Skip to Content

New potential application for SUBA-Itraconazole in oncology

Improved anti-fungal drug targets oncology market

MELBOURNE Australia,11 June 2008 - HalcyGen Pharmaceuticals Limited (ASX: HGN) can confirm that itraconazole, the active ingredient in HalcyGen's lead drug SUBA-Itraconazoleä, is a potent inhibitor of the proliferation of endothelial cells. These are the key cells involved in tumour-angiogenesis and related growth of tumours.

This finding emerged from the collaborative research agreement with the University of Otago, New Zealand (announced 16 January 2008) to investigate the anti-tumour activities of the Company's lead product SUBA-Itraconazoleä.

Research at the Johns Hopkins School of Medicine published last year in the American Chemical Society's Chemical Biology*, demonstrated that itraconazole has the ability to inhibit the growth of tumour vasculature (anti-angiogenesis). The physiological process of angiogenesis is important in the body for wound healing and tissue growth, however, it is also important in the transition to malignancy and growth of tumours. Tumours can induce new blood vessels (angiogenesis) to provide nutrients and oxygen essential for tumour growth. Researchers and companies have been searching for many years to find a potent drug that can inhibit or prevent tumour-related angiogenesis as a potential treatment for cancer. Genentech's AvastinÒ, the first anti-angiogenesis drug, is used to treat colorectal cancer. Anti-angiogenesis drugs target a multi-billion dollar market.

The successful completion of the initial work at Otago paves the way to evaluating the ability and benefits of SUBA-Itraconazoleä in inhibiting tumour growth following oral administration.

HalcyGen's SUBA-Itraconazoleäformulation was licensed from Hospira Inc. to treat fungal infections. Under the terms of the license agreement, HalcyGen may pursue and commercialise other clinical applications of SUBA-Itraconazoleä.

SUBA-Itraconazoleä is a proprietary formulation of itraconazole that has been clinically evaluated by HalcyGen in five pharmacokinetic** clinical studies. These studies have demonstrated that HalcyGen's formulation has significantly improved bioavailability (absorption by the gastrointestinal track) compared with the market leader Sporanoxâ***, hence providing the opportunity for launching a lower dose form of the drug. HalcyGen is currently preparing for a program of pivotal registration trials to register SUBA-Itraconazoleä as an anti-fungal agent.

The current global market for itraconazole for the treatment of fungal infections is in excess of US $600 million per annum. HalcyGen's SUBA-Itraconazoleä is targeting this market. The oncology application could substantially enlarge the market potential.

*Curtis R. Chong, Jing Xu, Jun Lu, Shridhar Bhat, David J. Sullivan, Jr., and Jun O. Liu, Vol . 2, No. 4 - American Chemical Society, Chemical Biology

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



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(tm)-Itraconazole, Hospira has a first right of refusal to manufacture SUBA(tm)-Itraconazole to support sales. Hospira is a global specialty pharmaceutical and medication delivery company.

Monsoon Communications Level 1 350 Collins Street Melbourne VIC 3000 Ph: 03 9620 3333

Posted: June 2008