Theratechnologies Announces Resumed Production of EGRIFTA SV®
December 03 2024 - 4:30PM
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced that the production of EGRIFTA SV® has resumed following
a voluntary shutdown of the Company’s contract manufacturer’s
facility to address observations from an inspection by the US Food
and Drug Administration (FDA).
One newly manufactured batch of EGRIFTA
SV® has completed standard quality control and will be
available for release to the market upon approval from the FDA of a
Prior Approval Supplement, which the Company is expected to file
around mid-December 2024. The manufacturing of two additional
batches of EGRIFTA SV® is currently underway. The Company
implemented measures to carefully manage existing inventory levels
of EGRIFTA SV® to meet patient demand until mid-January
2025.
Theratechnologies continues to collaborate
closely with the relevant divisions of the FDA and other key
stakeholders to avoid a shortage at the patient level in 2025.
The Company will update the market on any
further material developments.
EGRIFTA SV® is distributed in the United States
only.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies addressing unmet medical
needs. Further information about Theratechnologies is available on
the Company's website at www.theratech.com, on SEDAR+
at www.sedarplus.ca and on EDGAR at www.sec.gov.
Follow Theratechnologies
on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking statements and
forward-looking information (collectively, the “Forward-Looking
Statements”) within the meaning of applicable securities laws, that
are based on management’s beliefs and assumptions and on
information currently available to it. You can identify
forward-looking statements by terms such as “may”, “will”,
“should”, “could”, “promising”, “would”, “outlook”, “believe”,
“plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the
negatives of these terms, or variations of them.
The Forward-Looking Statements contained in this
press release include, but are not limited to, statements regarding
the release of the newly manufactured batch of EGRIFTA SV®, the
time period related to the filing of the PAS and the availability
of EGRIFTA SV® to patients.
Although the Forward-Looking Statements
contained in this press release are based upon what the Company
believes are reasonable assumptions in light of the information
currently available, investors are cautioned against placing undue
reliance on these statements since actual results may vary from the
Forward-Looking Statements contained in this press release. Certain
assumptions made in preparing the Forward-Looking Statements
include that: (i) the Company will receive all of the relevant
information from its third party manufacturer to file a PAS within
the timelines set forth herein; (ii) the FDA will review and
approve the PAS before mid-January 2025; (iii) the two additional
batches of EGRIFTA SV® will be within specifications when
manufacturing is completed; and (iv) current market demand for
EGRIFTA SV® will remain unaffected despite the risk of drug
shortage.
Forward-Looking Statements assumptions are
subject to a number of risks and uncertainties, many of which are
beyond the Company’s control, that could cause actual results to
differ materially from those that are disclosed in or implied by
such Forward-Looking Statements. These risks and uncertainties
include, but are not limited to: (i) drug shortage of EGRIFTA SV®
due to various factors, including delays in filing the PAS,
rejection of the PAS for failure to meet regulatory requirements,
the issuance of comments by the FDA on the PAS impacting its review
timelines; and (ii) a decrease in demand for EGRIFTA SV® due to the
risk of shortage.
The Company refers current and potential
investors to the “Risk Factors” section of the Company’s annual
information form filed under Form 20-F dated February 21, 2024,
available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov
under Theratechnologies’ public filings. The reader is cautioned to
consider these and other risks and uncertainties carefully and not
to put undue reliance on forward-looking statements.
Forward-Looking Statements reflect current expectations regarding
future events and speak only as of the date of this press release
and represent the Company’s expectations as of that date.
The Company undertakes no obligation to update
or revise the information contained in this press release, whether
as a result of new information, future events or circumstances or
otherwise, except as may be required by applicable law.
Contacts:
Investor inquiries:Philippe Dubuc Senior Vice President and
Chief Financial Officerpdubuc@theratech.com438-315-6608
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
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