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Theratechnologies Provides Regulatory Update on Tesamorelin
 
 
  Press Release: Theratechnologies inc. - Fri, Jun 22, 2012

MONTREAL, QUEBEC--(Marketwire -06/22/12)- Theratechnologies Inc. 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 HIV-infected 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 (Insulin-like 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 Montreal-based 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.

Contact:

Serge Vallieres
NATIONAL Public Relations
Phone: 514-843-2310

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New Phase II, NIH-sponsored Study Demonstrates Metabolic Effects of Tesamorelin in Obese Subjects With Reduced Growth Hormone Secretion

Study results presented at 94th Annual Meeting of the Endocrine Society, Houston, Texas, Tuesday, June 26, 2012


MONTREAL, CANADA--(Marketwire - June 27, 2012) - Theratechnologies Inc. (TSX:TH)(NASDAQ:THER) is pleased to announce that results of a study entitled Metabolic Effects of a Growth Hormone-Releasing Factor in Obese Subjects with Reduced Growth Hormone Secretion were presented yesterday at ENDO 2012. The study was conducted at the Harvard Clinical Translational Science Centre at the Massachusetts General Hospital by Dr. Steven K. Grinspoon and was sponsored with grants from the U.S. National Institutes of Health (NIH).

The placebo-controlled study demonstrated that, among obese subjects with relative reductions in growth hormone (GH), tesamorelin selectively reduces visceral adipose tissue (VAT) in the abdominal area, without significant effects on subcutaneous adipose tissue (SAT). Tesamorelin was also shown to improve triglycerides, C-reactive protein and carotid intima medial thickness (cIMT), without aggravating glucose. These data suggest a functional consequence of reduced GH secretion in obesity and demonstrate an improved cardiovascular disease (CVD) risk profile resulting from tesamorelin. In addition, this study suggests, more broadly, that strategies to selectively reduce VAT and spare SAT may improve CVD risk in obesity. The results occurred in the context of a dosing algorithm designed to keep insulin-like growth factor-1 (IGF-1) within the normal physiological range. Tesamorelin is not approved for the treatment of obese patients with reduced growth hormone secretion. The complete abstract is available at http://theratech.us4.list-manage.com/track/click?u=e9f8f369e487080c8661a3551&id=a3053b4987&e=2e354fd993.

"It has long been demonstrated that obesity is associated with relative reductions in GH secretion. Results from this study show that increasing GH levels with tesamorelin can have positive impacts on abdominal fat in this patient population. Moreover, data from this model suggest that selectively reducing VAT without affecting SAT improves known cardiovascular risk factors associated with obesity," stated Dr. Grinspoon.

"These findings are very encouraging, particularly as we anticipate beginning human testing with our second generation growth hormone-releasing factor peptide, TH1173, early next year. The results of Dr. Grinspoon's study will help narrow down indications for future clinical trials," stated John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies.

Study Details

To assess the effects of augmenting GH secretion on body composition and cardiovascular risk factors, 60 obese patients with relative reductions in growth hormone (peak response to GH-releasing hormone (GHRH)-arginine testing ≤9 ug/L) were randomly assigned to a GHRH1-44 analogue, tesamorelin 2 mg SC QD or placebo for 12 months. Treatment effect was determined by longitudinal linear mixed effects modeling. 83% of subjects completed 6 months and 62% 12 months, without differences in discontinuation rates between the groups. Abdominal VAT, cIMT, logCRP, and triglycerides improved significantly in the tesamorelin group versus placebo. Results show that the changes amounted to a 19% reduction in visceral fat, 6% reduction in cIMT and 20% reduction in triglycerides in the tesamorelin group, relative to changes in the placebo group. No significant effects on abdominal SAT were seen. Mean IGF-1 levels increased by 90% in the tesamorelin group. No changes in fasting, 2-hour glucose or HbA1c were seen. There were no serious adverse events in both groups. The most commonly reported adverse events were hypertension (tesamorelin, n=8; placebo, n=5; p=0.27), hyperglycemia (tesamorelin, n=3; placebo n=2; p=0.70), tingling/paresthesia (tesamorelin, n=3; placebo n=1; p=0.33) and peripheral edema (tesamorelin, n=3; placebo, n=1; p=0.33). However, none of these differences were statistically significant.

 
 
 
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