Irish biotech group Elan yesterday reported better than expected results for the first financial quarter and reiterated the company's bullish views for the return of its multiple sclerosis drug Tysabri.
Increased sales and tighter cost control saw net losses at the group fall 71 per cent to $33.3 million, with the loss per share coming in at eight cents compared to forecasts of 21 cents.
"This improved financial performance is largely due to a growth in revenues, the continued improvement in operating margins and the costs associated with the temporary suspension of Tysabri in February 2005," said chief financial officer Shane Cooke.
Elan also said it expected to launch the MS drug Tysabri in both the United State and Europe towards the beginning of the third quarter of this year.
Mr Cooke said Elan expected to be in a position to put Tysabri back on the shelves within weeks of approval by the US regulator, the Food and Drug Administration (FDA).
The FDA has until June 28th to decide on the drug's future. It has already extended its deadline by 90 days and cannot do so again.
Elan's head of research, Dr Lars Ekman, said the indications were that the FDA would follow the recommendation of an advisory committee and licence Tysabri for use by most patients.
Sales in Europe will commence in Germany within a couple of months of expected approval by the European authorities this summer.
Patients in 25 other European states will begin to access the drug over the course of the following 12 months.
Elan and its partner, Biogen Idec, expect to spend around $300 million annually on Tysabri and say they will break even when about 20,000 patients are on the therapy.
When the drug was suspended just months after its launch following the emergence of two cases of a potentially fatal brain disease in clinical trials, 2,000 patients were taking the drug with a further 7,000 waiting for supplies, according to Elan.
Mr Cooke said yesterday that there were 200,000 patients in the US receiving treatment for MS. A further 50,000 had abandoned treatment out of 450,000 MS sufferers overall.
In Europe, there were 150,000 patients undergoing treatment on other MS drugs with 50,000 having given up out of a total patient population of 500,000. Outside of Tysabri, Dr Ekman said there was "signal progress throughout our pipeline", most notably in the company's Alzheimer's Disease programme, which is being developed in conjunction with Wyeth.
The company reiterated its guidance for full-year losses before interest, tax, depreciation and amortisation of between $150 million and $175 million.
