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| Elan Receives FDA Approval of AVINZA(TM) A Once-Daily Capsule for Chronic, Moderate-to-Severe Pain |
DUBLIN, Ireland, March 21 /PRNewswire-FirstCall/ -- The U.S. Food and Drug
Administration has granted marketing approval of Elan Corporation, plc's new
drug application for AVINZA (morphine sulfate extended-release) capsules for
the once-daily treatment of chronic, moderate-to-severe pain in patients who
require continuous, around-the-clock therapy for an extended period of time,
Elan announced today.
AVINZA (formerly Morphelan(TM)) was developed by Elan Corporation, plc
(NYSE: ELN) ("Elan"), which licensed the U.S. and Canadian marketing rights to
Ligand Pharmaceuticals Inc. (Nasdaq: LGND) in 1998. Elan retains marketing
rights for the rest of the world and regulatory filings are pending in major
territories. The product will be manufactured by Elan in the United States
and is expected to be launched in the second quarter of 2002.
"AVINZA represents a major technical achievement for Elan and a medical
advance in the management of chronic pain," said Donal J. Geaney, Chairman and
Chief Executive Officer of Elan. "Using our proprietary controlled release
technology (SODAS(R)), we have engineered a morphine capsule product, which
gives patients protection from moderate to severe pain over a 24-hour period.
In safety and effectiveness trials conducted by Elan, AVINZA, given once
daily, provided effective 24-hour pain relief. AVINZA will provide an
important therapeutic option for many patients who live with the pain
associated with cancer and other medical conditions."
AVINZA's novel dual release formulation contains immediate- and
sustained-release morphine beads. Once steady-state plasma levels of morphine
are achieved, the immediate-release beads enable AVINZA to provide rapid
exposure to morphine. The sustained-release beads enable morphine to be
absorbed by the body gradually, thus maintaining plasma morphine levels over a
24-hour dosing period.
Elan is a leading worldwide, fully integrated biopharmaceutical company
headquartered in Ireland, with its principal research, development,
manufacturing and marketing facilities located in Ireland and the United
States. Elan is focused on the marketing of therapeutic products and services
in neurology, pain management, infectious disease, dermatology, oncology and
the development and commercialisation of products using its extensive range of
proprietary drug delivery technologies. Elan shares trade on the New York,
London and Dublin Stock Exchanges.
This news release may contain certain forward-looking statements by Elan
that involve risks and uncertainties and reflect the company's judgment as of
the date of this release. Actual events or results may differ from the
company's expectations. For example, there can be no assurance that AVINZA
will be successfully marketed. AVINZA contains morphine sulfate, a Schedule
II controlled substance, subject to distribution controls due to its potential
for dependence, misuse and abuse. AVINZA's side effects in clinical trials
were dose-dependent, and similar to those typically seen with opioid therapy.
Additional information concerning risk factors affecting Elan's business can
be found in prior press releases as well as in the company's public periodic
filings with the Securities and Exchange Commission. Elan disclaims any
intent or obligation to update these forward-looking statements beyond the
date of this release. This caution is made under the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995.
SOURCE Elan Corporation, plc
back to topRelated links:
Company News On-Call:
CONTACT:
Investors, U.S., Jack Howarth,
+1-212-407-5740, or +1-800-252-3526, or Investors, Europe, Emer
Reynolds, +353-1-709-4000, or 00800-28352600, both of Elan; or
Bruce Hayes, E.V.P. Healthcare Communications of Edelman,
+1-212-642-7790, for Elan
