Elan Corporation PLC - Re Phase II Clinical Data
September 25 1997 - 8:40AM
UK Regulatory
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
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