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Medimetriks Pharmaceuticals, Inc. Submits a New Drug Application to FDA for Ozenoxacin Cream, 1%, a Novel Impetigo Treatment

Shanghai Biopharmaleader Co.,Ltd | Updated: Jun 28, 2016


FAIRFIELD, NJ, USA I June 27, 2016 I Medimetriks Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ozenoxacin cream, 1%, a novel, non-fluorinated quinolone for the treatment of impetigo.  Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a leading, privately held Spanish pharmaceutical company, in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015.   

Both Phase 3 pivotal studies demonstrated the superiority of ozenoxacin cream, 1%, applied topically twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints. In the studies, ozenoxacin demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4), and showed excellent antibacterial activity against a broad range of bacteria.  The studies demonstrated that ozenoxacin was safe and well tolerated in both the adult and pediatric populations aged 2 months and older. 

'Impetigo is a common, highly contagious bacterial skin infection that affects millions of children and adults in the United States each year,' said Dr. Theodore Rosen, Professor of Dermatology at Baylor College of Medicine. 'Given ozenoxacin's positive efficacy data and Dermatologist's concerns about emerging resistance to current treatments, ozenoxacin has the potential to offer patients a safe and effective option that could fulfill an important need in Dermatology.' 

'We believe that ozenoxacin has the potential to be an important treatment for patients suffering from impetigo,' stated Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks.  'The submission of the ozenoxacin NDA is a significant milestone for Medimetriks as we deliver innovation to Dermatology and address patient's unmet skin care needs.  We look forward to working with the FDA in its review of ozenoxacin.'

About Impetigo
Impetigo, a highly contagious bacterial skin infection commonly treated by Dermatologists and Pediatricians, most often affects infants, young children and those involved in close contact sports or living in enclosed environments. In the U.S., impetigo is estimated to account for approximately 10% of the skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.  The impetigo market has few contemporary treatments available and generates more than 8 million prescriptions annually.

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