Theratechnologies Provides Follow-Up Regulatory Update on Tesamorelin
October 10 2012 - 7:30AM
Marketwired
Theratechnologies Inc. (TSX:TH) (NASDAQ:THER) provided an update
today regarding the progress of marketing authorization application
activities for tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in Canada, Latin
America and Europe.
Canada
As previously announced, Theratechnologies and its commercial
partner in Canada, Actelion Pharmaceuticals Canada Inc., received a
notice of non-compliance from Health Canada in June 2012. The
notice contained follow-up questions regarding long-term safety,
the proposed patient population and indication.
Theratechnologies and Actelion responded to the additional
questions within the prescribed 90-day period. Health Canada has
confirmed that the screening of the New Drug Submission (NDS) is
complete and that the regulatory review is now under way. The
Company expects to receive Health Canada's final decision regarding
the NDS within the statutory period of 150 days as per Health
Canada's regulations.
Latin America
Brazil
Theratechnologies and its commercial partner in Latin America,
sanofi, have been able to address all technical deficiencies
identified by Brazil's National Health Surveillance Agency (ANVISA)
following an audit of its Montreal-based third-party manufacturing
site in June 2012.
Following reception of the audit report, the Company met with
the manufacturer and identified and developed appropriate
corrective measures. The corrective measures proposed by ANVISA
have been agreed to by the third-party manufacturer and are
currently being implemented. The document evidencing compliance
with the corrective measures will be sent to the Brazilian
regulatory authorities by sanofi in the coming weeks. The final
step in the manufacturing assessment will be a conformational audit
by ANVISA.
The evaluation of the Brazilian marketing application is a
separate process, which is being conducted in parallel with the
manufacturing assessment.
Venezuela
Theratechnologies was advised by sanofi that the filing in
Venezuela made in June 2012 was deemed incomplete for technical
reasons by local authorities. Theratechnologies will support sanofi
with corrective measures and we expect sanofi to resubmit the file
in due course. As a result, the review process will then begin
anew.
Europe
Following the withdrawal of the Marketing Authorization
Application (MAA) filed with the European Medicines Agency (EMA)
announced in June 2012, we continue to actively assess and evaluate
various options to resubmit an application in this territory. This
evaluation is ongoing and no firm timelines are available as of
this date. Any new submission will be covered by a 10-year
exclusivity period if and once approved.
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 timeline related to the
receipt of a decision by the Canadian regulatory authority on the
NDS, the capacity of the Company to resubmit a marketing
authorization application in Europe and the exclusivity period
granted under European laws.
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 have adequately answered all of the questions issued
by Health Canada, that no new question will be raised by Health
Canada, that Health Canada will not be delayed in making its
regulatory review of the NDS, that the Company's third party
manufacturer will be able to implement successfully the corrective
measures requested by ANVISA, that ANVISA will not raise additional
deficiencies during its conformational audit and that the Company
will be able to file in Europe and overcome the issues raised by
the EMA in its original filing. These risks and uncertainties
include, but are not limited to, the risk that the Canadian
regulatory authority is delayed in its review of the NDS, that the
Company's third-party manufacturer is unable to implement the
corrective measures and, if implemented, are not implemented to the
satisfaction of ANVISA, that additional deficiencies are raised by
ANVISA, that no commercially viable options exist to make a new
submission in Europe and that the laws granting exclusivity
protection upon approval of a new pharmaceutical product in Europe
are amended.
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: Roch Landriault NATIONAL Public Relations
514-843-2345
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