Mr. Shawn O'Brien reports

CIPHER PHARMACEUTICALS ANNOUNCES SUCCESSFUL COMPLETION OF SECOND PHASE III FOR OZENOXACIN

Ferrer International SA has successfully completed the second phase III clinical trial for Ozenoxacin, a topical treatment for adult and pediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher Pharmaceuticals Inc. 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 chief executive officer of 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 pediatric patients aged two months and older, demonstrated the superiority of Ozenoxacin 1-per-cent cream, applied twice daily for five days, versus placebo on both the clinical and bacteriological end points by end-of-therapy visit (days six to seven). In addition, Ozenoxacin 1-per-cent cream demonstrated superior bacteriological cure compared with placebo as early as visit two (days three to four). Ozenoxacin 1-per-cent cream was shown to be safe and very well tolerated in the adult and pediatric population.

The trial was conducted at 44 centres in the United States, Puerto Rica, South Africa, Germany, Romania, Russia and Spain and involved 412 adult and pediatric patients aged two 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 pediatric patients aged two years and older with impetigo, in which Ozenoxacin demonstrated superiority on both clinical and bacteriological end points to placebo by end-of-therapy visit (days six to seven) and a more rapid microbial clearance than placebo and retapamulin at visit two (days three to four) (reference: Future Microbiol (2014) 9(9), pages 1013 to 1023).

Ferrer expects a first regulatory filing of Ozenxacin in Europe in the first quarter of 2016 and expects its U.S. licence partner to file for U.S. regulatory approval also in the first quarter of 2016.

About impetigo

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 United States, impetigo is estimated to account for approximately 10 per cent of the skin problems observed in pediatric 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. 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.

About Ozenoxacin

Ozenoxacin belongs to a new generation of non-fluorinated quinolones. It is undergoing clinical development, formulated as a topical 1-per-cent cream, for dermatological infections. The bactericidal action of Ozenoxacin has resulted in an excellent in vitro and in vivo anti-bacterial 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 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 pediatric patients aged two years and older with impetigo (reference: Future Microbiol (2014) 9(9), pages 1013 to 1023). Extensive preclinical and clinical studies conducted in healthy subjects and adult and pediatric patients (aged two 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 anti-bacterial products is approximately $800-million (U.S.) per year.

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