Supplier News Breaks Archives
Actavis, Valeant cleared to market Metronidazole 1.3%
March 26th, 2014
DUBLIN, Ireland, and LAVAL, Quebec – Actavis plc and Valeant Pharmaceuticals International Inc. have received approval from the Food and Drug Administration for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV).
The companies said Tuesday that Metronidazole 1.3% provides a convenient, single-dose treatment for BV that is packaged in a prefilled, disposable applicator. It is adminstered once intravaginally at bedtime.
An infection caused by an imbalance in the normal bacteria in the vagina, BV is the most common vaginal infection in women ages 15 to 44, according to Actavis and Valeant. The U.S. BV market is valued at approximately $140 million annually, based on IMS Health data reported by Actavis and Valeant.
"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," stated Fred Wilkinson, president of 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."
Actavis acquired the rights to Metronidazole 1.3% from Valeant in April 2013.
"Valeant is pleased that another internal R&D compound has been approved by the FDA and will soon be available," commented Tage Ramakrishna, chief medical officer for Valeant Pharmaceuticals. "Metronidazole 1.3% gives health care providers and women a new safe and effective treatment for bacterial vaginosis."
Under the agreement with Valeant, Actavis will acquire the rights to Metronidazole 1.3% for up to $57 million in up-front payments, milestone payments and certain guaranteed royalty payments during the first three years of commercialization, depending on market conditions, the companies said. Actavis will also pay ongoing royalties to Valeant after the first three years of commercialization.