Skip to main content

Theratechnologies Announces Reimbursement Agreement in Italy for Trogarzo® for Eligible Patients With Multi-Drug Resistant HIV-1

MONTREAL, Oct. 26, 2021 (GLOBE NEWSWIRE) — Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that it has reached an agreement with the Italian Medicines Agency, AIFA, for the reimbursement of Trogarzo® for eligible people aged 18 and older living with multi-drug resistant (MDR) HIV-1.

“This agreement is an important milestone for Trogarzo® and for HIV-1 patients in Italy,” said Conor Walshe, General Manager, Europe. “Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo® for all patients in need.  We expect to launch Trogarzo® in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months.”

Trogarzo® was first approved by the U.S. Food and Drug Administration (FDA) in March 2018 and was the first long-acting agent approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their current antiretroviral regimen. Trogarzo® was approved by the European Medical Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen and is also commercially available in Germany. A number of patients are also being treated with Trogarzo® in other European countries through early access programs. Theratechnologies plans to launch Trogarzo® on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo® and is working to secure pricing and reimbursement.

About Trogarzo®1
Trogarzo® a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.

Trogarzo® blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. Trogarzo® is administered every 2 weeks via intravenous infusion.

The most frequently reported adverse reactions were rash (9.2%), diarrhea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).

For more information on Trogarzo®, please contact medinfo.eu@theratech.com.

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 commercialization of Trogarzo® in Italy and other European countries.

Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements. Certain assumptions made in preparing the Forward-Looking Statements include that: the current pandemic wil not adversely affect the launch of Trogarzo® in Italy and the commercial availability of this drug in other European countries, the timelines set forth in this press release will be met, and Trogarzo® will not be subject to any recall.

Forward-Looking Statements 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 Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the ongoing COVID-19 pandemic on (a) the Company’s sales efforts and sales initiatives, including the launch of Trogarzo® in Italy and the commercial availability of this drug in other European countries, (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; 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 for additional risks related to the Company. 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 investor and media inquiries:
Leah Gibson
Senior Director, Investor Relations
communications@theratech.com
617-356-1009

1 Trogarzo (ibalizumab) [SMPC] : Theratechnologies Europe Limited; 2021.

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.