MONTREAL, QUEBEC--(Marketwired - Jul 8, 2013) - Theratechnologies Inc. (TH.TO) today announced that it has received confirmation from Health Canada that it will be meeting with a scientific advisory committee on August 23, 2013 as part of the request for reconsideration process of the notice of non-compliance/withdrawal (NON/w) issued by Health Canada in March 2013.
Pursuant to the rules governing the request for reconsideration, representatives from Theratechnologies and Health Canada will be asked to present their respective arguments to the committee. The hearing is not open to the public.
Once the meeting is completed, members of the scientific advisory committee will have seven days to submit their report to the regulatory project manager who will have twenty-one days to review it and send it with his comments to the Director General. The Director General will then have five days to issue its decision.
If the decision is positive, the review of EGRIFTA™ will resume at the same stage as it was before the issuance of the NON/w.
Further information on the request for reconsideration process can be found on Health Canada's website at www.hc-sc.gc.ca.
The New Drug Submission for EGRIFTA™ 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™ 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.
Theratechnologies (TH.TO) 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 SEC'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 on the timelines of the process regarding the request for reconsideration filed with Health Canada and the effect of a positive outcome resulting from a decision of the Director General following the hearing held in the context of the request for reconsideration.
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 not be delayed in meeting its timelines, the report issued by the scientific advisory committee will be favorable to the Company and the revision of such report by the regulatory project manager and the Director General will be positive as well. Risks and uncertainties include, but are not limited to, that Health Canada may be delayed in meeting the timelines described in this press release, the report issued by the scientific advisory committee is not favorable to the Company or that revisions to this report result in a negative review of EGRIFTA™ or that the outcome of the review of the file after a positive recommendation from the Director General is negative.
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.