Shire Receives New Paragraph IV Notice Letter From Watson for ADDERALL XR(R)
/PRNewswire-FirstCall/ — Shire plc (LSE: SHP, NASDAQ: SHPGY), the global
specialty biopharmaceutical company, announces that its subsidiaries Shire
LLC and Shire Development Inc. (collectively “Shire”) have received a new
Paragraph IV Notice Letter from Watson Laboratories, Inc. in
Florida
Application (“ANDA”) for a generic version of all approved strengths of
Shire’s ADDERALL XR(R) (mixed salts of a single-entity amphetamine product)
dextroamphetamine sulphate, dextroamphetamine saccharate, amphetamine
aspartate monohydrate, amphetamine sulphate capsules, CII.
The new ANDA that
settlement agreements entered into in
(the “Settlement Agreements”). The Settlement Agreements cover a different
ANDA and do not provide any license for
in
ADDERALL XR(R) is protected by the following FDA Orange Book listed
patents: U.S. Reissued Patent RE41,148, which is a reissue of U.S. Patent No.
6,605,300, and U.S. Patent No. 6,322,819, which has recently reissued as U.S.
Reissued Patent RE42,096.
Patent protection will expire in
Shire is currently reviewing the details of
Letter which was directed to each of the Orange Book listed patents. Under
the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice Letter
to determine if it will file a patent infringement suit. If Shire brings suit
pursuant to the Hatch Waxman regulations, a stay of approval of up to
30-months will be imposed by the FDA on
Shire submitted a Citizen Petition (CP) to the FDA in
requesting that the FDA impose stricter bioequivalence standards before
approving any ANDA for ADDERALL XR(R). The FDA responded that the CP raised
“complex issues” and has not resolved the matter. The FDA has not approved
any ANDA for ADDERALL XR(R).
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.
“SAFE HARBOR” 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 Pharmaceutical 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
Media Jessica Mann (jmann@shire.com) +44-1256-894-280
Matthew Cabrey (mcabrey@shire.com) +1-484-595-8248
SOURCE Shire plc