Shares in Elan Corporation rose by almost 15 per cent on the New York Stock Exchange yesterday after the company said the new application for its ziconotide pain-killing drug had been accepted as filed by the US Food and Drug Administration (FDA).
The FDA has also agreed to a "fast-track" six-month review of the application for the drug, which is being developed for the treatment of severe chronic pain in diabetes, cancer and AIDS patients.
Under US law, the FDA has 60 days from submission of an application to determine whether or not it is filed or whether to send it back. It can also decide to give a drug a priority review, lasting six months rather than a year.
Its decision to grant the shorter review period for ziconotide means that, if it approves the drug, the company could have it on the market around the end of the third or the start of the fourth quarter.
According to NCB Stockbrokers, a third-quarter launch of the drug could add up to nine cents to Elan's earnings per share this year.
The company believes the drug has a potential market of about one million patients in the US, while analysts have predicted revenues in the $300$500 million (€311E519 million) range once peak sales are reached.
The ziconotide application was originally due for submission last April but was delayed until December, causing a slide in Elan's share price.
Yesterday's announcement, which puts the approval application back on track, boosted the shares by $5.25 to $40.87 1/2 on Wall Street, while in Dublin Elan shares closed 4.6 per cent higher at €39.
Ziconotide was discovered by Neurex, a US firm which Elan purchased for $700 million in 1998.