MONTREAL, CANADA–(Marketwired – Aug. 31, 2015) – Theratechnologies Inc. (TSX:TH) is pleased to announce that it has concluded an agreement with BL&H Co., LTD (BL&H) for the distribution and commercialization of EGRIFTA™ (tesamorelin for injection) for the treatment of HIV-associated lipodystrophy in South Korea.
Under the terms of this agreement, BL&H will be responsible to conduct all regulatory activities required to obtain marketing approval for EGRIFTA™ in South Korea. Until then, BL&H intends to distribute EGRIFTA™ in the territory through Named Patient Sales Programs.
Theratechnologies will manufacture and supply EGRIFTA™ to BL&H at a predetermined transfer price. The agreement has a 10-year term.
“We are thrilled of our association with BL&H which has a fast growing portfolio of specialty products in South Korea. This agreement gives us a great opportunity to enter a new market over a short time frame. One objective of our 2015 business plan is finding partners to distribute EGRIFTA™ in additional territories. Today’s announcement brings us closer to achieving this goal and it represents another significant step towards bringing shareholder value through the realization of the full commercial potential of EGRIFTA™,” said Luc Tanguay, President and CEO, Theratechnologies Inc.
BL&H is a privately-owned company based in Seoul, South Korea. It is a leading distributor of pharmaceuticals and hospital-based products and services in South Korea.
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and an improved quality of life. 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 South Korea and our capacity to ensure a reliable source of supply of EGRIFTA™.
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: BL&H will be successful in distributing EGRIFTA™ through Named Patients Sales Programs, EGRIFTA™ will receive regulatory approval in South Korea, no additional clinical studies will be required by the regulatory authorities in South Korea to obtain these regulatory approvals, EGRIFTA™ will be accepted by healthcare professionals, patients and third-party payors in South Korea, 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 BL&H from distributing EGRIFTA™ through Named Patient Sales Programs, EGRIFTA™ is not approved in South Korea, 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 BL&H.
We refer potential investors to the “Risk Factors” section of our Annual Information Form dated February 25, 2015 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.