Theratechnologies Inc.: FDA Approves Alternative Storage Conditions for EGRIFTA(TM)
January 21 2013 - 5:53AM
Marketwired
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
presentation.
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. 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.
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 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 EGRIFTA(TM).
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.
Contacts: NATIONAL Public Relations Denis Boucher
514-843-2393
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