ADDERALL XR(R) - Litigation Update
January 18 2006 - 3:17PM
PR Newswire (US)
BASINGSTOKE, England and HAYWARD, California, January 18
/PRNewswire-FirstCall/ -- Shire plc
(LSE:SHPLSE:NASDAQ:LSE:SHPGYLSE:TSX:LSE:SHQ) and Impax
Laboratories, Inc. (OTC:IPXL) announce that, as published today on
the Court's electronic docket, the U.S. District Court of the
District of Delaware has granted the parties' request to extend
until January 26, 2006 the deadline for the parties to submit the
pretrial order. The Court also agreed to stay the matters of the
case pending settlement negotiations. The case is listed on the
docket as Shire Laboratories Inc. v. Impax Laboratories, Inc. and
is a patent infringement lawsuit involving Shire's U.S. patents
Nos. 6,322,819 and 6,605,300, in connection with Impax's attempt to
market a generic version of Shire's ADDERALL XR prior to the
expiration of those patents. Notes to Editors: SHIRE PLC Shire's
strategic goal is to become the leading specialty pharmaceutical
company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on central nervous system
(CNS), gastrointestinal (GI), general products (GP) and human
genetic therapies (HGT) - all being areas in which Shire has a
commercial presence. The structure is sufficiently flexible to
allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire believes that a
carefully selected portfolio of products with a strategically
aligned and relatively small-scale sales force will deliver strong
results. Shire's focused strategy is to develop and market products
for specialty physicians. This approach aims to deliver increased
returns and lower risks. Shire's in-licensing and merger and
acquisition efforts are focused on products in niche markets with
strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's
website: http://www.shire.com/. "SAFE HARBOR" STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements
included herein that are not historical facts are
forwarding-looking statements. Such forward-looking statements
involve a number of risks and uncertainties and are subject to
change at any time. In the event such risks or uncertainties
materialize, Shire plc's results could be materially affected. The
risks and uncertainties include, but are not limited to; risks
associated with the inherent uncertainty of pharmaceutical
research, product development, manufacturing and commercialization;
the impact of competitive products, including, but not limited to,
the impact of those on Shire plc's Attention Deficit and
Hyperactivity Disorder ("ADHD") franchise; patents, including but
not limited to, legal challenges relating to Shire plc's ADHD
franchise; government regulation and approval, including but not
limited to the expected product approval dates of DAYTRANA(TM)
(MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD),
MESAVANCE(TM) (SPD476) (ulcerative colitis), ELAPRASE(TM)
(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its
scheduling classification by the Drug Enforcement Administration in
the United States; Shire plc's ability to benefit from the
acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to
secure new products for commercialization and/or development; and
other risks and uncertainties detailed from time to time in Shire
plc's and its predecessor registrant Shire Pharmaceuticals Group
plc's filings with the US Securities and Exchange Commission,
including Shire Pharmaceuticals Group plc's Annual Report on Form
10-K for the year ended December 31, 2004. IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded
products. IMPAX markets its generic products through its Global
Pharmaceuticals division and intends to market its branded products
through the IMPAX Pharmaceuticals division. Additionally, where
strategically appropriate, IMPAX has developed marketing
partnerships to fully leverage its technology platform. IMPAX
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward and Philadelphia
facilities. For more information, please visit the Company's Web
site at: http://www.impaxlabs.com/. DATASOURCE: Shire plc and Impax
Laboratories, Inc CONTACT: Investor Relations: Clea Rosenfeld (Rest
of the World), +44-1256-894-160; Brian Piper (North America),
+1-484-595-8252, Media, Jessica Mann (Rest of the World),
+44-1256-894-280, Matthew Cabrey (North America), +1-484-595-8248;
For further information on Impax please contact: Barry R. Edwards,
+1-215-933-0360, Larry Hsu, Ph.D., +1-510-476-2000, Ext. 1111,
Arthur Koch, +1-215-933-0351, http://www.impaxlabs.com/ Or Investor
Relations Contacts: Lippert/Heilshorn & Associates, Inc. Kim
Sutton Golodetz, +1-212-838-3777, , or Bruce Voss, +1-310-691-7100,
, http://www.lhai.com/
Copyright