Novavax files for Estrasorb approval in USA

Novavax has filed for approval to market its topical estrogenreplacement therapy, Estrasorb (17-beta-estradiol), for the treatment of symptoms associated with the menopause, in the USA. Phase III results indicate that Estrasorb is significantly superior to placebo treatment in reducing the number of hot flashes suffered by women in the trial.

The product is licensed to King Pharmaceuticals and, at the same time as the US submission, Novavax reported that it has expanded its exclusive license with King to promote, distribute and market Estrasorb worldwide, except in the USA and Puerto Rico, where the parties will co-market the drug. Under the terms of the revised deal, Novavax will receive $3 million in upfront payments, with an additional $3 million due on approval of the drug in Canada and its first European market.