FORMER junior biotech Pharmaxis took its biggest step towards becoming a fully-fledged pharmaceutical company yesterday, winning a Swedish licence for its asthma drug Aridol.
Shares in Pharmaxis surged 4 per cent or 11c to $2.78 after the announcement, with analysts predicting it would earn 80 per cent gross margins on Aridol amid projected global revenue of $250 million.
Discovered, developed, manufactured and marketed over 12 years in Australia without offshore backing or collaboration with a big pharmaceutical company, the drug is claimed to allow accurate asthma diagnosis for the first time.
Pharmaxis CEO Alan Robertson said yesterday the Swedish approval opened the door for Aridol to reach asthma patients worldwide.
"Over coming years we are optimistic Aridol will become the established yardstick by which asthma is assessed globally," Dr Robertson said.
Aridol is administered as a dry powder in a hand-held inhaler.
Wilson HTM analyst Graeme-David Wald said yesterday the strength of Pharmaxis lay in its status as the first Australian biotech to take a drug to market without backing from a pharmaceutical company.
"The important issue is that it did all of this without collaborating with any big pharmaceutical companies, so it owns the intellectual property 100 per cent," he said.
"(The Swedish approval) is the absolute transition of the company from a biotech company which relies solely on the development of its science to a fully-fledged pharmaceutical company that has products on a global basis for which it receives revenues on high gross margins," Dr Wald said.
"I estimate that gross margins for this product will be at least 80 per cent.
"This approval opens the door for European-wide approval into all EU countries. Within the next two weeks we will see the company publish the results of US clinical trials, Within the next two months they'll apply to the FDA. In the next 12 to 14 months the product is likely to be available in the US."
Pharmaxis is also on the verge of completing late-stage clinical trials for lung disease drug Bronchitol.
"There is no drug on the market to treat that disease, and it affects millions of people," Dr Wald said.
"Those are the events one will expect for the next six months to really shoot up the valuation of this company.
"They are bringing new products to the market for which there is a strong need."
Pharmaxis's clinical trial results suggested 25 per cent of asthma patients were being treated with incorrect dosages of medication, and up to 17 per cent could safely reduce the dose.
Pharmaxis will follow Swedish registration with an attempt to market Aridol in 27 European Union member states.