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| Elan and UCB Announce Agreement to Co-Promote New Migraine Drug FROVA (TM) |
Product to Be Launched Q'2 2002
DUBLIN, Ireland and SMYRNA, Ga., March 28 /PRNewswire-FirstCall/ --
Elan Corporation, plc (NYSE: ELN) ("Elan") and UCB Pharma, Inc., the US
affiliate of a Belgium R&D-based international pharmaceutical and chemical
group ("UCB"), announced today that they have entered into an agreement to
co-promote the new migraine drug FROVA (frovatriptan succinate) in the
United States. Elan and UCB will launch FROVA in the second quarter of 2002.
Under the terms of the co-promotion agreement, UCB will co-promote FROVA
with Elan to neurologists using their combined sales forces of 265 field
personnel. UCB will also promote FROVA with its primary care sales force of
approximately 475 field representatives. The co-promotion between the
companies covers a seven-year period. The financial terms of the transaction
were not disclosed. Both companies are obligated to provide defined selling
and promotional support for the product, and will jointly develop marketing
strategies for FROVA.
The U.S. Food and Drug Administration approved FROVA 2.5 mg tablets in
November 2001 for the acute treatment of migraine attacks with or without aura
in adults. Migraine attacks typically last 4 to 72 hours. One of FROVA's
unique features is that it has a half-life of 26 hours. No other currently
marketed triptan has a half-life of more than 6 hours.
Approximately 10 percent of the U.S. population experience migraine
attacks. Of this 27 million population, more than 50 percent remain
under-diagnosed or under-treated. The overall triptan class accounted for
approximately $1.4 billion in U.S. sales in 2001, with 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."
"I am very pleased to have UCB as our partner in bringing FROVA to the
U.S. market," said Elan's Chairman and Chief Executive Officer Donal J.
Geaney. "Elan's criteria for a committed co-promotion partner required an
organization that had a track record in successfully executing co-promotion
arrangements. UCB's co-promotion programs for Ditropan XL(R) and Zyrtec(R)
provide the background for an enduring relationship with Elan for FROVA. We
look forward to the successful market introduction of FROVA."
"We are delighted to be partnering with a leading company like Elan to
launch this important new treatment for migraine," said Tony Tebbutt,
President of UCB Pharma, Inc. "UCB's co-promotion programs with Pfizer on
Zyrtec(R) and with ALZA on Ditropan XL(R) have contributed significantly to
the growth for those two products. We are confident that the unique
attributes of FROVA and our dedicated selling effort will result in the
successful launch of the drug in the U.S."
FROVA is a 5-HT receptor agonist that binds with a high affinity for the
5HT1B and 5HT1D 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 were
dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold
sensation and chest pain. For additional information, consult full
prescribing information.
Elan Corporation, plc 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, oncology,
infectious disease, 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.
UCB Pharma, Inc., with U.S. headquarters in Smyrna, Georgia, is the
North American subsidiary of the global research-based pharmaceutical sector
of UCB S.A. This Pharmaceutical sector is dedicated to the development and
commercialization of innovative pharmaceutical products for the treatment of
neurological diseases and allergy-asthma. UCB S.A. has core businesses in
pharmaceuticals, chemicals and films, and employs approximately 10,000 people
globally and operates in more than 100 countries. Worldwide headquarters are
located in Brussels, Belgium. UCB shares are quoted on the Euronext (merged
Stock Exchange of France, The Netherlands and Belgium).
This news release may contain certain forward-looking statements by the
companies that involve risks and uncertainties and reflect the companies'
judgment as of the date of this release. Actual events or results may differ
from the companies' expectations. For example, there can be no assurance that
FROVA will be successfully launched, or that FROVA will be successfully
differentiated from other marketed triptans. Additional information
concerning risk factors affecting the companies business can be found in prior
press releases as well as in each companies public periodic filings with the
Securities and Exchange Commission. Both Elan and UCB disclaim 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.
Zyrtec(R) is a registered trademark of Pfizer, Inc. in the United States.
Ditropan XL(R) is a registered trademark of ALZA Corporation in the
United States.
SOURCE Elan Corporation
back to topRelated links:
Company News On-Call:
CONTACT:
Investors, Jack Howarth, +1-212-407-5740, or
+1-800-252-3526, or jack.howarth@elan.com, or Emer Reynolds,
+353-1-709-4080, or 00800-2835-2600, or emer.reynolds@elan.com,
or Media, Erin Porta, +1-212-299-8971, all of Elan Corporation;
or Lisa Garman of UCB Pharma, +1-770-437-5569, or
lisa.garman@ucb-group.com
