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Name | Symbol | Market | Type |
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Rolls-r 24 | LSE:43AI | London | Medium Term Loan |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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0.00 | 0.00% | 99.147 | 0 | 01:00:00 |
RNS No 3630m ELAN CORPORATION PLC 25th September 1997 ELAN CORPORATION, PLC ANNOUNCES PUBLICATION OF ITS PHASE II CLINICAL DATA FOR NEUROBLOC IN PATIENTS WITH CERVICAL DYSTONIA DUBLIN, IRELAND, September 25, 1997 - Elan Corporation, plc ("Elan") (NYSE: ELN) announced today that the results of its multi-center, double-blind, placebo-controlled Phase II safety, tolerability, dose-selection and efficacy study of Neurobloc (Botulinum toxin Type B, formerly known as "BotB") in patients with cervical dystonia (frequently referred to as spasmodic torticollis) appear in the September 1997 issue of the journal Neurology. Cervical dystonia is a severe condition of abnormal muscle tone and movement that can result in severe, painful abnormalities of posture or inability to flex and relax affected neck and shoulder muscles. Results from this study, involving 122 patients with cervical dystonia, revealed statistically significant clinical improvement in patients treated with a single injection of Neurobloc, as compared to the placebo-treated patients at all dose levels. This was especially significant for the highest dose group. At week 4 in the high dose group, the proportion of patients who responded was 77%. In an intent-to-treat responders analysis, the high dose group demonstrated a duration of effect that was statistically significant at week 12. No unexpected, clinically significant or serious drug-related adverse events were reported at any of the doses tested. "We are very encouraged by the Phase II results. This study, in conjunction with earlier studies, allowed us to confidently move forward into our Phase III program which is well underway in the United States and Canada" said Dr. Jan Wallace, vice president, clinical and regulatory affairs of Athena Neurosciences, Inc., a wholly-owned subsidiary of Elan. Dr. Wallace continued, "These are the first published results that have objectively shown in a multi-center, randomized, double-blind, placebo-controlled, parallel group study design that a botulinum toxin appears to be safe and effective in the treatment of patients with cervical dystonia". Mr. Donal Geany, Elans chairman and chief executive officer, added, "We are moving forward rapidly with the completion of our botulinum toxin dedicated manufacturing site". After completing the ongoing Phase III Neurobloc studies, if successful, Elan plans to submit its application to the U.S. Food and Drug Administration in 1998. Elan Corporation, plc is a leading worldwide drug delivery and biopharmaceutical company with its principal research and manufacturing facilities in Ireland, the United States and Israel. Elans 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 success and timing of regulatory approvals, the degree of market acceptance and pricing, the impact of competitive products, as well as the other risks and uncertainties detailed from time to time in periodic reports, including Elans annual report on Form 20-F for the year ended December 31, 1996, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements. Contact: Mary Bingham Director, Investor Relations Elan Corporation, plc Tel: 212 755 3218 END MSCLEFFLDKKLBKQ
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