The distributing and licensing deal was inked between an affiliate of Sanofi and Theratechnologies on 6 December 2010.
Under the agreement, Sanofi has been licensed commercialization rights for tesamorelin as a treatment for excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East.
The registration application was supported by the positive results from two Phase 3 trials which involved around 800 patients.
Theratechnologies president and CEO John-Michel Huss said this marks the first regulatory filing in the Middle East for Theratechnologies’ tesamorelin compound, and they are pleased to expand their product’s footprint with their partner Sanofi.
"We look forward to working with them throughout this regulatory process and in other countries where Sanofi has exclusive commercialization rights for tesamorelin," Huss said.