Ferrer Successfully Completes An Absorption, Tolerability and Safety Study in Juveniles As Young As Two Months of Age for Novel Antibacterial Compound Ozenoxacin
Ozenoxacin, a novel bactericidal non-fluorinated quinolone, in development as a topical treatment for impetigo and other infectious dermatological conditions, is available for licensing and commercialisation from Ferrer
Barcelona, Spain, October 5, 2012 - Ferrer, a privately-held
Spanish pharmaceutical company with full vertical integration from
R&D to distribution, announces today that it has successfully
completed an absorption, tolerability and safety clinical trial in
adult and juvenile patients from two months of age with impetigo
involving Ozenoxacin formulated as a topical treatment for
infectious dermatological conditions.
The study, conducted at two centres in South Africa and involving
46 patients, demonstrated that topical Ozenoxacin was safe and well
tolerated in adults and juveniles aged 2 months - 18 years old,
with no significant evidence for systemic exposure.
This study will form the basis of a first regulatory filing for
Ozenoxacin in 2013, along with an on-going multicentre, randomised,
placebo controlled, parallel, double-blinded, superiority clinical
study, comparing Ozenoxacin one per cent cream versus placebo
involving about 465 patients more than two years old (there are now
over 360 patients enrolled) with a clinical diagnosis of
non-bullous or bullous impetigo. This study is being conducted at
approximately 50 centers in the USA, South Africa, Germany, Romania
and the Ukraine and is scheduled to complete in the first quarter,
2013.
Ozenoxacin is a novel non-fluorinated quinolone antibacterial agent
undergoing clinical development. The agent has been 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. Importantly, given the maturity
of other products in this field, these include clinical isolates of
organisms with emerging resistance to quinolones and 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 Antonio Guglietta, R&D director at
Ferrer. "The emergence of treatment resistant bacterial pathogens
underpins the need for alternative agents. Clinical studies being
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, with a combined market value approaching
USD 800 million per annum."
Ferrer obtained exclusive worldwide rights to Ozenoxacin (except
China, Japan, Korea and 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, Korea
and Taiwan.
About Impetigo
Impetigo is a highly contagious bacterial skin infection. It is
most commonly found amongst infants and young children living in
hot, humid climates, 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 of 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 (approximately 70
per cent of cases), which is more contagious than the former 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.
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.
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.
Ozenoxacin could represent a first-in-class non-fluorinated
quinolone 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 and other skin infections such as SITLs. The
worldwide market for topical antibacterial products is
approximately USD 800 million per annum.
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
https://twitter.com/ALA_Group
Brighton Forum 95 Ditchling Road Brighton BN 1 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
INTERNATIONAL TECHNOLOGY MARKETS, STRATEGY & COMMUNICATIONS
Posted: October 2012
