AstraZeneca PLC
18 January 2006
TOPROL-XL(R) (metoprolol succinate): ASTRAZENECA TO APPEAL DECISION IN U.S.
PATENT LITIGATION
AstraZeneca today announced that it has received a decision of Judge Rodney
Sippel of the U.S. District Court for the Eastern District of Missouri in
litigation titled In Re Metoprolol Succinate Patent Litigation. This case is a
consolidation of the company's cases against defendants KV Pharmaceutical
Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and Eon Labs
Manufacturing, Inc. The decision was issued in response to motions by all
parties argued on November 16-17, 2005, regarding the validity, enforceability
and infringement of two of the U.S. patents associated with TOPROL-XL(R)
(metoprolol succinate) extended release tablets.
In its decision, the Court found that the patents asserted by AstraZeneca in
this litigation -- the compound patent (U.S. Patent Number 5,081,154; ) and the
composition patent (U.S. Patent Number 5,001,161) that cover TOPROL-XL(R) are
invalid. The Court also found that the patents asserted by AstraZeneca in the
litigation are unenforceable. AstraZeneca disagrees with and is disappointed by
these conclusions. The Company maintains that both patents are valid and
enforceable and will appeal the Court's decision. Both patents are due to expire
on September 17th 2007.
Sales for TOPROL-XL in the US in 2005 were $1,291 million. TOPROL-XL is a
registered trademark of the AstraZeneca group of companies.
TOPROL-XL (R) (metoprolol succinate) Extended-Release Tablets
TOPROL-XL(R) is a beta1-selective (cardioselective) adrenoceptor-blocking agent,
for oral administration, available as extended-release tablets. TOPROL-XL has
been formulated to provide a continuous release of metoprolol for once-daily
administration.
Indications for TOPROL-XL(R) include the treatment of hypertension, alone or in
combination with other antihypertensives; the long-term treatment of angina
pectoris; and the treatment of stable, symptomatic (NYHA Class II or III) heart
failure of ischemic, hypertensive, or cardiomyopathic origin.
Toprol-XL(R) is sold outside the US as Seloken-ZOK(R).
18 January 2006
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506
-End-
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