MONTREAL, Sept. 19, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (TSX: TH) is pleased to announce that an agreement has been reached with the AIDS Drug Assistance Program Crisis Task Force for EGRIFTA SVTM (tesamorelin for injection), which will commercially launch in the United States very shortly. The agreement will help to facilitate access to low income, underinsured and uninsured Americans living with HIV in all 50 states and territories of the United States.
EGRIFTA SVTM is a growth hormone-releasing factor. On November 5, 2018, the FDA approved EGRIFTA SVTM for the reduction of excess abdominal fat in HIV infected patients with lipodystrophy.
Trogarzo® agreement renewed
Further to reaching an agreement for EGRIFTA SVTM, Theratechnologies and the task force also agreed to renew the contract for Trogarzo® until December 31, 2021.
Trogarzo® was approved by the FDA on March 6, 2018. It represents a critical treatment advance for people living with persistent HIV. It is the first HIV therapy with a new mechanism of action approved in 10 years.
“Theratechnologies remains strongly committed to be a partner and part of the solution in helping people living with HIV and contributing to ending the HIV epidemic in the United States,” declared Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
“A strong partnership with pharmaceutical manufacturers is key to ensuing that critical medications are available to people living with HIV at the best possible price to AIDS Drug Assistance Programs. We want to thank Theratechnologies for entering into good-faith negotiations with the Task Force and for the company’s commitment to mutually beneficial agreements that will potentially benefit ADAP clients,” said Mr. Tim Horn, Director, Medication Access and Pricing, NASTAD.
Formed in 2002, the Task Force negotiates reduced drug prices for all ADAPs. ADAPs provide HIV treatments to low-income, uninsured, and underinsured individuals living with HIV/AIDS in all 50 states and territories of the United States. Task Force membership is currently comprised of representatives from Arizona, California, Florida, Illinois, Massachusetts, New York, North Carolina, Texas, Virginia, and Washington state HIV/AIDS divisions.
About EGRIFTA SVTM (tesamorelin for injection)
EGRIFTA SVTM is currently approved in the United States only.
Do not use EGRIFTA SVTM if a patient:
• Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head.
• Has active cancer.
• Is allergic to tesamorelin or any of the ingredients in EGRIFTA SVTM.
• Is pregnant or planning to become pregnant.
The most common side effects of EGRIFTA SVTM include: injection site reactions, arthralgia, pain in extremity, myalgia and edema peripheral.
About TROGARZO® (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.
Before you receive Trogarzo®, tell your healthcare provider if you are pregnant or plan to become pregnant as it is not known if Trogarzo® may harm your unborn baby or if you are breastfeeding or plan to breastfeed as 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.
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. 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 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 EGRIFTA SVTM and the access to EGRIFTA SVTM to low income, underinsured and uninsured Americans living with HIV in the United States.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: EGRIFTA SVTM and TROGARZO® will be accessible to a wide range of HIV-patients in the United States as a result of the agreement entered into with ADAP, the efficacy and safety of EGRIFTA SVTM and TROGARZO® will not change over the course of their use, none of those drugs will be subject to recalls and patients’ response to a treatment with those drugs will be positive.
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 undesired side effects develop for any of those drugs, that products recall occur, that patients respond negatively to a treatment with any of those drugs, that U.S. HIV-patients do not have rapid access to any of those drugs and that our agreement with ADAP is not renewed in the long term.
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.
Media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
Tel.: (514) 336-7800, ext. 236