Ferrer, a privately-held Spanish pharmaceutical company today announces that it has licensed commercialisation rights for Ozenoxacin one per cent cream in the United States of America, Puerto Rico and the U.S. Virgin Islands to Medimetriks Pharmaceuticals Inc. Under the terms of the agreement Ferrer will be eligible to receive development milestones and revenues from sales in the Medimetriks territory.
In 2013 Ferrer successfully completed a first phase III clinical trial in adult and paediatric patients with impetigo. This involved Ozenoxacin formulated as a topical treatment for dermatological infectious conditions. The study demonstrated the superiority of Ozenoxacin one per cent cream, applied topically twice daily for five days, versus a placebo on both the clinical and bacteriological endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.
“We are proud to partner with Ferrer to maximize the commercialization of Ozenoxacin in the United States,” said Bradley Glassman, Medimetriks Chairman and Chief Executive. “We are committed to investing in the future of dermatology and ensuring that the dermatology community and its patients have new ways to treat unmet medical needs. Ozenoxacin is an example of our commitment. We expect our pace of investments in dermatology to increase.”
“Impetigo due to bacterial skin infections remains 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 infants and others with impetigo an alternative, safe and effective topical antibacterial treatment. In addition, Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions.”
The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea, Taiwan and the Medimetriks territory.
About the second phase III study
The trial is a double-blind, randomized, placebo-controlled study to assess the efficacy and safety of Ozenoxacin one per cent cream applied topically twice daily for five days in the treatment of patients with impetigo (aged two months and above). The main objectives of the study are to evaluate the clinical and microbiological response to Ozenoxacin compared to a placebo. The trial is anticipated to be initiated in the second quarter of 2014. It will involve approximately 412 patients at 36 centres in 7 countries (further details will be made available at http://www.clinicaltrials.gov).
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. It is not common in adults. In the USA, impetigo is estimated to account for approximately ten per cent of the skin problems observed in paediatric clinics. It is also considered the most common bacterial skin infection and third most common skin condition in children.
The condition usually manifests itself as blisters or sores on the face, neck, hands and trunk. Scratching may spread the lesions to other parts of the body. The infection is transmitted between individuals by direct contact with lesions, with nasal carriers or sharing of towels etc.
There are two types of impetigo: bullous, which causes large, painless, fluid-filled blisters and non-bullous (70 per cent of cases), which is more contagious and causes sores that quickly rupture to leave a yellow-brown crust. Both the bullous and non-bullous forms of impetigo are primarily caused by Staphylococcus aureus, with Streptococcus pyogenes also commonly involved in the non-bullous form.
Ozenoxacin belongs to a new generation of non-fluorinated quinolones. It is undergoing clinical development, formulated as a topical one per cent cream, for dermatological infections. The bactericidal action of Ozenoxacin has resulted in excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including Staphylococcus aureus Methicillin resistant strains and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics.
The clinical efficacy of topical Ozenoxacin cream has previously been demonstrated in a first phase III study in impetigo patients, as well as a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs). Extensive preclinical and clinical studies conducted in healthy subjects and adult and paediatric patients (aged two months and older) have demonstrated that topically formulated Ozenoxacin is efficacious, safe and well tolerated, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones.
Ferrer obtained exclusive worldwide rights (except China, Japan, Korea and Taiwan) to Ozenoxacin from Toyama. Ozenoxacin formulated as a one per cent topical cream is the subject of a number of granted and pending patent applications.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 90 countries, with 27 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-infective, immunology, diagnostics, OTC and dermocosmetics.
For more information, visit: http://www.ferrer.com
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc., founded in 2008 as a specialty pharmaceutical company; develops, licenses and commercializes prescription skincare products with a focus on dermatology and select specialty markets. The company mission is to enhance patient quality-of-life by providing innovative therapies that advance patient care.
For more information, please visit: http://www.medimetriks.com