Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration
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MONTREAL, QUEBEC, Jun 01 (MARKET WIRE) --
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.
About Theratechnologies
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.
Forward-Looking Information
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.
Contacts:
Theratechnologies Inc.
Aline Vandermeer
Coordinator, IR & Communications
514-336-7800, ext. 229
avandermeer@theratech.com
Copyright 2009, Market Wire, All rights reserved.
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