MAYNE PHARMA GROUP LIMITED — Capital/Financing Update 2008

Jun 16, 2008

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FDA ALLOWS HALCYGEN’S IND APPLICATION – PIVOTAL USBASED CLINICAL TRIALS TO PROCEED

SUBA ™ -Itraconazole is an improved anti-fungal targeting $600m pa market

17 June 2008, Melbourne Australia : HalcyGen Pharmaceuticals Limited (ASX:HGN) has received approval from the US Food and Drug Administration (FDA) to begin pivotal pharmacokinetic* (PK) studies in the United States. These studies are the precursor to SUBA™-Itraconazole product registration.

The allowance to proceed comes 30 days after HalcyGen submitted its Investigational New Drug (IND) application (announced 14 May 2008). The approval is a major milestone in the registration strategy for SUBA™-Itraconazole which will examine the bioequivalence of HalcyGen’s SUBA-Itraconazole™ and the market-leading product Sporanox®**.

HalcyGen CEO Dr Roger Aston said, “Initiation of pivotal studies in the US is one of HalcyGen’s biggest milestones. Registration of our product in the US after the pivotal studies will enable product sales in the US and in many other countries without further clinical trials.”

“Recruitment for the first PK study is underway.”

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 (PK): 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.