Theratechnologies Provides Regulatory Update on Tesamorelin
Montreal, Canada - June 22, 2012 - Theratechnologies Inc. (TSX: TH) (NASDAQ: THER)
announced today important regulatory updates regarding the European Union,
Canada and Brazil.
European Union
Theratechnologies has been informed by Ferrer Internacional S.A. (Ferrer), its
commercial partner responsible for all regulatory filings in Europe, that it is withdrawing
the Marketing Authorization Application (MAA) filed with the European Medicines
Agency (EMA) for tesamorelin for the treatment of excess abdominal fat in HIVinfected
patients with lipodystrophy.
Ferrer's decision to withdraw the MAA follows an oral explanation with the EMA's
Committee for Medicinal Products for Human Use (CHMP). As higher IGF-1 (Insulinlike
growth factor 1) levels were identified as a potential safety concern for long-term
use of tesamorelin, the CHMP indicated that the lack of data on cardiovascular risk
markers did not allow the committee to conclude on a positive benefit/risk balance.
As a result of the withdrawal of the MAA in the European Union, Theratechnologies is
revising its guidance and no longer expects to be EBITDA positive in 2013. Further
guidance will not be provided at this time.
Canada
Theratechnologies also announced that it has received a notice of non-compliance
(NON) from the Therapeutic Products Directorate of Health Canada regarding the New
Drug Submission (NDS) for tesamorelin for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy. The NON contains questions regarding the
long-term safety of tesamorelin, the appropriate patient population and the proposed
indication.
The Company and its commercial partner in this territory, Actelion Pharmaceuticals
Canada Inc., have 90 days to answer the questions. The Company now expects to
receive Health Canada's final decision regarding the NDS during the first half of 2013.
Brazil
Theratechnologies has been informed by Sanofi, its commercial partner responsible
for all regulatory affairs in Latin America, that Brazil's National Health Surveillance
Agency (ANVISA) has audited and identified technical deficiencies with the Montrealbased
third-party manufacturing site for tesamorelin. The manufacturer has indicated
that it is in a position to implement ANVISA's recommendations with regards to these
deficiencies. However, this development may delay Brazil's regulatory decision.
The Company is currently assessing the impact of these recent developments on its
strategic objectives.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Company's website
at http://www.theratech.com/ . Additional information, including the Annual
Information Form and the Annual Report, is also available on SEDAR at http://www.sedar.com/ and on
the Securities and Exchange Commission's website at http://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 timeline related to
the receipt of a decision by the Brazilian and Canadian regulatory authorities on the
application filed in each of those countries for tesamorelin for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy.
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 the Company will be able to answer in a satisfactory manner
all of the questions raised by the Canadian regulatory authority, that no additional
questions will be asked following the answers to the questions contained in the NON,
that the Company's third party manufacturer will be able to implement successfully the
recommendations made by ANVISA, that ANVISA will not raise additional deficiencies
and that ANVISA will review the implementation of the recommendations and provide
feedback thereon in a timely manner. These risks and uncertainties include, but are
not limited to, the risk that the Company is unable to provide satisfactory answers to
the questions contained in the NON related to the safety and efficacy of tesamorelin,
that additional questions are raised further to the answers provided, that the Canadian
regulatory authority is delayed in its review of the answers to be provided, that the
Company's third-party manufacturer is unable to implement the recommendations and,
if implemented, are not implemented to the satisfaction of ANVISA, that additional
deficiencies are raised or that ANVISA is delayed in its review of the implemented
recommendations.
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 http://www.sedar.com/ and
at http://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.
Contact:
Serge Vallières
NATIONAL Public Relations
Phone: 514-843-2310
"Reproduced with permission - Theratechnologies "
Theratechnologies
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