- Company expects to submit Ozenoxacin for regulatory approval in Canada in the first quarter of 2016 -
MISSISSAUGA, ON, July 30, 2015 /CNW/ - Cipher Pharmaceuticals Inc. (NASDAQ: CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that Ferrer International SA ("Ferrer") successfully completed the second phase III clinical trial for Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer, a privately-held Spanish pharmaceutical company, in January 2015.
"The successful completion of the second phase III trial for Ozenoxacin moves us one step closer to an alternative treatment for one of the most common bacterial skin infections in children worldwide, amidst the emergence of treatment resistant bacterial pathogens," said Shawn Patrick O'Brien, President and CEO, Cipher Pharmaceuticals. "We look forward to the regulatory submission to Health Canada anticipated for the first quarter of 2016."
The study, which involved Ozenoxacin formulated as a topical treatment for dermatological infectious conditions in adults and peadiatric patients aged 2 months and older, demonstrated the superiority of Ozenoxacin 1% cream, applied twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7). In addition, Ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4). Ozenoxacin 1% cream was shown to be safe and very well tolerated in the adult and paediatric population.
The trial was conducted at 44 centres in the United States, Puerto Rico, South Africa, Germany, Romania, Russia, and Spain, and involved 412 adult and paediatric patients aged 2 months and older with a clinical diagnosis of bullous or non-bullous impetigo.
In 2013 Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged 2 years and older with impetigo in which Ozenoxacin demonstrated superiority on both clinical and bacteriological endpoints to placebo by end of therapy visit (days 6-7) and a more rapid microbial clearance than placebo and retapamulin at visit 2 (day 3-4), ref: Future Microbiol (2014) 9(9), 1013 - 1023.
Ferrer expects a first regulatory filing of Ozenxacin in Europe in the first quarter of 2016 and expects their U.S. license partner to file for U.S. regulatory approval also in the first quarter of 2016.
Impetigo is a highly contagious bacterial skin infection. It affects most commonly 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 ~10% 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 (70% 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 1% cream, for dermatological infections. 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 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 phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs) and a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged 2 years and older with impetigo, ref: Future Microbiol (2014) 9(9), 1013 - 1023. Extensive preclinical and clinical studies conducted in healthy subjects and adult and paediatric patients (aged 2 months and older), have demonstrated that 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.
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 US$600M per annum.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (NASDAQ: CPHR; TSX:CPH) is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products with the goal of becoming the most customer-centric dermatology company in North America.
Cipher has completed seven transactions in 2015, including the acquisition of Innocutis and its seven branded dermatology products, to build its U.S. commercial presence, expand its Canadian dermatology franchise and broaden its pipeline. Cipher is well-capitalized to drive long-term, sustained earnings growth by leveraging its proven clinical development capabilities and efficient commercial execution. For more information, visit www.cipherpharma.com.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. 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. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. www.ferrer.com
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SOURCE Cipher Pharmaceuticals Inc.
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