Medicis/Q-Med
This article was originally published in The Gray Sheet
Executive Summary
Medicis gains aesthetic dermal filler product line's exclusive U.S. and Canadian market rights for $160 mil., including $58.2 mil. up front, $53.3 mil. upon FDA approval of Restylane for facial wrinkles, $29.1 mil. upon U.S. approval of Perlane for lips and deep folds, and $19.4 mil. "upon certain cumulative commercial milestones," skin drug maker says. Swedish firm Q-Med expects a June 2002 PMA application for Restylane to be approved by July; a submission for Perlane will be made upon Restylane approval. The company, which remains responsible for regulatory submissions, markets the hyaluronic acid (HA)-based products in over 60 countries outside the U.S. and will retain North American manufacturing rights for 10 years. The firm's Deflux HA gel was approved via PMA for pediatric vesicoureteral reflux in September 2001 (1"The Gray Sheet" Oct. 8, 2001, p. 27)...