Shares in Elan strengthened in New York yesterday as investors digested news that trial data on its flagship drug, Antegren, would not be released as early as some had expected.
Elan, which owns Antegren with US pharmaceutical firm Biogen, said on Tuesday night that data from one-year trials on Antegren for the treatment of multiple sclerosis (MS) would not be released until the drug had been approved by US regulators.
This approval is not expected to come until the end of November, which would be six months after Elan filed its application with the Food and Drug Administration (FDA).
Both Elan and Biogen had previously indicated that the data might be made public in time for a major European MS conference at the start of October.
Analysts said that while the delay was disappointing, it was probably not fundamental to Elan's plans for commercialising Antegren over the coming year.
Elan said it was holding the data back to "protect the integrity" of two-year MS trials that were still ongoing. Data from the two-year trials are expected to be available in mid-2005.
Mr Robert Brisbourne of Merrion Stockbrokers said he took comfort from Elan's decision to file Antegren for review by Canadian authorities on the basis of existing one-year data.
Further submissions to regulatory authorities in Australia and Switzerland are expected before year-end. This move to progress with filings underlined the company's confidence in the one-year results, Mr Brisbourne said.
Elan has already made applications on Antegren to authorities in the EU, as well as to the FDA.
The firm is also working with Biogen on developing Antegren for the treatment of rheumatoid arthritis and Crohn's disease.
Analysts have estimated the global market for the drug could be worth about $4 billion (€3.23 billion) by 2008 in the treatment of MS alone.
Elan is expected to file an application for treatment of Crohn's with US regulators soon. The firm began an advanced trial for rheumatoid arthritis over the second quarter of the year.
Shares in Elan opened low in the US yesterday but were up by 6.76 per cent at $21.96 on good volume at their closing. The stock shed 10 cents to close at €17.31 on the ISEQ.
