FDA Approves New Dosage Strengths of Elan's Zonegran; Providing Flexible Dosing Options For Improved Management of Patients
29 August 2003 - 4:07PM
UK Regulatory
BW20030829002018 20030829T130724Z UTC
( BW)(ELAN)(ELA) FDA Approves New Dosage Strengths of Elan's
Zonegran; Providing Flexible Dosing Options For Improved Management of
Patients
Business Editors
UK REGULATORY NEWS
DUBLIN, Ireland--(BUSINESS WIRE)--Aug. 29, 2003--
Elan Corporation, plc (NYSE: ELN) ("Elan") today announced that it has
received approval from the U.S. Food and Drug Administration ("FDA")
to market two new lower dosage strengths, 25 mg and 50 mg, of
Zonegran(R) (zonisamide) in addition to the original 100 mg capsule.
Zonegran is indicated as adjunctive therapy for the treatment of
partial seizures in adults with epilepsy. The 25 mg and 50 mg capsules
of Zonegran will be manufactured by Elan at its recently completed
strategic Manufacturing, Global Services and Operations facility,
based in Athlone, Ireland. Manufacture of the 100 mg has recently
being transferred to the Athlone facility from the previous
third-party contract manufacturer. Elan expects to launch the new
dosage strengths in the fourth quarter of 2003.
"The FDA approval of the 25 mg and 50 mg doses of Zonegran enhances
the position of Zonegran in the epilepsy market," said Lars Ekman, MD,
PhD, Executive Vice President and President, Research and Development
at Elan. "With the availability of 25 mg and 50 mg strengths,
physicians now have the benefit of more flexible dosing options to
better manage patients and achieve effective seizure control."
Epilepsy is estimated to affect over two million people in the United
States. There is no known cure for epilepsy, but medication, including
antiepileptic drugs ("AEDs") such as Zonegran, controls seizures in
many people. Zonegran is well tolerated and the side effects are
generally mild to moderate and dose related. The most common side
effects associated with Zonegran include somnolence (sleepiness),
dizziness, anorexia, headache, nausea and agitation/irritability. Few
drug-to-drug interactions are likely with Zonegran. For complete
prescribing information, please visit www.elan.com.
Zonegran was developed in Japan and in the United States by Dainippon
Pharmaceuticals Company Limited ("Dainippon") of Osaka, Japan. Elan
licensed the sales and marketing rights for Zonegran from Dainippon
for North America and Europe. Elan expects to file a European
Marketing Authorisation Application for Zonegran for use as adjunctive
therapy in partial seizures in epilepsy by the end of this year.
Elan is focused on the discovery, development, manufacturing, selling
and marketing of novel therapeutic products in neurology, pain
management and autoimmune diseases. 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
judgement 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 these new lower dosage strengths of Zonegran will be
successfully manufactured, launched or marketed. A further list of
these risks, uncertainties and other matters can be found in Elan's
Annual Report on Form 20-F for the fiscal year ended December 31,
2001, and in its Reports of Foreign Issuer on Form 6-K. Elan assumes
no obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Short Name: Elan Corporation, plc
Category Code: MSC
Sequence Number: 00009037
Time of Receipt (offset from UTC): 20030829T123624+0100
--30--AC/ny* jgm/ny
CONTACT: Investors: (U.S.)
Jack Howarth, 212-407-5740
800-252-3526
or
Investors: (Europe)
Emer Reynolds, 353-1-709-4000
00800 28352600
or
Media:
Anita Kawatra, 212-331-8800
646-244-4773
KEYWORD: IRELAND INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MANUFACTURING MEDICAL MEDICAL DEVICES GOVERNMENT
SOURCE: Elan Corporation, plc
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