Shares in Elan surged ahead yesterday after the company said US regulators would "fast track" consideration of its Antegren drug for treating Multiple Sclerosis (MS).
The fast-track designation from the US Food and Drink Administration (FDA) is seen as a strong boost to Elan, which should now be in a position to launch Antegren on the market early next year.
Analysts have estimated the global market for the drug, which is part-owned by Elan and US pharmaceutical firm, Biogen, could be worth about $4 billion (€3.3 billion) by 2008.
Elan's shares jumped in Dublin, reaching a high of €21.50, up 10 per cent on Friday's close. They closed at €20.70, up 6.4 per cent. In New York, where Elan is mostly traded, shares closed 1.79 per cent stronger at $24.40.
Merrion Stockbrokers analyst, Mr Peter Frawley said success with Antegren could help to propel Elan's shares to levels around $30 over the next 12 months.
Mr Frawley said that even modest progress on Elan's research into treatments for Alzheimer's could furthermore bring a "step change" in the firm's valuation. This could, he believes, lift Elan's shares to levels higher than $50.
Elan's Alzheimer's programme is still however at an early stage.
The "priority review" status that the FDA has granted to Antegren for MS tends generally to be available only to products that have the potential to be better than existing drugs used to treat an "unmet medical need".
The extent of the "unmet medical need" in the MS area is also behind the FDA's willingness to consider Antegren on the basis of one-year trial data for the drug. The regulator would normally insist on longer trials before it would consider approving a drug.
MS affects about one million people around the world, with many of these patients unable to gain relief from treatments currently on the market.
Meanwhile, the company said last night it had it has submitted an amendment to its New Drug Application (NDA) to the (FDA for approval of Prialt (ziconotide) for the treatment of severe chronic pain. The company anticipates a review time of approximately six months.
This amendment to the original NDA incorporates results from the most recent Phase III trial, which demonstrated a statistically significant result with Prialt, at lower doses. "We are encouraged about the new findings, which complement the data from the previously disclosed trials," said Lars Ekman, executive vice president, and president Research and Development, Elan.
