FAIRFIELD, N.J., July 30, 2015 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that its licensor, Ferrer, completed the second Phase III clinical study for Ozenoxacin, a novel bactericidal non-fluorinated quinolone in development for impetigo. Medimetriks owns the exclusive U.S. rights to Ozenoxacin 1% cream.
The global trial, conducted at 44 centers with an emphasis on U.S. patients, involved 412 adult and pediatric patients aged 2 months and older with a clinical diagnosis of bullous or non-bullous impetigo. The study demonstrated the superiority of Ozenoxacin 1% cream, applied topically twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints by the end of therapy (day 6-7). Ozenoxacin 1% cream also demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4), and was shown to be safe and very well tolerated in both the adult and pediatric populations. Medimetriks intends to submit a New Drug Application to FDA for Ozenoxacin 1% cream during the First Quarter 2016.
The first Phase III clinical study in adult and pediatric patients with impetigo was successfully completed by Ferrer In 2013. Preclinical in vitro and in vivo studies with Ozenoxacin showed 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 remains a common problem worldwide, especially in infants and young children living in warm, humid climates," said Fernando Garcia Alonso, Chief Scientific Officer at Ferrer. "The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined market value approaching $600 million per year."
"We are encouraged about the results from the second pivotal Phase III trial and we are planning for the eventual approval and successful commercialization of Ozenoxacin," stated Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks. "Ozenoxacin represents an important example of our partnership with Dermatology and our commitment to offer patients new treatments for unmet dermatologic needs. We expect our pace of investments in Dermatology to increase."
Impetigo is a highly contagious bacterial skin infection. It most commonly affects infants, young children and those involved in close contact sports or living in enclosed environments. In the USA, impetigo is estimated to account for approximately 10% of the skin problems observed in pediatric clinics. It is also considered the most common bacterial skin infection and third most common skin condition of children.
Ozenoxacin 1% cream belongs to a new generation of non-fluorinated quinolones. The bactericidal action of Ozenoxacin has resulted in excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics. Ozenoxacin may represent a first-in-class non-fluorinated quinolone treatment option for the topical treatment of a broad range of infectious dermatological conditions.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 90 countries, with 23 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics.
For more information, please visit: www.ferrer.com
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands. The Company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care.
For more information, please visit: www.medimetriks.com
Contact: David Addis
Senior Vice President, Brand Communication
Medimetriks Pharmaceuticals, Inc.
(973) 882-7512, ext. 569
SOURCE Medimetriks Pharmaceuticals, Inc.