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."
"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.
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
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.
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.
 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, 2020https://doi.org/10.1016/ S2666-5247(20)30006-9