Theratechnologies Inc.: Health Canada Decision Appealed
MONTREAL, CANADA -- (Marketwire) -- 03/25/13 -- Theratechnologies
Inc. (TSX:TH) today announced that it has filed with Health Canada a
request for reconsideration of its Notice of
Non-compliance-Withdrawal (NON/w) for its New Drug Submission (NDS)
for tesamorelin proposed for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy.
The request was filed within the prescribed 30-day appeal period.
The NDS for EGRIFTA(TM) was originally submitted to Health Canada in
June 2011. It was based on the results from two Phase 3 clinical
trials, which enrolled more than 800 patients, and follows a
marketing approval for EGRIFTA(TM) by the U.S. Food and Drug
Administration received in November 2010.
Currently, there are no approved treatments for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy
available in Canada.
Based on an agreement signed in February 2012, Actelion
Pharmaceuticals Canada is the commercialisation partner for
EGRIFTA(TM) in Canada.
Theratechnologies (TSX:TH) is a biopharmaceutical company that
specializes in innovative therapeutic peptide products, with an
emphasis on growth-hormone releasing factor peptides. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com, on SEDAR at www.sedar.com and on the
Securities and Exchange Commission's website at www.sec.gov.
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 in not limited to,
information on the approval of EGRIFTA(TM) in Canada.
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, the fact that Health Canada will issue a positive
decision on the request for reconsideration and that the NDS will be
subjected to a new review process. Risks and uncertainties include,
but are not limited to, that Health Canada may reject the request for
reconsideration and that, even if it issues a positive decision, the
NDS be denied after the review process.
We refer potential investors to the "Risks Factors" section of our
Annual Report on Form 20-F dated February 26, 2013 available at
www.sedar.com, www.sec.gov and www.theratech.com. 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 statements reflect current expectations
regarding future events and speak only as of the date of this press
release and represent our 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 laws.
NATIONAL Public Relations
Press spacebar to pause and continue. Press esc to stop.