Q-Med Breaks Into U.S. Urology Market With Deflux Pediatric VUR Indication
This article was originally published in The Gray Sheet
Executive Summary
Q-Med plans to begin a U.S. pilot study of its Deflux injectable hyaluronic gel product for treatment of stress urinary incontinence early in 2002. The product has been available in Europe for the indication since 1999.
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Medicis/Q-Med
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)...
Medicis/Q-Med
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)...
Q-Med U.S. Postmarket Study Needed To Support Deflux Efficacy - Panel Says
Q-Med AB should conduct a prospective, randomized, multi-center study in the U.S. of its Deflux injectable gel for vesicoureteral reflux in children as a postmarket condition for FDA approval, FDA's Gastroenterology and Urology Devices Panel recommended.