Swedish pharmaceutical company Moberg Pharma AB (OMX: MOB) revealed on Tuesday that MOB-015 (topical terbinafine) has not met the primary endpoint in a phase 3 study with eight weeks of daily dosing followed by weekly maintenance dosing in patients with onychomycosis, a fungal infection that mainly affects toenails.

The company said that it will now focus on the effective daily dosing regimen approved in 13 EU countries.

The North American phase 3 study at 33 study centres in the US and Canada included a total of 384 patients, with 260 patients receiving MOB-015 and 124 patients receiving vehicle. This study differs from earlier studies with MOB-015, which is the basis for drug approval in 13 EU countries, by reducing the dosage -- eight weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the complete treatment period.

Bayer Consumer Health has conducted an extensive review on its pipeline and decided to stop the upcoming launch of MOB-015 due to strategic reasons and the topline data received. Therefore, Bayer and Moberg Pharma have expressed a mutual intent to terminate the licence agreement whereby Moberg Pharma regains the full rights for MOB-015 in the EU and retains milestone revenues already paid by Bayer.