Theratechnologies Announces that Trogarzo(TM) (Ibalizumab-Uiyk) Injection is Now Available in the U.S.


MONTREAL, April 30, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX:TH) is pleased to announce that its novel antiretroviral TrogarzoTM is now commercially available in the United States. TrogarzoTM is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 failing their current antiretroviral regimen.

“Given the clinical significance of TrogarzoTM for patients with multidrug resistant HIV-1, our goal was to ensure that it would be available as quickly as possible. Patients that have already been prescribed TrogarzoTM may now be able to receive treatment,” said Luc Tanguay, President and CEO, Theratechnologies Inc.

“We are also quite pleased that some payers have already updated their reimbursement policy to include Trogarzo™. While it will take a few more months before access is optimized, the initial feedback from payers is definitely going in the right direction,” added Mr. Tanguay. 

Trogarzo™ was approved by the U.S. Food and Drug Administration on March 6, 2018.

About TrogarzoTM (ibalizumab-uiyk) injection

TROGARZO is a CD4-directed post-attachment HIV-1 inhibitor.

Trogarzo™, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

Important Safety Information

Before you receive Trogarzo™, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. It is not known if Trogarzo™ may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Trogarzo™ passes into breast milk. 

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements.

Trogarzo™ can cause serious side effects, including:

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine.

The most common side effects of Trogarzo™ include: diarrhea, dizziness, nausea and rash.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo™. For more information, ask your healthcare provider or pharmacist.

Full prescribing information available at www.trogarzo.com

About Theratechnologies

Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. 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 belief 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, commercial access to treatment using TrogarzoTM and timeline to optimization of reimbursement by payers.

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: TrogarzoTM will be accepted by the marketplace for the treatment of multidrug resistant HIV-1, no delay will occur in the distribution of TrogarzoTM and payers will accept to add TrogarzoTM as a drug covered by their plans.

These risks and uncertainties include, but are not limited to the discovery of untowards side effects resulting from the use of TrogarzoTM, market availability and market acceptance of TrogarzoTM in the treatment of multidrug resistant HIV-1 and declined reimbursements by some major payers.

We refer potential investors to the “Risk Factors” section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies and its business. 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.

Media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
Tel.: (514) 336-7800, ext. 236