Shire Files Lawsuits Against Watson and Roxane for Infringement of VYVANSE (lisdexamfetamine dimesylate) Patents
DUBLIN, July 7,
2011/PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY),
the global specialty biopharmaceutical company, announces that it
has filed lawsuits in the U.S. District Court for the District of
New Jersey against Roxane Laboratories, Inc., ("Roxane"), and in
the U.S. District Court for the Central District of California
against Watson Laboratories, Inc., ("Watson"), respectively, for
infringement of certain of Shire's VYVANSE patents.
The lawsuits were
initiated in response to Abbreviated New Drug Applications
("ANDAs") filed by each of Roxane and Watson seeking FDA approval
to market and sell generic versions of all currently approved doses
of VYVANSE.
Under the
Hatch-Waxman Act, the FDA must refrain from approving the Roxane
and Watson ANDAs before August 23, 2014, or until a district court
decision finding that the patents are invalid or not infringed,
whichever occurs earlier.
Shire will provide
details of any additional Paragraph IV certifications received
advising of ANDA filings on VYVANSE, and any litigation that is
subsequently initiated, in its periodic filings on Forms 10-Q and
10-K.
Notes to
editors
SHIRE PLC
Shire's strategic
goal is to become the leading specialty biopharmaceutical company
that focuses on meeting the needs of the specialist physician.
Shire focuses its business on attention deficit hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal
(GI) diseases as well as opportunities in other therapeutic areas
to the extent they arise through acquisitions. Shire's
in-licensing, merger and acquisition efforts are focused on
products in specialist markets with strong intellectual property
protection and global rights. Shire believes that a carefully
selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong
results.
For further
information on Shire, please visit the Company's website:
http://www.shire.com.
"SAFEHARBOR"
STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995
Statements included
herein that are not historical facts are forward-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, the Company's
results could be materially adversely affected. The risks and
uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceuticals and Human Genetic Therapies products, as
well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the
Company's products; the Company's ability to manufacture its
products in sufficient quantities to meet demand; the impact of
competitive therapies on the Company's products; the Company's
ability to register, maintain and enforce patents and other
intellectual property rights relating to its products; the
Company's ability to obtain and maintain government and other
third-party reimbursement for its products; and other risks and
uncertainties detailed from time to time in the Company's filings
with the Securities and Exchange Commission.
For further information please contact:
Investor Relations
Eric Rojas (erojas@shire.com) +1-781-482-0999
Sarah Elton-Farr (seltonfarr@shire.com) +44-1256-894157
Media
Jessica Mann (jmann@shire.com) +44-1256-894-280
Matthew Cabrey (mcabrey@shire.com) +1-484-595-8248
Source: Shire plc
.
Posted: July 2011
