Mr. Philippe Dubuc reports

THERATECHNOLOGIES SUBMITS SBLA FOR TROGARZO(TM) INTRAMUSCULAR (IM) METHOD OF ADMINISTRATION TO FDA

Theratechnologies Inc. has filed a supplemental biologics licence application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review. In the U.S., Trogarzo, in combination with other anti-retrovirals (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.

The Trogarzo IM sBLA submission follows the recent FDA approval of the company's labelling prior approval supplement to include a 2,000-milligram intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics. The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo treatment regimen.

"The intramuscular method of administration, if approved for the maintenance dose, will give patients and their health care providers more options for Trogarzo treatment and without the need for regular IV placement," said Christian Marsolais, PhD, senior vice-president and chief medical officer at Theratechnologies. "Our vision through the introduction of IV push administration and, hopefully soon, IM administration, is that Trogarzo treatment will be a less invasive and more convenient proposition for heavily treatment-experienced adults with HIV, a population that has long had limited non-oral treatment options."

In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.

About Trogarzo

Trogarzo (ibalizumab-uiyk) is a long-acting, CD4-directed, postattachment HIV-1 inhibitor. In the United States, Trogarzo, in combination with other anti-retroviral(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 anti-retroviral regimen. Trogarzo is not approved in Canada.

Trogarzo is administered by intravenous (IV) infusion as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks after dilution in 250 millilitres of 0.9 per cent sodium chloride injection. The Trogarzo loading dose can also be administered as an undiluted IV push over 90 seconds, and the maintenance dose can be administered as an undiluted IV push over 30 seconds.

About Theratechnologies Inc.

Theratechnologies 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.

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