MONTREAL, May 23, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (TSX:TH) is pleased to announce that it has reached a pricing agreement with the AIDS Drug Assistance Program Crisis Task Force. The agreement opens access to Trogarzo™ (ibalizumab-uiyk) injection and EGRIFTA® (tesamorelin for injection) to low income, underinsured and uninsured Americans in all 50 states and the territories.
Trogarzo™ represents a critical new treatment advance as the first HIV therapy with a new mechanism of action approved in 10 years and proven efficacy in difficult-to-treat patients with multi-drug resistant HIV-1.
EGRIFTA® is a growth hormone-releasing factor analog and is the only FDA-approved treatment indicated for the reduction of excess abdominal fat in HIV infected patients with lipodystrophy.
“I am very proud of the agreement we concluded with ADAP. Both Trogarzo™ and EGRIFTA® are uniquely indicated to address important unmet medical needs of people living with HIV. We want to ensure that no one is left behind and ultimately having both products on ADAP’s formularies will go a long way towards this goal,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
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 the territories. Task Force membership is currently comprised of representatives from Arizona, California, Florida, Illinois, Massachusetts, New York, North Carolina, Tennessee, Texas, Virginia, and Washington state HIV/AIDS divisions.
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.
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 EGRIFTA® (tesamorelin for injection)
EGRIFTA® is currently approved in the United States, Canada and Mexico.
You should not take EGRIFTA® if you
- have or have ever had any problems with your pituitary gland.
- have cancer or are receiving treatment for cancer.
- are allergic to tesamorelin or any of the ingredients in EGRIFTA®.
- are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider.
- are less than 18 years of age.
The most common side effects of EGRIFTA® include: joint pain, pain in legs and arms, swelling in your legs, muscle pain, tingling, numbness and pricking, nausea, vomiting. Full prescribing information is available at www.egrifta.com.
About Theratechnologies
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing 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 statements that are considered forward-looking information (“FLI”) within the meaning of securities laws that are based on our management’s belief and assumptions and on information currently available to our management. The forward-looking statements contained in this press release include, but are not limited to, the availability of reimbursements of TrogarzoTM and EGRIFTA® by ADAP to patients. 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 availability of both TrogarzoTM and EGRIFTA®, no restrictions on the reimbursement of both of those drugs and eligibility of patients to seek reimbursement from ADAP. These risks and uncertainties include, but are not limited to, the risk that TrogarzoTM and EGRIFTA® are subject to recalls, termination of our agreement with ADAP and rejected demand for reimbursement of any of those drugs by ADAP. We refer potential investors to the “Risk Factors” section of our Annual Information Form (AIF) dated February 6, 2018 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com. 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.
Information:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800 ext. 236