FDA Provides Guidance And Regulatory Framework For HalcyGen's Phase III Registration Study Of Subazole

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 29 Nov 2007 - 2:00 PDT

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HalcyGen Pharmaceuticals Limited (ASX: HGN) is pleased to announce that it has met with the US FDA as regards the regulatory framework and strategy for its pivotal Phase III study.

The FDA have responded positively to the proposed development by HalcyGen of a "half-dose" form of itraconazole and have requested that the company undertake a Phase III study geared towards demonstrating the safety/improved safety of HalcyGen's formulation in comparison to the leading itraconazole brand, Sporanox*.

HalcyGen's CEO, Dr Roger Aston said, "The Company is excited about following the FDA's clinical requirements for the forthcoming Phase III trial - safer is clearly better and would give us a substantial commercial advantage over Sporanox. If our half-dose form translated into a product that offered improved safety benefits to patients we should achieve significant market penetration. The potential safety benefits that could be derived with a half-dose formulation would enhance our position in discussions with marketing partners.

HalcyGen's Subazole formulation was licensed from Mayne Pharma International (Mayne) (a wholly owned subsidiary of Hospira Inc.). Subazole, a proprietary formulation, has been clinically evaluated by HalcyGen in five phase II pharmacokinetic studies, which are designed to measure blood levels of Subazole in comparison to Sporanox. These studies have demonstrated that HalcyGen's formulation has significantly improved bioavailability (absorption by the gastrointestinal track) compared with the market leader, hence providing the opportunity for launching a lower dose form of the drug.

HalcyGen's initial strategy was to demonstrate bioequivalence (identical active blood levels of the drug) and non-inferiority to Sporanox in pharmacokinetic analysis trials in Australia, however, following the meeting with the FDA, HalcyGen will now undertake a Phase III clinical registration study to determine whether its "half-dose" formulation is as safe or safer than Sporanox in the USA. The FDA has furthermore requested that HalcyGen, undertake its Phase III study in "onychomycosis", fungal infection of the toe nail. This study could expand the market size for Subazole if improved safety is demonstrated.

The FDA has requested that HalcyGen arrange for the review of the proposed Subazole product dossier by the Dermatology division of the FDA prior to starting its phase III study. This division of FDA generally reviews products for onychomycosis and dermatologists are key prescribers for this indication.

HalcyGen is now building on its five successful pharmacokinetic studies undertaken in Australia and has a clear and attainable goal for Subazole following the meeting with FDA.

The current global market for Itraconazole (Sporanox) is in excess of US $600 million dollars - HalcyGen's Subazole is targeting this market.

*Subazole is the registered trademark owed by HalcyGen Pharmaceuticals Limited. Previously Subazole was referred to as SUBA-Itraconazole, a Trade Mark owned by Mayne Pharma International.

*Sporanox is owned by Janssen Pharmaceutical Products LP-part of the Johnson & Johnson Group.

Background on HalcyGen

HalcyGen has been founded to bridge the gap between mainline pharmaceutical companies and high volume generics companies through the development and licensing of new improved proprietary generic formulations known as "Super Generics" or "High Functionality Generics". HalcyGen's strategy is to capitalise on the value associated with the development and commercialisation of novel, improved variants of existing proprietary pharmaceuticals known as Super Generics.

The basis of the HalcyGen's strategy is a strategic licensing partnership with global pharmaceutical company Mayne Pharma International. The Company will initially develop and market two products in partnership with Mayne Pharma International in anti-infectives. Subject to performance and meeting certain other criteria, the Company has the opportunity to develop further products with Mayne Pharma International.

HalcyGen Pharmaceuticals Limited