IntelGenx eyes FDA nod with anti-migraine film results

Canadian drug delivery company IntelGenx Technologies ($IGXT) is optimistic that it can get its VersaFilm platform on the market, touting positive trial results for a formulation of Merck's ($MRK) migraine drug Maxalt.

VersaFilm is a quick-dissolving oral delivery platform, and its latest trial, a two-way crossover study, demonstrated that it is safe and bioequivalent with the tablet formulation of Maxalt. "With the successful completion of the pivotal study, the most critical hurdle toward obtaining FDA approval for the product has been overcome and another significant milestone in the development and commercialization process of our most advanced VersaFilm product has been achieved," IntelGenx CEO Horst Zerbe said in a statement.

The company is developing a few applications for VersaFilm, and the Maxalt formulation is the furthest along in the approval process. And the company has reason for excitement: According to Merck's last annual report, sales of Maxalt tablets grew 16% to $639 million in 2011. IntelGenx is confident that the VersaFilm platform will cash in with patients who struggle to swallow tablets due to migraine-induced nausea. The company said it will file an FDA application as soon as it can provide sufficient stability data on the formulation.

IntelGenx has a commercialization deal with Israel's RedHill Biopharma, reached in 2010, which allows that company to market VersaFilm in parts of the world in exchange for up to 70% of the resulting profits.

- read IntelGenx's release