Theratechnologies regains commercialization rights of EGRIFTA in Canada

It is indicated for the treatment of excess visceral adipose tissue, as evaluated by waist circumference = 95 cm for men and = 94 cm for women, and confirmed by a visceral adipose tissue (VAT) level > 130 cm2 by CT scan, in treatment-experienced adult HIV-infected patients.

The company will file a supplementary new drug submission (sNDS) with Health Canada to secure authorization to commercialize EGRIFTA’s 1mg/vial presentation as part of its earlier plan to continue production of the drug.

Initially, EGRIFTA was approved by the US Food and Drug Administration in November 2010 and since then hundreds of patients have been treated with the drug in the country.

The approval comes as the company completed discussions with Actelion Pharmaceuticals Canada (Actelion) to regain marketing rights in Canada.

Both the firms have entered into a termination agreement in April 2014, pursuant to which the company regained all rights under the supply, distribution and licensing agreement entered into in February 2012 (Original Agreement).

Consistent with the terms of the Original Agreement pursuant to which no upfront payment was made by Actelion to the company, the termination agreement does not provide for financial compensation to any of the parties involved.

As a result, the company will develop its own marketing strategy for Canada which will benefit from key learning experience in the US.

Theratechnologies president and CEO Luc Tanguay said after regaining all commercialisation rights for EGRIFTA (tesamorelin for injection) in the US, we came to the conclusion that it would be desirable and preferable for the company to assume all commercialisation activities in Canada.

"As we develop and implement our marketing plan in Canada, we will benefit from synergies stemming from our operations in the United States, and maximise the potential value of that territory for our shareholder," Tanguay said.