http://www.theratech.com () —
Theratechnologies (TSX: TH) announced today that a distribution and
licensing agreement was signed with sanofi-aventis ("Sanofi"), for the
commercialization rights to EGRIFTA (tesamorelin for injection) in
Latin America, Africa and the Middle East for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy.
Terms of the Agreement
Under the terms of the Agreement, Theratechnologies will be
responsible to supply EGRIFTA to Sanofi. Sanofi will buy EGRIFTA
from Theratechnologies at an undisclosed selling price.
Theratechnologies has kept all future development rights to EGRIFTA
and will be responsible for conducting research and development for
any additional programs. Sanofi will be responsible to conduct all
regulatory activities in the aforementioned territories in connection
with EGRIFTA for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy, including seeking the
approval of EGRIFTA in the different countries. Theratechnologies
granted Sanofi an option to commercialize EGRIFTA in the
aforementioned countries for other uses.
"Having worked in the sanofi-aventis group for the last 11 years, I am
confident that this collaboration will be a strong and fruitful one
for both of us. Building long-lasting mutually beneficial
relationships will be a key to success for Theratechnologies. This is
another critical step towards bringing value to our shareholders and
further demonstrates our ability to execute our business plan,"
commented Mr. John-Michel T. Huss, President and CEO of
Theratechnologies. "Sanofi's strong foothold and knowledge in these
countries are invaluable assets to lead the submission process to the
various regulatory agencies. Moreover, Sanofi's extensive
commercialization experience, which I know of first-hand, will be an
important aspect of providing market access to EGRIFTA as rapidly as
possible," concluded Mr. Huss.
"The structure of this agreement clearly emphasizes that we believe
strongly in the potential of EGRIFTA in these territories," noted Mr.
Luc Tanguay, Senior Executive Vice President and CFO of
Theratechnologies. "This transaction is structured for
Theratechnologies to receive a fair percentage of the selling price
which will have a direct effect on our recurring revenues, and on the
bottom-line, as we do not need to directly increase our expenses in
order to achieve these revenues," concluded Mr. Tanguay.
Conference Call and Webcast
The Company will hold a conference call and webcast today at 8:30 a.m.
to discuss this strategic agreement. To participate, please dial:
1-416-981-9000 or 1-800-785-6380 (toll free). Please dial-in five
minutes prior to the teleconference in order to ensure your
participation. The webcast will be available on the Company's website
at http://www.theratech.com (http://www.theratech.com) and at
http://www.gowebcasting.com/2144.
A replay of the conference call will be available from 10:30 a.m.
today, December 6, 2010, until December 20, 2010, at 11:59 p.m. at the
following number: 1-416-626-4100, pass code 21495399‥ or
1-800-558-5253, pass code 21495399‥. The webcast will be posted for 15
days at the link indicated above.
About EGRIFTA
EGRIFTA(tesamorelin for injection) is a synthetic analogue of the
human growth hormone releasing factor ("GRF") shown to reduce visceral
fat in HIV-infected patients with excess abdominal fat associated with
lipodystrophy. GRF is a hypothalamic peptide that acts on the
pituitary cells in the brain to stimulate the synthesis and release of
endogenous growth hormone. EGRIFTA is approved for sale in the United
States only.
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 excess abdominal fat
accumulation, which is known as abdominal lipohypertrophy.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company
that discovers and develops innovative therapeutic products, with an
emphasis on peptides. The Company targets unmet medical needs in
specialty markets where it can retain all or part of the commercial
rights to its products. Its most advanced product, tesamorelin, an
analogue of the human growth hormone releasing factor, was recently
approved by the U.S. Food and Drug Administration as the first and
only treatment for excess abdominal fat in HIV-infected patients with
lipodystrophy. Tesamorelin is being exclusively commercialized in the
U.S. by EMD Serono under the brand name EGRIFTA.
For more information, please visit www.theratech.com
(http://www.theratech.com)
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
For more information on Sanofi-aventis, visit
http://www.sanofi-aventis.com (http://www.sanofi-aventis.com)
Forward-Looking Information
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 growth of
Theratechnologies.
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 that could cause actual results to differ
materially from those that are disclosed in or implied by such
forward-looking information. The assumptions made include, among
others, that regulatory agencies in countries outside of the United
States will also approve EGRIFTA, and that Sanofi will be successful
in commercializing EGRIFTA in the territories outlined in this press
release. 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, or the risk that the commercialization
efforts for EGRIFTA do not result in the expected growth of the
Company.
The Company refers potential investors to the "Risks and
Uncertainties" section of its Annual Information Form (the "AIF")
dated February 23, 2010. The AIF is available at www.sedar.com
(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 and speaks only as of the date of this press release and
represents the Company's expectations as of that date.