Date: 2015-01-07
Type of information: Licensing agreement
Compound: ozenoxacin
Company: Ferrer (Spain) Cipher Pharmaceuticals (Canada)
Therapeutic area: Infectious diseases - Dermatological diseases
Type agreement: licensing
Action mechanism: Ozenoxacin belongs to a new generation of non-fluorinated quinolones. It is undergoing clinical development, formulated as a topical one per cent cream, for infectious dermatological conditions. Ozenoxacin acts via potent dual inhibition of DNA gyrase and topoisomerase IV. The bactericidal action of ozenoxacin has resulted in an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including against Methicillin resistant strains of Staphylococcus aureus and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics. Ferrer obtained exclusive worldwide rights (except China, Japan, Korea and Taiwan) to Ozenoxacin from Toyama.
The clinical efficacy of topical ozenoxacin cream has previously been demonstrated in a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs). Extensive preclinical and clinical studies (Phase I & II, in around 1,000 subjects) have demonstrated topically formulated ozenoxacin is safe and well tolerated, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones, such as photoirritation reactions, sensitization potential or photoallergic reactions.
Disease: impetigo
Details: * On January 7, 2015, Ferrer, a privately-held Spanish pharmaceutical company, announced that it has licensed commercialisation rights for Ozenoxacin one per cent cream in Canada to Cipher Pharmaceuticals. 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. This is the second licensing agreement for Ferrer for ozenoxacin. In March 2014, Ferrer licensed commercialisation rights for ozenoxacin one per cent cream in the USA, Puerto Rico and the US Virgin Islands to Medimetriks Pharmaceuticals Inc. In 2013 Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients with impetigo. 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 (Future Microbiol (2014) 9(9), 1013 - 1023).
Financial terms: Financial terms were not disclosed.
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