Bad news about Egrifta's Manufacturer

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 Theratechnologies Provides Regulatory Update on Tesamorelin http://www.theratech.com/

http://www.theratech.com/sites/default/files/news_release_en/th-06222012-en.pdf

 MONTREAL, QUEBEC, Jun 22, 2012 (MARKETWIRE via COMTEX) -- 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.  

-- Regards, VergelBooks