Cipher Pharmaceuticals Inc, a growing specialty pharmaceutical company that commercialises novel formulations of successful, currently marketed molecules, has licensed the Canadian rights to Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, from Ferrer, a privately-held Spanish pharmaceutical company.
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and older with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, 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 (for details see Future Microbiol (2014) 9(9), 1013 - 1023).
Ferrer commenced a second phase III trial of Ozenoxacin in June 2014. The multicenter, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in approximately 412 patients aged two months and older with a clinical diagnosis of non-bullous or bullous impetigo. Ferrer anticipates that the second phase III trial will be completed by the end of Q1 2015.
"We are pleased to partner with Ferrer to bring this novel product to the Canadian market, targeting impetigo due to bacterial skin infections, which remains a common problem in infants and young children," said Shawn O'Brien, president & chief executive officer of Cipher. "Expanding our Canadian dermatology franchise is a key strategic priority for us, and we believe Ozenoxacin has high potential in the topical impetigo market."
Under the terms of the agreement, Ferrer will receive an upfront payment and is eligible for development milestones and revenues from product sales in Canada. Ferrer will manufacture Ozenoxacin and deliver finished product to Cipher.
Impetigo is a very common and highly contagious bacterial skin infection. Although it can affect anyone, it is most often found in preschool-aged 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 and 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 as a topical one per cent cream for acute dermatological infections. The bactericidal action of Ozenoxacin has demonstrated excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including methicillin-resistant Staphylococcus aureus 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.