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Ferrer Internacional Initiates Phase III Clinical Studies for Novel Antibacterial Compound, Ozenoxacin, in Development as a Topical Treatment for Impetigo and Other Infectious Dermatological Conditions


1/19/2012 10:27:03 AM

Barcelona, Spain, 19 January 2012 - Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to distribution, today announced that it has received approval to initiate phase III clinical trials of ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to complete in the first quarter, 2013.

The multicenter, randomised, placebo controlled, parallel, double-blinded, superiority clinical study, comparing ozenoxacin one per cent cream versus placebo will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous impetigo at approximately 50 centres in the USA, South Africa, Germany, Romania, India and the Ukraine, subject to completion of additional regulatory approvals.

Ozenoxacin is a novel second generation non-fluorinated quinolone antibacterial agent undergoing clinical development, formulated as a topical one per cent cream, for infectious dermatological conditions. In preclinical studies, the bactericidal action of ozenoxacin (via potent dual inhibition of DNA gyrase and topoisomerase IV) has been shown to confer an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including clinical isolates of organisms with emerging resistance to quinolones and other commonly prescribed topical antibiotics.

The clinical efficacy of topical ozenoxacin cream has been demonstrated in a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs). Topical ozenoxacin has proven to be safe and well tolerated in clinical trials involving almost 1,000 subjects, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones.

Ferrer obtained exclusive worldwide rights to ozenoxacin (except China, Japan & Taiwan) from Toyama. Ozenoxacin formulated as a one per cent topical cream is the subject of a number of granted and pending patent applications. The product is available for licensing worldwide from Ferrer, except in China, Japan and Taiwan.

About impetigo

Impetigo is a highly contagious bacterial skin infection. It is most commonly found amongst infants, young children and those involved in close contact sports or living in enclosed environments, it is not common in adults. 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 (http://en.wikipedia.org/wiki/infection) is transmitted between individuals by direct contact with lesions (http://en.wikipedia.org/wiki/lesion), with nasal (http://en.wikipedia.org/wiki/human_nose) carriers or sharing of towels etc.

There are two types of impetigo: bullous, which causes large, painless, fluid-filled blisters, and non-bullous, which is more contagious than the former and causes sores that quickly rupture to leave a yellow-brown crust. Both the bullous (http://en.wikipedia.org/wiki/bullous) and non-bullous forms of impetigo are primarily caused by staphylococcus aureus, with streptococcus pyogenes also commonly involved in the non-bullous form.

About ozenoxacin

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. 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.

Extensive preclinical and clinical studies (Phase I & II, in approximately 1,000 subjects) have demonstrated topically formulated ozenoxacin is both efficacious, 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.

Ozenoxacin could represent a first-in-class treatment option (best-in-class quinolone) for the topical treatment of a broad range of infectious dermatological conditions, including those due to staphylococcus aureus and streptococcus pyogenes, the most commonly encountered pathological causes of impetigo.

In addition to development in impetigo and other dermatological conditions, ozenoxacin is being assessed for its potential to be developed in a variety of systemic indications, such as bone and joint infections and pulmonary infections.

About Ferrer

Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. 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.

Since the beginning, Ferrer has been committed to the research and development of innovative medicinal products in its six R&D centres (four in Spain) and to a solid industrial structure, with thirteen manufacturing centres (seven in Spain). This research and manufacturing capacity covers the pharmaceutical, diagnostics, vaccines, fine chemical, food and feed sectors.

In recent years, it has concentrated on diversifying across the whole healthcare spectrum, including prescription drugs, hospital products, molecular diagnostics, OTC and self-care. This diversification goes hand in hand with the setting-up and consolidation of strategic alliances.

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.ferrergrupo.com

For licensing enquiries, please contact

Stephen Harris, PhD

Research Assets Development

sharris-research@ferrergrupo.com

Mark Tidmarsh

ANDREW LLOYD & ASSOCIATES

http://www.ala.com

mark@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND

Tel: +44 1273 675100 Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE

Tel: +33 1 56 54 07 00 Fax: +33 1 56 54 07 01

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