First commercial launch in Europe
MONTREAL, Sept. 10, 2020 /PRNewswire/ -- Theratechnologies
Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a
biopharmaceutical company focused on the development and
commercialization of innovative therapies, is pleased to announce
that Trogarzo® will be commercially available in
Germany as of tomorrow through its
subsidiary, Theratechnologies Europe Limited.
Theratechnologies filed its health technology assessment for
Trogarzo® with the Gemeinsamer Bundesausschuss (GB-A),
the German health authority. Based on German regulations,
Trogarzo® can be commercialized while the file is being
reviewed by the GB-A.
"HIV treatments with new modes of action are essential to
achieve and maintain viral suppression in clinical practice. In
light of COVID-19, viral suppression is more important than ever.
As the first monoclonal antibody for the treatment of HIV,
Trogarzo® will play a key role for patients needing a
new option to construct a fully suppressive regimen," said Prof.
Dr. Jürgen Rockstroh Senior Consultant at Bonn´s University
Hospital and President of the European AIDS Clinical Society.
"The fight against HIV is not over. We need to continue to raise
awareness about prevention, diagnosis and virologic control if we
want to end the HIV epidemic. While a majority of people living
with HIV are doing well and live long and productive lives, many
are not as fortunate due to multidrug resistance and we must not
forget them. They too should be able to aspire to reach an
undetectable viral load. To that end, we are delighted to be able
to launch this product this month in Germany and look forward to its wider
commercial availability in Europe
over the coming months," said Conor
Walshe, General Manager, Theratechnologies Europe
Limited
A recent study published in The Lancet Microbe concluded that
"HIV-1 multidrug cross-resistance remains an important concern,
despite the extensive number of antiretroviral drugs currently
available. Highly treatment-experienced patients, especially those
who have been given suboptimal combination ART, can develop highly
complex resistance-associated mutation patterns, conferring
cross-resistance to all widely available ARTs."[1]
"We are pleased and proud to enter the European market at such a
crucial time in the fight against HIV. Trogarzo® can
become a cornerstone treatment for people living with
multidrug-resistant HIV in Europe," said Mr. Paul Lévesque, President and
Chief Executive Officer, Theratechnologies.
About Trogarzo®
Trogarzo® is the first long-acting antiretroviral for
the treatment of HIV. It is a CD4-directed post-attachment HIV-1
inhibitor.
In Europe, Trogarzo®
is indicated in combination with other antiretroviral(s), for the
treatment of adults infected with multidrug resistant HIV-1
infection for whom it is otherwise not possible to construct a
suppressive antiviral regimen.
The most common side effects with Trogarzo (which may affect up
to 1 in 10 patients) are rash, diarrhea, dizziness, headache,
nausea (feeling sick), vomiting and tiredness.
For more information please visit www.trogarzo.de
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 Information
This 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 effects of
Trogarzo® on decreasing a patient's viral load and the
commercialisation of Trogarzo® in Germany as of September
11, 2020.
Forward-looking statements are based upon a number of
assumptions and 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
assumptions include but are not limited to, the following:
Trogarzo® will be commercialised as of September 11, 2020, Trogarzo® will be
accepted by the marketplace as a safe and effective drug and will
receive a positive review by the GB-A and no untoward side effects
will derive from the long-term use of Trogarzo®.
The risks and uncertainties include, among others, the risk that
the commercialisation of Trogarzo® is delayed,
physicians do not prescribe Trogarzo® and
Trogarzo® receives a negative review from the GB-A.
We refer potential investors to the "Risk Factors" section of
our annual information form dated February
24, 2020 and to our Form 40-F dated February 25, 2020 filed on EDGAR for additional
risks regarding the conduct of our business and Theratechnologies.
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.
[1] Pan-resistant HIV-1 emergence in the era of integrase
strand-transfer inhibitors: a case report; Lancet Microbe 2020; 1:
e130–35; Published Online June 11,
2020 https://doi.org/10.1016/ S2666-5247(20)30006-9