Company news: Endo Pharmaceuticals and MannKindEndo Pharmaceuticals said it received FDA approval for a testosterone gel called Fortesta. It's the second topical testosterone product in as many months to win US approval, and one which could achieve several hundred million dollars in sales, according to one analyst. “Fortesta will be the highest concentration gel (2%) on the market and [its] smaller application site should be more convenient,” wrote Collins Stewart analyst Louise Chen in an investor note. “It also has a faster drying time than [Solvay's] AndroGel (2 hours versus 5 to 6 hours). The market leaders Testim [Auxilium] and AndroGel are only 1% concentration and have annual sales of $211MM and $885MM, respectively, according to IMS.” She added that testosterone replacement therapy is a $1.2 billion market, with topical gels accounting for 60%. Endo's gel is designed to be applied to the front and inner thighs. In November, Eli Lilly won approval for a 2% alcohol-based solution called Axiron, which is applied under the arms and is also intended for men with hypogonadism. Endo is expected to launch Fortesta to PCPs and to certain urologists and endocrinologists in early 2011.
Yesterday's FDA action date for inhalable insulin Afrezza came and went, after the agency notified MannKind that it will need about four more weeks to review the NDA. MannKind resubmitted its Afrezza application in July, a few months following a Complete Response Letter in which the FDA requested more information on how available data support the clinical utility of Afrezza in the marketplace.