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MAYNE PHARMA GROUP LIMITED — Capital/Financing Update 2008
Oct 6, 2008
65396_rns_2008-10-06_031f7dc0-f54c-4da2-9106-4ce0686a4a19.pdf
Capital/Financing Update
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HALCYGEN SUCCESSFULLY COMPLETES FIRST PIVOTAL TRIAL WITH SUBA-ITRACONAZOLE
SUBA[] -itraconazole ― Improved anti-fungal targeting $600m market
Tuesday 7 October 2008, Melbourne Australia : HalcyGen Pharmaceuticals Limited (ASX: HGN) has successfully completed the first of three pivotal pharmacokinetic* studies scheduled under its Investigational New Drug application (IND) recently approved by the FDA (announcement 17 June 2008). The study has demonstrated that SUBA[] -itraconazole in a “half-dose” format gives comparable pharmacokinetic levels to Sporanox, the current itraconazole market leader.
The registration strategy for SUBA[] -itraconazole is designed to compare HalcyGen’s SUBA[] -itraconazole and the market’s leading product Sporanox**. HalcyGen’s CEO, Dr Roger Aston said, “This is a very pleasing result from our first clinical trial, our SUBA[] -itraconazole shows promise as a half-dose alternative to the higher dose Sporanox. We expect to have all three pharmacokinetic studies completed by Christmas prior to seeking further guidance from the FDA”
HalcyGen has clinically evaluated SUBA[] -itraconazole, a patented formulation, in five successful pharmacokinetic studies in Australia. These studies have demonstrated that HalcyGen’s formulation has significantly improved bioavailability (absorption by the gastrointestinal track) compared with the market leader, enabling the use of a lower dose of the drug. HalcyGen’s formulation also provides for more stable blood levels compared to Sporanox.
The current global market for itraconazole is in excess of US$600 million per annum – HalcyGen’s SUBA[] -itraconazole is targeting this market.
*Pharmacokinetic Studies: Clinical pharmacokinetic studies are performed to examine the absorption, distribution, metabolism and excretion of a drug under investigation (investigational drug and approved drug) in healthy volunteers and/or patients. Pivotal pharmacokinetic studies are studies that form part of the registration dossier for a new drug application (NDA).
**Sporanox is the market leading form of itraconazole and is owned by Janssen Pharmaceutical Products LP – part of the Johnson & Johnson Group.
-ENDS-
Enquiries: Dr Roger Aston Craig Bottomley 0402 762 204 03 8614 7777
Rudi Michelson Monsoon Communications 0411 402 737
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 Hospira, Inc. The Company will initially develop and market two products in partnership with Hospira. Subject to performance and meeting certain other criteria, the Company has the opportunity to develop further products with Hospira.
Through the global exclusive license granted to HalcyGen by Hospira, Inc., for the commercialisation of SUBA™-Itraconazole, Hospira has a first right of refusal to manufacture SUBA™-Itraconazole to support sales. Hospira is a global specialty pharmaceutical and medication delivery company.