Smelly feet lift biotech Olga Galacho Biotechnology ALMOST a year to the day since it listed, HalcyGen Pharmaceuticals looks ready to gain a toe-hold in the $600 million market for fungal foot infection drugs. News the company had received a regulatory nod from the US Food and Drug Administration (FDA) also propelled the shares to a unique position for a biotech stock in the battered sector. Shares in the anti-fungal drug developer jumped by a third on the announcement that its trademarked compound, Subazole, had moved into its final testing phase ahead of registration. The company expects to present test results to the FDA before the end of the year. Known as a supergeneric because it is an improved version of an existing drug, it is a type of medication the FDA particularly likes, as its efficacy is already proven. Supergenerics such as Subazole, however, are often administered in lower doses than established drugs, leading to fewer side-effects. The drug, bought from Mayne Pharma International in its preclinical test stage, targets fungal infections generally, but particularly of toenails. The global market is estimated to be worth more than $600 million and is dominated by Johnson & Johnson's Sporanox. Melbourne-based HalcyGen has a Step up: better anti-fungal drug. strategic licensing deal with Mayne's new owner, global pharmaceutical Hospira, that allows it to acquire, develop and test compounds from Mayne's portfolio. Once regulatory obligations are met, Hospira is given first right to market the drugs. Recruitment for the final-stage testing of Subazole, known as pivotal studies, has begun in the US. HalcyGen, which has pokies king Bruce Mathieson on its board, has already put Subazole through its paces in Australia. Clinical studies in Australia have shown Subazole to be more readily absorbed than the market leader, according to HalcyGen chief executive Roger Aston. "Initiation of pivotal studies in the US is one of HalcyGen's biggest milestones," Dr Aston said. "We expect to meet the FDA again before the end of the year," he said. HalcyGen shares closed 100 higher at 400. Ref: 37752299 Copyright Agency Limited (CAL) licenced copy Herald Sun (Melbourne) Wednesday 18/06/2008 Page: 28 Section: Business News
HGN Price at posting:
0.0¢ Sentiment: LT Buy Disclosure: Held
