraGTx plans to expand its focus to develop additional
gene therapy treatments for patients suffering from a range of
serious diseases.
Forward Looking StatementThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including, without limitation, statements regarding our product
candidate development and anticipated milestones regarding our
pre-clinical and clinical data, reporting of such data and the
timing of results of data and regulatory matters, as well as
statements that include the words “expect,” “will,” “intend,”
“plan,” “believe,” “project,” “forecast,” “estimate,” “may,”
“could,” “should,” “would,” “continue,” “anticipate” and similar
statements of a future or forward-looking nature. These
forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements, including, but not limited to, our
incurrence of significant losses; any inability to achieve or
maintain profitability, raise additional capital, repay our debt
obligations, identify additional and develop existing product
candidates, successfully execute strategic priorities, bring
product candidates to market, expansion of our manufacturing
facilities and processes, successfully enroll patients in and
complete clinical trials, accurately predict growth assumptions,
recognize benefits of any orphan drug designations, retain key
personnel or attract qualified employees, or incur expected levels
of operating expenses; the impact of the COVID-19 pandemic on the
status, enrollment, timing and results of our clinical trials and
on our business, results of operations and financial condition;
failure of early data to predict eventual outcomes; failure to
obtain FDA or other regulatory approval for product candidates
within expected time frames or at all; the novel nature and impact
of negative public opinion of gene therapy; failure to comply with
ongoing regulatory obligations; contamination or shortage of raw
materials or other manufacturing issues; changes in healthcare
laws; risks associated with our international operations;
significant competition in the pharmaceutical and biotechnology
industries; dependence on third parties; risks related to
intellectual property; changes in tax policy or treatment; our
ability to utilize our loss and tax credit carryforwards;
litigation risks; and the other important factors discussed under
the caption “Risk Factors” in our most recent quarterly report on
Form 10-Q or annual report on Form 10-K or subsequent 8-K reports,
as filed with the Securities and Exchange Commission. These and
other important factors could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While we may elect to update such forward-looking
statements at some point in the future, unless required by law, we
disclaim any obligation to do so, even if subsequent events cause
our views to change. Thus, one should not assume that our silence
over time means that actual events are bearing out as expressed or
implied in such forward-looking statements. These forward-looking
statements should not be relied upon as representing our views as
of any date subsequent to the date of this press release.
Contacts
Investors:MeiraGTxInvestors@meiragtx.com
or
Media:Jason Braco, Ph.D.LifeSci
Communicationsjbraco@lifescicomms.com
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