Theratechnologies CEO John-Michel T. Huss. The company today announced that Health Canada is now reviewing tesamorelin, and expects to receive a decision within 150 days.
In Canada, the company said that, together with its commercial partner in the country, Actelion Pharmaceuticals, it responded to additional questions Health Canada had regarding the long-term safety of the drug.
Health Canada is now reviewing the new drug submission, and Theratechnologies expects to receive a decision within 150 days.
In Latin America, the company said that it and its partner in the region, Sanofi, have been able to address “all technical deficiencies” identified by Brazil’s National Health Surveillance Agency, following an audit of its Montreal-based third party manufacturing site in June.
The corrective measures proposed by the regulatory body, and agreed to by the third-party manufacturer, are now being implemented, the drug maker said.
The company noted that the evaluation of the Brazilian marketing application is a separate process, which is being conducted in parallel with the manufacturing assessment.
In Venezuela, the company was advised that its filing made in June of this year was incomplete for technical reasons, and it expects Sanofi to resubmit in “due course”. The review process here, will, as a result, start fresh.
Meanwhile, in Europe, following the withdrawal of the marketing authorization application for the drug in the summer, Theratechnologies says it continues to “actively assess and evaluate” various options to resubmit an application in this region.
This process is ongoing, with no firm timelines available as of this date, it added. Any new submission will be covered by a 10-year exclusivity period if approved.
The specialty pharmaceutical company discovers and develops therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Shares in the company in Toronto rose more than 4 per cent to 50 cents late morning Wednesday.
Deborah Bacall
Proactive Investors
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