Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH)
(NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, is
pleased to announce that a study evaluating an intravenous (IV)
push form of administration of Trogarzo® for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection achieved consistent
and statistically significant results demonstrating that there was
no difference in pharmacokinetics (PK) between IV Push and IV
Infusion. Based on these results, a supplemental Biologics License
Application (sBLA) is expected to be filed with the U.S. Food and
Drug Administration (FDA) in the fourth quarter of 2021.
The TMB-302 study was
conducted by the Company’s partner, TaiMed Biologics (TaiMed), to
evaluate the safety and comparability of the current Trogarzo® IV
Infusion mode of administration with a more convenient IV Push form
of administration that can be infused within 30 seconds without
dilution compared to the 15-minute infusion time of the original IV
Infusion.
“These results confirm
that the IV Push method of administration of Trogarzo® is an
effective alternative to the current IV Infusion administration,”
said Paul Levesque, President and Chief Executive Officer of
Theratechnologies. “This more convenient IV Push mode of
administration also offers patients a rapid infusion time and
requires only two quick infusions per month. We are confident that
this faster infusion may further increase patient compliance,
allowing patients to benefit from long-acting protection against
HIV-1 when Trogarzo® is administered with other
antiretrovirals.”
The primary endpoint
measuring a 90% confidence interval of the ratio of IV Push to IV
Infusion was within the target value. The proportion of subjects
with mean trough serum drug concentration equal or exceeding the
target concentration was also the same for both forms of
administration. Additionally, there were no serious adverse events
observed and drug-related adverse events were considered mild to
moderate.
Secondary endpoints
were also achieved confirming no difference in HIV-1 viral load due
to the change from IV Infusion to IV Push. Additionally, there were
no anti-Trogarzo® antibodies or immunogenicity concerns of
Trogarzo® detected.
Theratechnologies and
TaiMed are currently evaluating an intramuscular (IM) method of
administration for Trogarzo® as part of the TMB-302 study with
patient screening planned for the fourth quarter of
2021. The study will be conducted and funded by
Theratechnologies with support from TaiMed.
Under the terms of the
agreement with TaiMed, Theratechnologies is entitled to
commercialize the new IV Push and IM methods of administration of
Trogarzo® if, and when, approved.
About
Trogarzo®Trogarzo® is a CD4-directed
post-attachment HIV-1 inhibitor. Trogarzo® is approved for
commercialization in the United States and in the European Union.
In the United States, Trogarzo®, in combination with other
antiretroviral(s), is indicated for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in heavily
treatment-experienced adults with multidrug resistant HIV-1
infection failing their current antiretroviral regimen.
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.sedar.com and on
EDGAR at www.sec.gov
Forward-Looking InformationThis press release
contains forward-looking statements and forward-looking
information, or, collectively, 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",
“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 filing of an sBLA with the FDA and the timing of such
filing, the convenience of the IV Push method of administration,
the increase in patient compliance and seeking approval of the IV
Push mode of administration, the development of the IM method of
administration for Trogarzo® and the timelines to initiate
same.
Although the forward-looking information
contained in this press release is 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 information. Certain assumptions made in preparing
the forward-looking statements include that: the current COVID-19
pandemic will have limited adverse effect on the Company’s
operations; sales of Trogarzo® in the United States and Europe will
increase over time; the IV Push method of administration will be
approved by the FDA and, if approved, will be accepted by the
marketplace; the long-term use of Trogarzo® will not change its
safety profile; no recall or market withdrawal of Trogarzo® will
occur; no laws, regulation, order, decree or judgment will be
passed or issued by a governmental body negatively affecting the
marketing, promotion or sale of Trogarzo® in countries where such
products are commercialized; continuous supply of Trogarzo® will be
available; the timelines set forth in this press release will be
met; the Company’s relations with third-party suppliers of its
products will be conflict-free and such third-party suppliers will
have the capacity to manufacture and supply the Company’s products
to meet market demand on a timely basis; and the Company’s business
plan will not be substantially modified.
Forward-looking information assumptions 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 information. These risks and uncertainties
include, but are not limited to, those related to or arising from:
the adverse impact of the COVID-19 pandemic on (a) the Company’s
sales efforts and sales initiatives, (b) the capacity of the
Company’s suppliers to meet their obligations vis-à-vis the
Company, (c) the Company’s research and development activities, (d)
the health of the Company’s employees and its capacity to rely on
its resources, as well as (e) global trade; the non-approval by the
FDA of the IV Push method of administration; delays in filing the
sBLA seeking approval of the IV Push method of administration and
delays in initiating the development of the IM method of
administration for Trogarzo® as part of the TMB-302 study; the
Company’s ability and capacity to grow the sales of Trogarzo®
successfully in the United States and in Europe; the Company’s
capacity to meet supply and demand for its products; the market
acceptance of the IV Push method of administration of Trogarzo®, if
and when approved, in the United States; the Company’s expectations
regarding its financial performance, including revenues, expenses,
gross margins, profitability, liquidity, capital expenditures and
income taxes; and the Company’s estimates regarding its capital
requirements.
We refer current and
potential investors to the “Risk Factors” section of our Annual
Information Form dated February 24, 2021 available on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our
report on Form 40-F dated February 25, 2021 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 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.
For media and investor inquiries:Leah
GibsonSenior Director, Investor
Relationscommunications@theratech.com617-356-1009
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