Theratechnologies inc.
TSX : TH
NASDAQ : THER

Theratechnologies inc.

June 16, 2011 09:30 ET

Theratechnologies Rings NASDAQ Opening Bell

MONTREAL, QUEBEC--(Marketwire - June 16, 2011) -

Editors Note: Photos for this release will be available on the Canadian Press picture wire via Marketwire.

Theratechnologies Inc. (Theratechnologies) (TSX:TH) (NASDAQ:THER) was invited this morning to ring The NASDAQ Stock Market Opening Bell in New York City, to mark its recent listing on the stock exchange.

Based in Montreal, Quebec, Theratechnologies is the developer of EGRIFTA®, the only FDA approved therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.

Already listed on the Toronto Stock Exchange, Theratechnologies is now also listed on the NASDAQ Global Market (NASDAQ) under the ticker symbol "THER".

In attendance for the ceremony today were Paul Pommier, Chairman of the Board, John-Michel T. Huss, President and Chief Executive Officer and Luc Tanguay, Senior Executive Vice-President and Chief Financial Officer.

"We are entering a truly exciting phase in the evolution of our company and we are proud of our association with NASDAQ. Theratechnologies is well positioned for future growth as we continue to maximize the commercial potential of our lead product, EGRIFTA® and pursue the development of novel GRF products," said John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies.

Theratechnologies has been a publicly traded company in Canada for over 15 years. Products developed by Theratechnologies target unmet medical needs in specialty markets and are based on the company's core expertise in the research and development of novel growth releasing factor (GRF) products and more generally, in the field of innovative peptide products.

Its flagship product, EGRIFTA® (tesamorelin for injection), was approved in November 2010 by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. In the United States, EGRIFTA® was launched in January 2011 and is being commercialized by EMD Serono. EGRIFTA® has been filed for approval in Europe where Theratechnologies has a commercial agreement with Ferrer. In Latin America, where Theratechnologies and a subsidiary of Sanofi entered into a commercial agreement, Sanofi is responsible for seeking regulatory approval of EGRIFTA® and, upon obtaining thereof, to commercialize the product. Sales in the United States continue to increase steadily and both reimbursement and sales are meeting the company's expectations. The company estimates that approximately 237,000 HIV-infected patients in the U.S. are affected by lipodystrophy.

A Clear Strategy

Theratechnologies' four-pronged strategy aimed at growing the company is outlined as follows:

  • Maximizing global commercial opportunities for EGRIFTA®;
  • Developing tesamorelin to treat muscle wasting in patients with COPD;
  • Solidifying Theratechnologies' position as a leader in the field of novel GRF products; and
  • Pursuing external growth opportunities.

These corporate priorities are backed by a sound financial strategy focused on maintaining a solid balance sheet and engaging in responsible cash management practices.

Progress on Several Fronts

Theratechnologies is developing a clinical program for tesamorelin for the treatment of muscle wasting associated with Chronic Obstructive Pulmonary Disease (COPD). The COPD clinical program is expected to begin in September 2011.

The company continues to actively pursue its R&D activities to discover and develop novel GRF products. It is in the process of synthesizing a second generation GRF analog that may have the potential for administration methods other than injection.

Theratechnologies common shares began trading on NASDAQ under the ticker symbol "THER" on Wednesday June 15, 2011. Theratechnologies has retained its primary listing on the Toronto Stock Exchange under the ticker symbol "TH".

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, which is known as abdominal lipohypertrophy.

About Theratechnologies

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.

Theratechnologies is also looking to develop tesamorelin for the treatment of
muscle wasting associated with Chronic Obstructive Pulmonary Disease (COPD). Tesamorelin has been shown to increase muscle mass, which makes it a potential treatment for muscle wasting. The COPD clinical program is expected to begin in September 2011.

Additional Information about Theratechnologies

Further information about Theratechnologies is available on the Company's website at www.theratech.com. Additional information, including the Annual Information form and the Annual report, is also available on SEDAR at www.sedar.com and the Securities and Exchange Commission's website at www.sec.gov.

Forward-Looking Information

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 growth of Theratechnologies, the timing of the beginning of the COPD clinical program, the increase in sales of EGRIFTA® in the United States and the development of tesamorelin for the treatment of muscle wasting in COPD.

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 regulatory agencies in countries outside of the United States will approve EGRIFTA®, that EGRIFTA® will continue to be accepted by the marketplace in the United States and, if and when approved outside of the United States, will be accepted by the marketplace in those territories, that the sale trend of EGRIFTA® in the United States will continue at the current rate, that all elements will be in place to begin the COPD clinical program in September 2011, and that the development of tesamorelin for the treatment of muscle wasting in COPD will be successful. These risks and uncertainties include, but are not limited to, the risk that EGRIFTA® is not approved by regulatory agencies outside of the United States, that, even if approved, EGRIFTA® is not accepted by the marketplace and the level of sales, if any, in those other terriotiries, is not as expected, that sales of EGRIFTA® in the United States lose momentum and reach a plateau or a negative trend, that the beginning of the COPD clinical program is delayed, and that the results of clinical studies using tesamorelin to treat muscle wasting in COPD are negative and lead to a delay or discontinuation of such studies.

Theratechnologies refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (the "AIF") dated February 22, 2011. The AIF 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 law.

1Grunfeld C et al. J Acquir Immune Defic Syndr; 45:286-297 (2007). Lo J et al. JAMA, 300: 509518 (2008).

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Contact Information

  • Roch Landriault
    NATIONAL Public Relations
    514 843-2345