Exhibit 99.1
News Release
Theratechnologies files New Drug Submission for EGRIFTA®
with Health Canada
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 EGRIFTA® (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 in Canada.
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 patients 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 Inc.
2310 Alfred-Nobel Blvd., Montréal, Québec, Canada H4S 2B4
Phone: 514 336-7800 Fax: 514 336-7242 www.theratech.com
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.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Companys 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 on the Securities
and Exchange Commissions 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 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
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.
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Grunfeld C et al. J Acquir Immune Defic Syndr; 45:286-297 (2007). Lo J et al. JAMA,
300: 509518 (2008). |
Contact:
Roch Landriault
NATIONAL Public Relations
Phone: 514-843-2345