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Ferrer Submits IND for Arasertaconazole Nitrate, a Safe, Fast-Acting Topical Antifungal in Development for Vulvovaginal Candidiasis


8/8/2012 10:48:09 AM

Barcelona, Spain, August 8, 2012 - Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to commercialisation, announces today that it has filed an IND for its topical antifungal agent Arasertaconazole nitrate.

The agent has recently demonstrated rapid symptomatic relief and significant clinical and mycological benefits after a single administration delivered as a vaginal suppository (pessary) formulation in a multicentre Phase II study in patients with VulvoVaginal Candidiasis (VVC). VVC, or vaginal thrush as it is also known, is a common infection affecting 70 - 75 per cent of women at least once in their lives. The worldwide market for gynaecological antifungal products exceeds USD 600 million per annum.

Arasertaconazole is a new, fast-acting topical antifungal. The agent has a broad spectrum of activity against Candida spp involved in VVC, including species described as resistant to fluconazole. It is the active, patented, R-enantiomer of sertaconazole nitrate, itself an antifungal agent developed by Ferrer and marketed for more than 20 years in more than 70 countries. Formulated as a vaginal suppository (pessary), Arasertaconazole has demonstrated very low systemic exposure, a good safety profile and was well tolerated in clinical studies involving 283 female subjects to date.

In the multicentre Phase II dose-ranging study involving 229 female patients with VVC, Arasertaconazole formulated as a vaginal suppository (pessary) demonstrated both fast-acting (superiority to placebo at 8 plus/minus 2 days of treatment) and prolonged (up to at least 26 plus/minus 4 days) clinical and mycological efficacy at all doses tested (150mg, 300mg, 600mg). The therapeutic response to Arasertaconazole was dose-dependent, with the 600mg dose most efficacious. Moreover, Arasertaconazole showed evidence of rapid relief from additional clinical symptoms (at less than 2 days, e.g. irritation and itching) when compared to placebo. Arasertaconazole was both safe and well tolerated in this study.

"VulvoVaginal Candidiasis (VVC) due to Candida spp infections remains a common problem worldwide, especially in women of childbearing age. The emergence of both treatment resistant Candida species and new pathogenic strains are considered some of the reasons for the underserved medical needs in this condition," said Antonio Guglietta, R&D Director at Ferrer. "Following discussions with the regulators, Ferrer will initiate Phase III clinical studies that will further differentiate Arasertaconazole as a safer, fast-acting antifungal treatment for VVC in women aged more than 12 years old."

Ferrer is currently assessing alternative formulations for Arasertaconazole as treatments for other topical fungal infections that include tinea pedis (athlete's foot).

Arasertaconazole, as well as the vaginal suppository (pessary) formulation, is the subject of granted and pending patent applications and is available for further development and commercialisation worldwide from Ferrer.

About VulvoVaginal Candidiasis (VVC)

Despite currently available medications, VulvoVaginal Candidiasis (VVC) remains a common problem worldwide affecting all strata of society. The infection, caused by Candida spp, affects 70-75 per cent of women at least once during their lives, most frequently in young women of childbearing age. The emergence of treatment resistant Candida species, appearance of new pathogenic strains, and poor understanding of anti-Candida host defence mechanisms are considered the main reasons for the underserved medical needs in this condition.

Successful treatment of VVC is dependent on compliance with therapy; thus, single-dose regimens offer the most effective treatment option for most patients with vaginal candidiasis. In addition, the use of topical agents avoids the potential systemic adverse effects and drug interactions that have been noted with oral antifungals.

About Arasertaconazole nitrate

Arasertaconazole nitrate is a safe, fast-acting topical antifungal which has shown a wide spectrum of activity against yeasts, dermatophytes and moulds. It is the active, patented, R-enantiomer of sertaconazole nitrate, an antifungal developed by Ferrer and marketed for more than 20 years in more than 70 countries.

Arasertaconazole has a broad spectrum of activity against Candida spp involved in VVC, including species described as resistant to fluconazole. In addition, Arasertaconazole is active against the common bacteria involved in vaginal infections and also possesses 'best-in-class' anti-inflammatory activity, both at concentrations that are attained following topical administration. These additional activities may contribute to the profile of rapid symptomatic relief and fast-acting clinical benefits observed with Arasertaconazole, in addition to fungus eradication.

Arasertaconazole demonstrated both clinical and mycological efficacy (superiority to placebo at 8 plus/minus 2 days of treatment) at all doses tested in a Phase 2 dose-ranging study involving 229 female patients with VVC (150mg, 300mg, 600mg). The therapeutic response to Arasertaconazole was dose-dependent, with the 600mg dose most efficacious. In addition, Arasertaconazole showed evidence of fast acting antifungal effects (at less than 8 days) and rapid relief from additional clinical symptoms (at less than 2 days, e.g. irritation, itching). Arasertaconazole has demonstrated very low systemic exposure, a good safety profile and was well tolerated in clinical studies involving 283 female subjects to date.

Arasertaconazole as well as the vaginal suppository (pessary) formulation, is the subject of a number of granted/pending patent applications and is available for further development and commercialisation worldwide from Ferrer.

About Ferrer www.ferrergrupo.com

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


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