Theratechnologies Inc.: Tesamorelin Filed for Marketing Authorization in Argentina
News Sep 02, 2011
Theratechnologies Inc. has announced that an affiliate of Sanofi, its commercial partner, has filed a marketing authorization application for tesamorelin in Argentina with the Ministry of Health's National Administration of Drugs, Foods and Medical Technology (ANMAT).
Tesamorelin is proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Theratechnologies estimates that there are approximately 13,000 HIV-infected patients suffering from excess abdominal fat in Argentina. Currently, there are no approved treatments available for this condition in South America.
"We are committed to maximizing the commercial potential of tesamorelin and this cannot be done without the efficient filing of regulatory applications in new markets. Through our partner, Sanofi, we are making great progress in this regard and we are very pleased," said Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies.
"Argentina and Brazil, where an application was also filed, represent important Latin American markets," concluded Mr. Huss.
Theratechnologies signed a distribution and licensing agreement with an affiliate of Sanofi on December 6, 2010, granting them exclusive commercialization rights for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East.
Additional applications for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy are currently under review with regulatory agencies in Europe, Brazil, Canada and Israel.
By leveraging an organ-on-a-chip model and a bioreactor, four human gut metabolites have been identified that can help explain the enhanced sensitivity of the human colon towards enterohemorrhagic E. coli, which is responsible for more than 100,000 infections per year in the USA alone.READ MORE