Ferrer begins second Phase III study for Ozenoxacin

Ferrer, a privately-help Spanish pharmaceutical company, licensed US rights for Ozenoxacin to Medimetriks earlier this year.

The multicenter, randomized, double-blinded, clinical study compares Ozenoxacin 1% cream versus placebo. The study will be conducted in more than 400 patients 2 months and older with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centers in the United States, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals.

The study is expected to be completed in the first quarter of 2015. Further details will be available at http://www.clinicaltrials.gov.

In 2013, Ferrer successfully completed the first Phase III Clinical Trial of Ozenoxacin in adult and pediatric patients with impetigo. The study demonstrated the superiority of Ozenoxacin, applied topically twice daily for five days, versus placebo on both the clinical and bacteriological endpoints by the end of therapy.

In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo, typically by day 4. Ozenoxacin was shown to be very well tolerated in both adult and pediatric populations.

In preclinical in vitro and in vivo studies, Ozenoxacin has shown excellent antibacterial activity against a broad range of bacteria, including organisms with emerging resistance to other commonly prescribed topical antibiotics.

"Impetigo due to bacterial skin infections is a common problem, especially in infants and young children," said Fernando Garcia Alonso, Chief Scientific Officer at Ferrer.

"The emergence of treatment-resistant bacterial pathogens underpins the need for alternative agents, such as Ozenoxacin. The clinical studies performed by Ferrer with Ozenoxacin aim to provide patients with impetigo an alternative, safe and effective topical antibacterial treatment. In addition, Ozenoxacin could potentially represent a topical treatment for a broad range of other infectious dermatological conditions."

"Ozenoxacin is on track to complete its phase III study and eventual NDA filing," stated Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks. "We are excited about the potential for Ozenoxacin to help Dermatologists and their patients with impetigo. We are committed to partnering with the Dermatology community to develop new treatments for unmet medical needs, and Ozenoxacin is an example of this commitment."