Theratechnologies Announces Launch of Trogarzo® in Germany
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.
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.
For media inquiries:Denis BoucherVice President, Communications
and Corporate Affairs514-336-7800
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
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