Theratechnologies Inc.: FDA Approves Alternative Storage Conditions
MONTREAL, QUEBEC -- (Marketwire) -- 01/21/13 -- Theratechnologies
Inc. (TSX:TH) (NASDAQ:THER) announced today that the U.S. Food and
Drug Administration (FDA) has granted approval of a Supplemental New
Drug Application (sNDA), filed by its commercial partner, EMD Serono,
Inc., providing for the revision of the EGRIFTA(TM) (tesamorelin for
injection) prescribing information, to include storage conditions for
the 2 mg vial up to 12 weeks at or below 25 degrees C after
dispensing to the patient. Previously, EGRIFTA(TM) could only be
stored between 2 degrees C and 8 degrees C (36 degrees F and 46
degrees F) until the expiration date.
"Bringing incremental improvements to EGRIFTA(TM)'s presentation and
formulation continues to be a top priority for Theratechnologies.
Being able to store EGRIFTA(TM) at temperatures reaching 25 degrees C
provides storage flexibility for patients who don't always have
access to a refrigerator. Other potential improvements are part of
our product lifecycle management strategy aimed at improving the
product," stated Luc Tanguay, President and CEO of Theratechnologies.
In September 2012, EGRIFTA(TM) became available as a single-vial
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. 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 is not limited to,
information regarding the improvement of EGRIFTA(TM) through the
development of new presentations and/or new formulations.
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 we will have the resources, skills and
know-how to continue improving EGRIFTA(TM), that the approval of the
sNDA will have an effect on the acceptance of EGRIFTA(TM) in the
marketplace, that results from our development work on an improved
presentation and/or formulation of EGRIFTA(TM) will be positive and
allow the pursuit of such development work. These risks and
uncertainties include, but are not limited to, the risk that
unexpected events, or lack of resources, or loss of key personnel or
know-how, or negative scientific results delay or result in the
cancellation of our development work on an improved presentation
and/or formulation of EGRIFTA(TM) and the risk that the marketplace
does not recognize the approval of the sNDA as an improvement to
Theratechnologies refers potential investors to the "Risk Factors"
section of its Annual Information Form (AIF) dated February 27, 2012.
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.
NATIONAL Public Relations
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