Theratechnologies Submits Tesamorelin F8 Formulation sBLA for FDA Review
25 September 2023 - 1:00PM
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 Company has filed a supplemental Biologics
License Application (sBLA) for the F8 formulation of tesamorelin to
the U.S. Food and Drug Administration (FDA) for review. Tesamorelin
is the only medication approved in the U.S. for the reduction of
excess abdominal fat in adults with HIV who have lipodystrophy.
Pharmacokinetic studies have shown
bioequivalence of the F8 formulation to the original F1 formulation
of tesamorelin (previously sold under the trade name EGRIFTA®). The
F8 formulation is eight times more concentrated than EGRIFTA® and
two times more concentrated than the F4 formulation sold in the
U.S. under the trade name EGRIFTA SV®, enabling a smaller volume of
administration as well as a new product presentation in a
multiple-dose vial (MDV) that is reconstituted only once per week.
The new formulation is patent protected in the U.S. until 2033.
“In our interactions with HIV healthcare
providers, we have seen their growing concern with the clinical
challenges of excess abdominal fat, a condition that can cause a
myriad of negative health consequences for their patients,” said
Christian Marsolais, Ph.D., Senior Vice President and Chief Medical
Officer at Theratechnologies. “We developed the F8 formulation of
tesamorelin to better address this medical need, as we continue to
demonstrate our commitment to the HIV community and healthy aging
for people with HIV.”
In accordance with the FDA’s filing review
period, Theratechnologies expects to receive an acknowledgment
letter of the sBLA application within 30 days along with a
Prescription Drug User Fee Act (PDUFA) goal date. The proposed
proprietary name for the F8 formulation, EGRIFTA MDVTM, is already
under review by the FDA.
About EGRIFTA
SV® (tesamorelin for
injection)
EGRIFTA SV® is approved in the U.S. for the
reduction of excess abdominal fat in HIV-infected adult patients
with lipodystrophy*. EGRIFTA SV® is a growth hormone releasing
factor (GHRF) analog that acts on pituitary cells in the brain to
stimulate the production and release of endogenous growth
hormone.
* Limitations of Use:
- Long-term cardiovascular safety of
EGRIFTA SV® has not been established. Consider risk/benefit of
continuation of treatment in patients who have not had a reduction
in visceral adipose tissue.
- EGRIFTA SV® is not indicated for
weight loss management as it has a weight neutral effect.
- There are no data to support
improved compliance with anti-retroviral therapies in HIV-positive
patients taking EGRIFTA SV®.
Do not use EGRIFTA SV® if a patient:
- Has a pituitary gland tumor, has had pituitary gland surgery,
has other problems related to their pituitary gland, or has had
radiation treatment to their head or head trauma.
- Has active cancer.
- Is allergic to tesamorelin or any of the ingredients in EGRIFTA
SV®.
- Is pregnant or planning to become pregnant.
The most commonly reported adverse reactions of
EGRIFTA SV® include: hypersensitivity reactions, hyperglycemia,
injection site reactions, arthralgia, pain in extremity, myalgia
and peripheral edema.
Refer to www.egriftasv.com for the full
prescribing information, patient information and instructions for
use for further details about this product.
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 our management’s beliefs and
assumptions and on information currently available to our
management. 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
bioequivalence of the F8 formulation to the original F1
formulation, the approval of the F8 formulation by the FDA and its
proposed trade name, EGRIFTA MDVTM, and the timelines to receive
the acknowledgement letter from the FDA. 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 this information since
actual results may vary from the Forward-Looking Statements.
Certain assumptions made in preparing the Forward-Looking
Statements include that: the FDA will determine that the F8
formulation is bioequivalent to the original F1 formulation, the
FDA will approve the F8 formulation and its proposed trade name
EGRIFTA MDVTM and the timelines set forth in this press release are
accurate. Forward-Looking Statements are subject to a number of
risks and uncertainties, many of which are beyond
Theratechnologies’ 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, those related to or arising from:
a delay in the receipt of the acknowledgement letter from the FDA
and the PDUFA date, a rejection of the sBLA by the FDA because it
deems that the submission does not contain all of the prescribed
information, and the non-approval of the F8 formulation by the FDA
preventing its commercial launch in the United States. We refer
current and potential investors to the “Risk Factors” section of
our Annual Information Form dated February 27, 2023, available on
SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov as an exhibit
to our report on Form 40-F dated February 28, 2023, under
Theratechnologies’ public filings for additional risks involved in
our business. 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 our expectations as of
that date. We undertake 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:
Media inquiries:Julie SchneidermanSenior
Director, Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
Investor Inquiries:Philippe DubucSenior Vice
President and Chief Financial
Officerpdubuc@theratech.com438-315-6608
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