European Commission Approves Trogarzo®
September 26 2019 - 2:13PM
European Commission Approves Trogarzo®
Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to
announce that Trogarzo® (ibalizumab) was approved today by the
European Commission.
“The approval of Trogarzo® by the European
Commission represents a historical milestone for Theratechnologies
as it becomes our first product ever approved in that territory. We
have been getting ready for this moment and we will initiate our
launch plan to introduce Trogarzo® sequentially on a
country-by-country basis as we obtain public reimbursement.
Already, we are recording sales in Europe through early access
programs, which shows that there is already a high level of
interest for our unique HIV treatment,” said Luc Tanguay, President
and CEO, Theratechnologies Inc.
“Europe is the second largest pharmaceutical
market in the world and the approval of Trogarzo® represents a
tremendous opportunity for Theratechnologies. I am also very proud
to know that patients in Europe can now look forward to having
access to an innovative, safe and effective treatment to help them
get to undetectable levels of HIV,” added Luc Tanguay.
About Trogarzo® (Europe)
Trogarzo® is a CD4-directed post-attachment
HIV-1 inhibitor. Trogarzo®, in combination with other
antiretroviral(s), is indicated 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.
Before you receive Trogarzo®, ask your doctor
for advice if you are pregnant or plan to become pregnant as it is
not known if Trogarzo® may harm your unborn baby. Women who are
HIV-positive must not breast feed because HIV infection can be
passed on to the baby in breast milk. It is not known if Trogarzo®
passes into breast milk.
Talk to your doctor or nurse straight away if
you get any of the following serious side effects:
- Signs of a new infection, changes in your immune system, can
happen when you start using HIV medicines. Your immune system might
get stronger and begin to fight infections that have been hidden in
your body for a long time (this is called ‘immune reconstitution
inflammatory syndrome’). Look out for new signs of infection after
receiving Trogarzo®; these can be different from person to person
depending on the type of infection that was hidden and might
include fever, headache, difficulty breathing, stomach ache,
coughing and swollen glands (lumps and bumps on your body, neck,
armpit or groin).
- Allergic reaction (hypersensivity).
The most frequently reported adverse reactions
of Trogarzo® include: rash, diarrhea, dizziness, headache, nausea,
fatigue and vomiting. These are not all the possible side effects
of Trogarzo®.
About Theratechnologies
Theratechnologies (TSX: TH) is a
commercial-stage biopharmaceutical company addressing unmet medical
needs by bringing to market specialized therapies for people with
orphan medical conditions, including those living with HIV. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com and on SEDAR at
www.sedar.com.
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 launch of
Trogarzo® on a country-by-country basis, the obtaining of
reimbursement for Trogarzo®, the level of interest for Trogarzo®
and the safety and efficacy of Trogarzo®.
Forward-looking statements are based upon a
number of assumptions and include, but are not limited to, the
following: when launched, Trogarzo® will be accepted by the
European market place, Trogarzo® will be reimbursed in each
European country, the efficacy and safety of Trogarzo® will be
similar to those observed during the clinical trials and no
undesired side effects will be discovered over the long-term use of
Trogarzo® and Trogarzo® will not be subject to any product recall.
Forward-looking statements are subject to a
variety of risks and uncertainties, many of which are beyond our
control that could cause our actual results to differ materially
from those that are disclosed in or implied by the forward-looking
statements contained in this press release. These risks and
uncertainties include, among others, the risk that Trogarzo® is not
reimbursed by some or all of the European countries, that Trogarzo®
is not launched in certain European countries, that undesired side
effects are discovered over the long-term use of Trogarzo®, that
the safety and efficacy profile of Trogarzo® varies from patients
to patients, and that the European countries do not accept
Trogarzo® has a treatment to get to undetectable levels of HIV
resulting in low sales.
We refer potential investors to the "Risk
Factors" section of our annual information form dated February 20,
2019 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
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