To: William Partmann who wrote (797 ) 12/29/1999 8:37:00 AM From: William Partmann Read Replies (2) | Respond to of 10345
DUBLIN, Ireland, Dec. 29 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN - news; ``Elan') today announced that the company has submitted the New Drug Application (``NDA') for ziconotide, a potential innovative new therapy for the treatment of intractable pain. Ziconotide, a novel N-type neuronal calcium channel blocker, is being developed for the treatment of chronic intractable pain. In two pivotal studies, ziconotide showed a significant reduction in pain compared to placebo. The NDA submission contains analyses of clinical studies of over 1,000 patients treated with ziconotide. More than 700 patients received ziconotide for the treatment of intractable pain by the intrathecal route of administration. Patients included in the pain studies had either failed systemic opioid (morphine like) therapy, or had become intolerant of therapy due to side effects. Safety and efficacy was studied in these patients with intractable pain caused by a wide array of underlying conditions with some individuals being treated in excess of three years. The submission was comprised of over 750 volumes and 300,000 pages of text and was also provided in electronic form. ``This is a very significant step for our company,' said Donal Geaney, chairman and chief executive officer of Elan. ``Ziconotide represents a major opportunity for Elan as we develop our product range in the area of pain management. We believe that ziconotide, once approved, will make an important contribution in the treatment of pain in patients who have failed other therapeutic approaches.' Elan is a leading worldwide specialty pharmaceutical company headquartered in Ireland, with its principal research, development, manufacturing and marketing facilities located in Ireland, the United States and Israel. Elan shares trade on the New York, London and Dublin Stock Exchanges. The statements in this press release may include forward-looking statements that involve risks and uncertainties including the difficulty of predicting regulatory approvals, as well as the other risks and uncertainties detailed from time to time in periodic reports, including Elan's annual report of Form 20-F for the fiscal year ended December 31, 1998, as amended by Elan's Form 20-F/A1, both filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements. SOURCE: Elan Corporation, plc