MONTREAL, CANADA -- (Marketwire) -- 03/04/13 -- Theratechnologies Inc. (TSX: TH) announced that the Therapeutic Products Directorate of Health Canada has issued today a Notice of Non-compliance-Withdrawal (NON/w) for its New Drug Submission (NDS) for tesamorelin proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. After analysis of the NDS, Health Canada concluded that the risks of tesamorelin outweighed its benefits under the proposed conditions of use. A NON/w is appealable by filing a Request for Reconsideration. It can be submitted within 30 days of receiving a NON/w.
"As a Canadian company, this is particularly disappointing. The decision made by Health Canada puts Canadian patients at a disadvantage to U.S. patients where EGRIFTA was approved more than two years ago. We are now looking at our alternatives with our commercial partner, Actelion, which could include appealing the decision made by TPD. We will make our decision known within the next 30 days," stated Luc Tanguay, President and CEO of Theratechnologies.
The NDS 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 (TSX: TH) 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 regarding the alternatives available to the Company and the timing within which a decision will be made and announced.
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 economically viable alternatives will be available to us and that the analysis and review of these alternatives may be made within the 30-day period referred to in this press release. These risks and uncertainties include, but are not limited to, the risk that our clinical dossier does not provide us with any economically viable alternatives or that our decision is not made within the 30-day period referred to in this press release.
Theratechnologies refers potential investors to the "Risk Factors" section of its Annual Report on Form 20-F dated February 26, 2013. The Annual Report on Form 20-F 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 laws.
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