EgriftaTreatment for Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy
Update: Egrifta (tesamorelin) Now FDA Approved - November 10, 2010
NDA Submitted for Tesamorelin
Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration
MONTREAL, QUEBEC--(Marketwire - June 1, 2009) - Theratechnologies (TSX:TH) today announced that it has filed a New Drug Application ("NDA") with the US Food and Drug Administration ("FDA") for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
"The filing of this NDA brings us ever closer to our main objective which is to bring tesamorelin, a molecule that was discovered and developed internally, to the market," stated Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "I would like to acknowledge the work and devotion of all of those involved over many years from the discovery, preclinical and clinical development of tesamorelin to the more recent, and very diligent, efforts of our regulatory group," Mr. Rosconi said. "Each and every one has contributed to today's achievement, which is something we all strive for, but few achieve, in the biotech industry," he added.
"We plan to work closely with the FDA in order to facilitate the completion of their review," stated Ms. Martine Ortega, Vice President, Compliance and Regulatory Affairs at Theratechnologies. "Treatment for excess abdominal fat in HIV patients with lipodystrophy represents an unmet medical need. If approved, tesamorelin could be the first product available to treat this condition," she noted.
About HIV-Associated Lipodystrophy
Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence.
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the growth hormone releasing factor.
In 2008, Theratechnologies completed its Phase 3 clinical program evaluating tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy. The Company has also entered into a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.
Theratechnologies' growth strategy is firmly focused on the development and exploitation of tesamorelin in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs.
This press release contains information or 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 approval by the FDA of tesamorelin as a therapeutic product, the beneficial nature of tesamorelin for patients, the commercialization of tesamorelin and its success for the treatment of HIV-associated lipodystrophy. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or variations of them denote forward-looking information.
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 the Company's control, which could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: the risk that the FDA does not accept the NDA filing and, even if accepted, does not approve tesamorelin for the treatment of excess abdominal fat in HIV patients with lipodystrophy, the risk that the results from the treatment with tesamorelin varies from one patient to another and the risk that the Company may not be able to commercialize its tesamorelin in other potential lipodystrophy markets.
The Company refers potential investors to the "Risk and Uncertainties" section of the Company's Annual Information Form (the "AIF") dated February 24, 2009. The AIF is available at http://www.sedar.com/ under the Company's 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 only as of the date of release of this press release and represents the Company's expectations as of that date. The Company does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.
For more information, please contact Theratechnologies Inc. Aline Vandermeer Coordinator, IR & Communications 514-336-7800, ext. 229 firstname.lastname@example.org
Posted: June 2009
- FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy - November 11, 2010
- Theratechnologies: Update on timeline for FDA Action Date - July 22, 2010
- Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin - June 7, 2010
- FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application - March 22, 2010
- Theratechnologies Announces a Tentative New Date for the FDA Advisory Committee Review of the tesamorelin New Drug Application - February 25, 2010
- Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee - November 5, 2009
- U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin - August 12, 2009