Actavis plc and Valeant Pharmaceuticals International Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV). Actavis acquired the rights to Metronidazole 1.3% from Valeant Pharmaceuticals International in April 2013.
Bacterial vaginosis is an infection caused by an imbalance in the normal bacteria in the vagina. It is the most common vaginal infection in women ages 15 to 44[i]. Metronidazole 1.3% provides a convenient, single-dose treatment for BV that is packaged in a pre-filled disposable applicator. The U.S. BV market is valued at approximately $140 million annually, according to IMS Health.
“The approval of Metronidazole 1.3% is a significant milestone for Actavis and provides an important new option with a single-dose treatment for women suffering from BV,” said Fred Wilkinson, president, Actavis Global R&D. “The expected launch of the product later this year will establish a promising long-term opportunity for Actavis and support the continued growth of our industry-leading Women’s Health franchise.”
“Valeant is pleased that another internal R&D compound has been approved by the FDA and will soon be available,” said Tage Ramakrishna, chief medical officer, Valeant Pharmaceuticals. “Metronidazole 1.3% gives health care providers and women a new safe and effective treatment for bacterial vaginosis.”
Under terms of the agreement with Valeant, Actavis will acquire the rights to Metronidazole 1.3% for up to $57 million in upfront payments, milestone payments and certain guaranteed royalty payments during the first three years of commercialization, depending on market conditions. Actavis will also pay ongoing royalties to Valeant after the first three years of commercialization.
The approval of Metronidazole 1.3% was based on the results of a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial, which found that the higher concentration Metronidazole 1.3% was well tolerated, safe and efficacious. Metronidazole 1.3% provides an alternative treatment option to MetroGel-Vaginal (metronidazole vaginal gel 0.75%) for patients with bacterial vaginosis.
Date: March 25, 2014