Elan Corporation PLC - Re Neurobloc Phase II Study
29 9월 1997 - 11:54PM
UK Regulatory
RNS No 5057x
ELAN CORPORATION PLC
29th September 1997
The following was announced by Axogen Limited ("Axogen"), the outstanding
common shares of which are subject to a purchase option by Elan Corporation
plc ("Elan"), which option expires on December 31, 2001.
AXOGEN LIMITED ANNOUNCES PUBLICATION OF NEUROBLOC PHASE II STUDY
BERMUDA, September 29, 1997 - Axogen (AMEX: AXG/U) announced today that the
September issue of the journal, Neurology, had published the results of Elan
(NYSE: ELN) 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). Axogen, which has an
option to acquire a license to certain United States rights to Neurobloc, is
currently funding the ongoing Phase III clinical program for Neurobloc.
Cervical dystonia is a severe condition of abnormal muscle tone and movement
than can result in severe, painful abnormalities of posture or inability to
flex and relax affected neck and shoulder muscles. Elan reported that results
from its 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.
Mr Kevin Insley, Vice President and Chief Financial Officer of Axogen,
commented, "we are pleased to note the encouraging Phase II results from the
Elan study and look forward to completion of the ongoing Phase III program
funded by Axogen. It is also pleasing to observe Elans commitment to this
product as demonstrated by the construction of a dedicated botulinum toxin
manufacturing site". Upon completion of the Phase III Neurobloc studies, if
successful, Elan plans to submit its application to the US Food and Drug
Administration ("FDA") in 1998. Axogens option to acquire a license to
certain US rights to Neurobloc is triggered in the event of approval of the
product by the FDA.
Axogen Limited, a Bermuda corporation, develops therapeutic products for
persons with neurological disorders. The company was funded through a public
offering of units in November 1996; the units trade on the American Stock
Exchange. The outstanding common shares of Axogen are subject to a purchase
option held by Elan, which expires on December 31, 2001.
The statements in this press release that are not historical facts, including
statements about the potential outcome or the clinical development program and
any expectation of regulatory approval of Neurobloc, are forward looking
statements, subject to uncertainty. For additional information regarding
risks applicable to Axogen, see Axogens Registration Statement on Form F1
dated November 19, 1996, filed with the Securities and Exchange Commission.
Contact:
Kevin Insley
Vice President and Chief Financial Officer
Axogen Limited
Ph: 441 292 9169
END
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