MONTREAL, CANADA--(Marketwired - Sept. 1, 2016) - Theratechnologies Inc. (TSX:TH) is pleased to announce that it has concluded agreements with Praxis Pharmaceutical, S.A. and its subsidiary PRX Pharma Produtos Farmacêuticos Unipessoal, LDA ("Praxis") for the distribution and commercialization of EGRIFTA® (tesamorelin for injection) for the treatment of HIV-associated lipodystrophy in Spain and Portugal.
Under the terms of this agreement, Praxis will be responsible to conduct all regulatory activities required to obtain marketing approval for EGRIFTA® in both Spain and Portugal once central European approval has been obtained. Until then, Praxis will distribute EGRIFTA® through Named Patient Sales Programs.
Theratechnologies will manufacture and supply EGRIFTA® to Praxis at a predetermined transfer price.
"This agreement allows us to have a presence in two additional European countries. Both Spain and Portugal represent interesting markets that were not covered under the deal we signed last year with AOP Pharma. As we expand the number of countries where EGRIFTA® is available, we also increase revenue potential," said Luc Tanguay, President and CEO, Theratechnologies Inc.
Praxis is a company that works in the Health Sciences, based in the Parque Tecnológico de Miñano, Álava, Spain, and which operates in Europe and Latin America. Praxis develops and manufactures products for third parties, and also markets pharmaceutical products aimed at the treatment of orphan and low-incidence indications.
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
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, statements regarding the distribution of EGRIFTA® through Named Patients Sales Programs, marketing approval of EGRIFTA® in Europe, Spain and Portugal, our capacity to ensure a reliable source of supply of EGRIFTA® and to increase our revenue.
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: Praxis will be successful in distributing EGRIFTA® through Named Patients Sales Programs, EGRIFTA® will receive central European approval, EGRIFTA® will receive approval in Spain and Portugal, no additional clinical studies will be required by the regulatory authorities in Europe, Spain and Portugal to obtain these regulatory approvals, EGRIFTA® will be accepted by healthcare professionals, patients and third-party payors in Spain and Portugal, the relationships with our third-party suppliers will be conflict-free and we will have a continuous supply of EGRIFTA®.
These risks and uncertainties include, but are not limited to, the risk that regulatory changes prevent Praxis from distributing EGRIFTA® through Named Patient Sales Programs, EGRIFTA® is not approved in Europe, EGRIFTA® is not approved in Spain and Portugal, market recall or market withdrawal of EGRIFTA® occurs in the countries where EGRIFTA® is commercialized, additional clinical data are required as a condition to approving EGRIFTA® and manufacturing issues prevent us from supplying EGRIFTA® to Praxis.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 24, 2016 available at www.sedar.com for additional risks regarding the Company and its operation. 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.