Theratechnologies files New Drug Submission for EGRIFTAŽ
Montreal, Canada - June 20, 2011 - Theratechnologies Inc. (TSX: TH) (NASDAQ: THER)
today announced that it has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for
EGRIFTAŽ (tesamorelin for injection).
EGRIFTA ® is an analogue of the growth hormone-releasing factor (GRF) proposed for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. Currently, there are no approved treatments for lipodystrophy in HIV patients available
"Following the launch of EGRIFTA ® in the U.S., Theratechnologies continues to pursue additional regulatory filings in
major markets around the world. As a Canadian-based company, we are pleased to move forward with a regulatory filing in our home
country," stated Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "Theratechnologies'
filing with Health Canada is part of our commitment to maximize the commercial potential of EGRIFTA ® and to help address
currently unmet medical needs here in Canada," concluded Mr. Huss.
The NDS is based on the positive results from two Phase 3 clinical trials, which enrolled more than 800 patients, and follows
a marketing approval for EGRIFTA ® by the U.S. Food and Drug Administration received in November 2010.
On June 6, 2011, Theratechnologies announced that its partner, Ferrer Internacional S.A., filed a Marketing Authorization Application
(MAA) with the European Medicines Agency for tesamorelin. If approved, tesamorelin will receive marketing authorization for the 27
European Union member countries as well as in Iceland, Liechtenstein and Norway.
About EGRIFTA ®
EGRIFTA ® , a once-daily injection, is a novel, stabilized analogue of GRF. GRF is a hypothalamic peptide that acts on the pituitary
cells in the brain to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH). GH has been shown to play
an important role in regulating lipid metabolism and body composition (e.g., increasing muscle mass and reducing fat) 1 .
About HIV-Associated Lipodystrophy
Several factors, including a patient's antiretroviral drug regimen and the HIV virus itself, are thought to contribute to HIV-associated
lipodystrophy, which is characterized by body composition changes. The changes in body composition may include accumulation of excess
abdominal fat accumulation, which is known as abdominal lipohypertrophy.
Theratechnologies (TSX: TH) (NASDAQ: THER) is a specialty pharmaceutical company that discovers and develops innovative therapeutic
peptide products, with an emphasis on growth-hormone releasing factor peptides. Its first product, EGRIFTA ® (tesamorelin for
injection), was approved by the United States Food and Drug Administration in November 2010. To date, EGRIFTA ® is the only
approved therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA ® has not
been approved in Canada.
EGRIFTA ® is currently marketed in the United States by EMD Serono pursuant to a collaboration and licensing agreement executed
in October 2008. In addition, Theratechnologies has signed distribution and licensing agreements with a subsidiary of Sanofi granting
them the exclusive commercialization rights for EGRIFTA ® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in Latin America, Africa and the Middle East and with Ferrer Internacional S.A. granting them the exclusive
commercialization rights for EGRIFTA ® for the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Company's website
at http://www.theratech.com/ . Additional information, including the Annual
Information Form and the Annual Report, is also available on SEDAR at http://www.sedar.com/ and on
the Securities and Exchange Commission's website at http://www.sec.gov/ .
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable
securities legislation, which statements may contain such words as "may", "would", "could", "will", "intend", "plan",
"anticipate", "believe", "estimate", "expect" and similar expressions. This forward-looking information
includes, but is not limited to, information regarding the potential approval of EGRIFTA ® for the
treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy in Canada and in other jurisdictions.
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 Health Canada and
other regulatory agencies in other jurisdictions will approve EGRIFTA ® for the treatment of excess abdominal fat in
adult HIV-infected patients with lipodystrophy and that no additional clinical trials will be required by Health
Canada and other regulatory agencies in other jurisdictions in order to approve EGRIFTA ® . These risks and
uncertainties include, but are not limited to, the risk that Health Canada and other regulatory agencies in
other jurisdictions do not approve EGRIFTA ® for the treatment of excess abdominal fat in adult
HIV-infected patients with lipodystrophy or that Health Canada or other regulatory agencies in
other jurisdictions require additional clinical studies prior to make any decision regarding
the approval or non-approval of EGRIFTA ® .
Theratechnologies refers potential investors to the "Risks and Uncertainties" section of its Annual Information
Form (AIF) dated February 22, 2011. The AIF is available at http://www.sedar.com/ and
at http://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 law.
1 Grunfeld C et al. J Acquir Immune Defic Syndr; 45:286-297 (2007). Lo J et al. JAMA, 300: 509518 (2008).
"Reproduced with permission - Theratechnologies "