FDA Approves Elan's Migraine Drug Frova(TM) (frovatriptan succinate)

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FDA Approves Elan's Migraine Drug Frova(TM) (frovatriptan succinate)
    DUBLIN, Ireland, Nov. 9 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN)
("Elan") announced today that the U.S. Food and Drug Administration approved
Frova(TM) (frovatriptan succinate) 2.5 mg tablets, for the acute treatment of
migraine attacks with or without aura in adults.
    Donal J. Geaney, chairman and chief executive officer of Elan commented,
"The FDA's approval of Frova is a key milestone in advancing our pipeline of
important products for patients with neurological disorders. We are excited to
bring to patients who suffer from migraine headaches, Frova, a new medicine
for migraine.  We are in discussions with potential co-promotion partners and
expect to conclude our launch plan this quarter."
    Approximately 10% of the U.S. population suffer from migraine attacks.  Of
these 27 million sufferers, over 50% remain under-diagnosed or under-treated.
The U.S. market in 2001 for migraine therapy is expected to be approximately
$1.4 billion for the overall triptan class with the oral triptans representing
$1.2 billion.
    The efficacy and tolerability of Frova was demonstrated in five
randomized, double blind, placebo-controlled trials.  According to Arthur
Elkind, MD, Director of the Elkind Headache Center, Mt. Vernon, New York, "My
experience with frovatriptan in a long-term, open label trial indicates it is
an effective treatment and provides a high degree of patient satisfaction."
    In a market in which only 29% of patients report they are very satisfied
with their migraine therapy, the benefits of Frova make it an important
alternative therapy in the treatment of migraine for many patients.  Migraine
attacks typically last four to seventy-two hours.  Frova 2.5 mg tablets have a
26-hour half-life.  Frova may represent an important advancement in the
treatment of migraine headache as no other currently marketed triptan has a
half-life of more than six hours.  Stephen Silberstein, MD, Director,
Jefferson Headache Center, Philadelphia, PA said, "The addition of
frovatriptan, with its long half-life, gives physicians another alternative to
managing patients."
    Frova is a 5-HT receptor agonist that binds with a high affinity for the
5HT(1B) and 5HT(1D) receptors and is believed to act on extracerebral,
intracranial arteries and to inhibit excessive dilation of these vessels in
migraine.  Frova was well-tolerated in clinical trials.  The side effects that
occurred most frequently following administration of Frova 2.5 mg tablets (in
at least 2% of patients, and at an incidence of greater than or equal to 1%
compared to placebo) were dizziness, paresthesia, headache, dry mouth,
fatigue, flushing, hot or cold sensation and chest pain.
    Elan licensed exclusive North American sales and distribution rights for
Frova in October 1998 from Vernalis Group, plc (LSE: VER).
    Elan Corporation, plc is a leading worldwide, fully integrated
pharmaceutical company headquartered in Ireland, with its principal research,
development, manufacturing and marketing facilities located in Ireland, the
United States and the United Kingdom.  Elan is focused on the discovery,
development, and marketing of therapeutic products and services in neurology,
pain management, oncology, infectious disease and dermatology and on the
development and commercialization of products using its extensive range of
proprietary drug delivery technologies.  Elan shares trade on the New York,
London and Dublin Stock Exchanges.

    This communication includes certain "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995.  These
statements are based on management's current expectations but actual results
may vary materially due to various factors.  The forward-looking statements in
this communication include statements about future operating results.  Certain
factors, including Elan's inability to successfully launch and market Frova
and other economic, competitive, business and/or regulatory factors affecting
Elan's business generally, could cause actual results to differ materially
from those described herein.  More detailed information about these factors is
set forth in Elan's filings with the Securities and Exchange Commission,
including Elan's Annual Report on Form 20-F for the fiscal year ended December
31, 2000.  Elan is under no obligation to (and expressly disclaims any
obligation to) update or alter these forward-looking statements, whether as a
result of new information, future events or otherwise.
SOURCE Elan Corporation, plc
http://www.elan.ie
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CONTACT:
Investors - U.S.- Jack Howarth,
+1-212-407-5740, or +1-800-252-3526, Europe - Emer Reynolds,
+353-1-709-4000, 00800-28352600, or Media - Max Gershenoff,
+1-212-407-5740, or +1-800-252-3526, all for Elan Corporation,
plc