MONTREAL, QUEBEC--(Marketwired - Apr 8, 2013) - Theratechnologies Inc. (Theratechnologies) (TH.TO) today announced the termination of its distribution and licensing agreement with Ferrer Internacional, S.A. (Ferrer) for the commercialization of tesamorelin in Europe, Russia, South Korea, Taiwan and certain Asian countries for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Ferrer was also responsible for regulatory activities for tesamorelin in these territories.
"We have been working diligently to forge the most appropriate path for tesamorelin in Europe following the withdrawal of the application last June. Our work in this regard continues and, at this juncture, Ferrer and Theratechnologies have mutually agreed to terminate their agreement," stated Luc Tanguay, President and Chief Executive Officer of Theratechnologies.
"We are currently working with key physicians, patient groups, regulatory consultants and certain regulators to assess a potential re-filing in Europe for tesamorelin in 2013," added Luc Tanguay, President and Chief Executive Officer of Theratechnologies.
As a result of the termination of this agreement, Theratechnologies, through its wholly-owned subsidiary, now holds 100% of the commercialization rights for tesamorelin in Europe, Russia, South Korea, Taiwan and certain Asian countries.
Currently, there are no approved treatments for lipodystrophy in HIV-infected patients available in Europe.
Theratechnologies (TH.TO) is a biopharmaceutical company that specializes in innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation. This forward-looking information includes, but is not limited to, information regarding the potential re-filing of a marketing authorization application for tesamorelin in Europe and the approval of tesamorelin in Europe for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Forward-looking information is based upon a number of assumptions and is 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, that we will re-file a marketing authorization in Europe or in certain European countries only, that regulatory agencies in Europe will approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, that our third-party supplier of tesamorelin will have the capacity to manufacture and deliver tesamorelin to meet market demand, that our third-party supplier of tesdamorelin will be approved to manufacture products for resale in Europe, that no conflict will occur with our commercial partners in other territories and that we will have our own sales force or an agreement with a third party to distribute ans sell tesamorelin in Europe, if approved. These risks and uncertainties include, but are not limited to, the risk that we do not re-file a marketing authorization application for tesamorelin in Europe or in certain European countries only, that European regulatory agencies do not approve tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, that our third-party supplier of tesamorelin is unable or is not qualified to manufacture products for resale in Europe, that tesamorelin is subject to a recall or market withdrawal, that conflicts occur with our commercial partners which will divert management's attention, that we have no sales force or are unable to enter into an agreement with a third party for the distribution and sale of tesamorelin in Europe upon terms commercially acceptable to us.
Theratechnologies refers potential investors to the "Risk Factors" section of its Annual Report on Form 20-F dated February 26, 2013. The Annual Report on Form 20-F is available at www.sedar.com and at www.sec.gov under Theratechnologies' public filings. 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 information reflects current expectations regarding future events and speaks only as of the date of this press release and represents Theratechnologies' expectations as of that date.
Theratechnologies undertakes 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 laws.