Actelion, Theratechnologies, Merck KGaA deal
The companies completed the return of U.S. rights to Egrifta tesamorelin to Theratechnologies from Merck's EMD Serono Inc. subsidiary. The analog of growth hormone-releasing factor is approved to treat excess abdominal fat in HIV patients with lipodystrophy (see BioCentury, Dec. 23, 2013).
Separately, Theratechnologies regained Canadian rights to Egrifta from Actelion. Theratechnologies said the termination agreement does not provide financial compensation to any parties involved. On April 30, Theratechnologies said Health Canada approved Egrifta to treat excess visceral adipose tissue. In November, Theratechnologies said that Health Canada agreed to resume review of an NDS for Egrifta. Last March, the application received a notice of non-compliance-withdrawal (NON/w), which concluded the risks of tesamorelin outweighed its benefits. The biotech said the decision to rescind the NON/w was based on recommendations contained in a report issued by a reconsideration panel (see BioCentury, Nov. 11, 2013). ...