Theratechnologies Inc., a specialty pharmaceutical company, engages in the discovery and development of therapeutic peptide products with a focus on growth-hormone releasing factor (GRF) peptides. Its primary product is EGRIFTA (tesamorelin for injection), an approved therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, which is marketed in the United States, Latin America, Africa, the Middle East, Europe, Russia, South Korea, Taiwan, and Thailand. The company is also conducting a Phase 2 study of tesamorelin for the treatment of muscle wasting in chronic obstructive pulmonary disease. In addition, it is developing compounds for the treatment of acute kidney injury and certain cancers. The company was founded in 1993 and is headquartered in Montreal, Canada.
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Theratechnologies Inc. announced that John-Michel T. Huss will be leaving his role as president and chief executive officer and as director of the company, effective immediately. On an interim basis, Luc Tanguay, senior executive vice president and chief financial officer, will fulfill the duties of president and chief executive officer. Mr. Tanguay has been a member of the management team since 1996 and a member of the Board of Directors since 1993.
Theratechnologies Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended August 31, 2012. For the quarter, the company reported total revenues of CAD 3,822,000 compared to CAD 3,517,000 a year ago. Negative results from operating activates was CAD 896,000 compared to CAD 4,644,000 a year ago. Net loss before income taxes was CAD 685,000 compared to CAD 4,201,000 a year ago. Net loss was CAD 698,000 or CAD 0.01 per basic and diluted share compared to CAD 4,170,000 or CAD 0.07 per basic and diluted share a year ago. Cash generated from operating activates was CAD 491,000 compared to cash used in operating activates of CAD 9,175,000 a year ago. For the nine months period, the company reported total revenues of CAD 9,668,000 compared to CAD 10,518,000 a year ago. Negative results from operating activates was CAD 10,330,000 compared to CAD 16,821,000 a year ago. Net loss before income taxes was CAD 9,585,000 compared to CAD 16,140,000 a year ago. Net loss was CAD 9,599,000 or CAD 0.16 per basic and diluted share compared to CAD 16,043,000 or CAD 0.26 per basic and diluted share a year ago. Cash used in operating activates was CAD 11,878,000 compared to CAD 24,896,000 a year ago. Acquisition of property, plant and equipment was CAD 69,000 compared to CAD 182,000 a year ago.
Theratechnologies Inc. provided an update 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. 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. 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. 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 the company expect sanofi to resubmit the file in due course. As a result, the review process will then begin anew.
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