Galen Holdings PLC
21 December 2001
Craigavon, Northern Ireland/Rockaway, NJ December 21, 2001
Galen submits New Drug Application for Intravaginal Ring to US Food and Drug
Craigavon, Northern Ireland, UK / Rockaway, New Jersey, USA...December 21,
2001...Galen Holdings PLC (LSE: GAL.L, Nasdaq: GALN) today announced that it
has completed the submission of its New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for its intravaginal ring estrogen
replacement therapy, Estrace VR(R).
The product, for hormone replacement therapy, was approved for use in the
United Kingdom earlier this year and is marketed under the brand name Menoring
(R). Submission to the European regulatory authorities via the Mutual
Recognition Procedure is in progress.
Roger Boissonneault, Chief Executive of Galen Holdings, said: 'The submission
of the NDA is an important step towards the commercialisation of our IVR drug
delivery platform in the United States. We look forward to working with the
various regulatory authorities over the coming months.'
Notes to Editors
Galen is an integrated specialty pharmaceutical company based in Craigavon,
Northern Ireland and Rockaway, New Jersey, USA. Galen develops, acquires and
manufactures branded prescription pharmaceutical products which are promoted
by the Company's sales and marketing organizations in the UK, Ireland and the
US. Galen's Pharma Services division supplies and distributes clinical trial
materials internationally, operates a drug reconciliation business and
provides computer-based interactive voice response systems to permit
theefficient management of worldwide clinical trials. The Pharma Services
division also provides 'bench-to-pilot-scale' custom chemical design and
synthesis services to the research-based pharmaceutical industry.
Statements made in this press release include forward-looking statements made
pursuant to the safe harbor provisions of the Securities Litigation Reform Act
of 1995. Such statements, including those relating to financial expectations
for the fiscal year 2001 and beyond, involve certain risks and uncertainties
that could cause actual results to differ materially from those in the forward
looking statements, including, but not limited to, the company's dependence on
key products, risks associated with product development and manufacturing, the
uncertainty of future financial results and fluctuations in operating results,
dependence on the Company's acquisition strategy, new product introductions,
currency fluctuations and other risks described from time to time in the
Company's SEC filings. These forward-looking statements represent the
judgment of the Company, as of the date of this release, and the Company
disclaims any intent or obligation to update these forward-looking statements.
Information on other significant potential risks and uncertainties not
discussed herein may be found in the Company's filings with the Securities and
Exchange Commission including its Form 20F for the year ended September 30,
2000, when filed, and all information previously filed by the Company's
wholly-owned subsidiary, Warner Chilcott plc, including Warner Chilcott plc's,
definitive proxy statement filed with the SEC on August 8, 2000.
Dr. John King, Chairman, Galen Holdings PLC
Craigavon, Northern Ireland, UK
Roger Boissonneault, CEO, Galen Holdings PLC
Rockaway, New Jersey, USA
Andrew Dowler/Fiona Noblet, Financial Dynamics