Mayne Pharma chief executive Scott Richards said SUBA-itraconazole would reduce the need for invasive procedures.
«We have good data on skin cancer patients that shows our product works and is safe,» Mr Richards said.
«Now, what we have to do is a confirmatory study in a bigger patient population to make sure this product really works and meets the criteria. We’re three years away from being on the market, but we’ve got a high degree of confidence.»
The trial is in its third phase, with researchers from Canada and Europe testing the effectiveness of SUBA-itraconazole to treat ovarian, bowel and prostate cancers.
University of New South Wales dermatologist Dr Deshan Sebaratnam said the trial’s proposal was «biologically plausible» but more clinical trials would be needed to deterimine its efficacy.
«Itraconazole is widely known as an antifungal but it also has other effects,» Mr Sebaratnam said.
Itraconazole is widely known as an antifungal but it also has other effects,
Dermatologist Deshan Sebaratnam
«It is known to modulate signalling pathways which are important for some cancers such as basal cell carcinoma (the most common type of any cancer in Australia).»
TOLSURA, a SUBA-itraconazole product used to treat fungal infections, was approved by the US Food and Drug Administration in the first half of the 2018-19 financial year, making it Mayne Pharma’s first drug to be FDA-approved since its listing on the Australian Stock Exchange in 2007.
Mayne Pharma’s half-year reported a $US2.6 million net profit for the first half of the financial year turning around a $US174 million loss the year before.
Mayne Pharma’s revenue increased by 13 per cent to $US274 million, while earnings before interest, tax, interest, depreciation and amortisation (EBITDA) jumped 184 per cent to $US65 million.
But the results disappointed investors who wiped 5 per cent off the company’s share price which closed at 76 cents.
Bell Potter senior analyst John Hester said while the EBITDA was slightly below expectations, the revenue was in line with his estimates.
«The underlying profit was modestly below our expectations,» Mr Hester said. «There were a number of one-off charges, also the tax rate was higher than the market was expecting and that meant the net profit after tax was probably underwhelming.»
Mr Hester said the company’s clinical trials would be «very relevant» in the longer term and that he was «overall reasonably pleased» with the company’s results.
We’ve got a high degree of confidence.
Mayne Pharma is facing increasing pressure in its generic pharmaceuticals business, Mr Richards told investors on Friday, with sales down three per cent to $AU176 million.
Dofetilide, an anti-arrhymatic medication used to prevent irregular heartbeats such as atrial fibrillation and atrial flutter, revenue plunged by 73 per cent to $US9 million.
«Dofetilide was impacted by a new competition with sales down 70 per cent, driven by market share loss, pricing pressure and shelf stock adjustments,» Mr Richards said.
«Excluding dofetilide, GPD [generic products distribution] sales and gross profit were up 10 per cent and 112 per cent respectively in US dollar terms.»
The performance of the generic products division will vary depending on the timing of its new product launches, competitor launches or withdrawals on key products and portfolio optimisation, he added.
Sumeyya is a reporter for The Age.