A first regulatory filing of Ozenoxacin, a novel bactericidal non-fluorinated quinolone, formulated as a 1% cream, is anticipated during Q1 2016
BARCELONA, Spain I July 30, 2015 I Ferrer, a privately-held Spanish pharmaceutical company, today announces that it has successfully completed a second phase III clinical trial in adult and paediatric patients aged two months and older with impetigo, utilizing Ozenoxacin 1% cream as a topical treatment for dermatological infectious conditions.
The study demonstrated the superiority of Ozenoxacin 1% cream, applied topically twice daily for five days, versus placebo, on both the clinical and bacteriological endpoints by the end of therapy (day 6-7). In addition, Ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit two (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. It involved 412 adult and paediatric patients aged two months and older with a clinical diagnosis of bullous or non-bullous impetigo. The first regulatory filing is anticipated during Q1 2016 in Europe by Ferrer, in the United States by Medimetriks Pharmaceuticals, Inc. and in Canada by Cipher Pharmaceuticals Inc.
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and older with impetigo. In this trial Ozenoxacin demonstrated superiority to placebo on both clinical and bacteriological endpoints by the end of therapy (day 6–7) and a more rapid microbial clearance than placebo and retapamulin at visit two (day 3–4), ref: Future Microbiol (2014) 9(9), 1013 – 1023.
Ferrer obtained exclusive worldwide rights to Ozenoxacin (excluding China, Japan, Korea and Taiwan) from Toyama. Ozenoxacin 1% topical cream is the subject of a number of granted and pending patent applications. The product is available for licensing worldwide from Ferrer excluding China, Japan, Korea, Taiwan, the United States and Canada.
“Impetigo due to bacterial skin infections remains a common problem worldwide, especially in infants and young children living in warm, humid climates,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined global market value approaching €540 million ($600M) per annum.”
About Impetigo
Impetigo is a highly contagious bacterial skin infection. It most commonly affects 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 around 10% of the skin problems observed in paediatric clinics. It is the most common bacterial skin infection and third most common skin condition of children.
The condition usually manifests as blisters or sores on the face, neck, hands and trunk. Scratching may spread the lesions to other parts of the body. 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.
About Ozenoxacin
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 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 two 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 two months and older) have demonstrated that topically formulated Ozenoxacin is efficacious, safe and well tolerated, exhibiting no dermal absorption and showing 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 global market for topical antibacterial products is approximately €540 million ($600M) per annum.
About Ferrer
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
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands in the United States. The company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care. Medimetriks owns the exclusive rights to Ozenoxacin for the US market. www.medimetriks.com
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. Cipher has completed seven transactions in 2015, including the acquisition of Innocutis and its seven branded dermatology products, to build its US 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. Cipher has the exclusive rights to Ozenoxacin for the Canadian market. www.cipherpharma.com.
SOURCE: Ferrer
Post Views: 39
A first regulatory filing of Ozenoxacin, a novel bactericidal non-fluorinated quinolone, formulated as a 1% cream, is anticipated during Q1 2016
BARCELONA, Spain I July 30, 2015 I Ferrer, a privately-held Spanish pharmaceutical company, today announces that it has successfully completed a second phase III clinical trial in adult and paediatric patients aged two months and older with impetigo, utilizing Ozenoxacin 1% cream as a topical treatment for dermatological infectious conditions.
The study demonstrated the superiority of Ozenoxacin 1% cream, applied topically twice daily for five days, versus placebo, on both the clinical and bacteriological endpoints by the end of therapy (day 6-7). In addition, Ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit two (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. It involved 412 adult and paediatric patients aged two months and older with a clinical diagnosis of bullous or non-bullous impetigo. The first regulatory filing is anticipated during Q1 2016 in Europe by Ferrer, in the United States by Medimetriks Pharmaceuticals, Inc. and in Canada by Cipher Pharmaceuticals Inc.
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and older with impetigo. In this trial Ozenoxacin demonstrated superiority to placebo on both clinical and bacteriological endpoints by the end of therapy (day 6–7) and a more rapid microbial clearance than placebo and retapamulin at visit two (day 3–4), ref: Future Microbiol (2014) 9(9), 1013 – 1023.
Ferrer obtained exclusive worldwide rights to Ozenoxacin (excluding China, Japan, Korea and Taiwan) from Toyama. Ozenoxacin 1% topical cream is the subject of a number of granted and pending patent applications. The product is available for licensing worldwide from Ferrer excluding China, Japan, Korea, Taiwan, the United States and Canada.
“Impetigo due to bacterial skin infections remains a common problem worldwide, especially in infants and young children living in warm, humid climates,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined global market value approaching €540 million ($600M) per annum.”
About Impetigo
Impetigo is a highly contagious bacterial skin infection. It most commonly affects 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 around 10% of the skin problems observed in paediatric clinics. It is the most common bacterial skin infection and third most common skin condition of children.
The condition usually manifests as blisters or sores on the face, neck, hands and trunk. Scratching may spread the lesions to other parts of the body. 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.
About Ozenoxacin
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 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 two 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 two months and older) have demonstrated that topically formulated Ozenoxacin is efficacious, safe and well tolerated, exhibiting no dermal absorption and showing 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 global market for topical antibacterial products is approximately €540 million ($600M) per annum.
About Ferrer
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
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands in the United States. The company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care. Medimetriks owns the exclusive rights to Ozenoxacin for the US market. www.medimetriks.com
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. Cipher has completed seven transactions in 2015, including the acquisition of Innocutis and its seven branded dermatology products, to build its US 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. Cipher has the exclusive rights to Ozenoxacin for the Canadian market. www.cipherpharma.com.
SOURCE: Ferrer
Post Views: 39
