Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - Shire plc | dp15339_8k.htm |
Exhibit
99.01
|
Press
Release
www.shire.com
|
 |
FDA
Determines VYVANSE® was
Properly Granted Five-Year Market Exclusivity
DUBLIN, IRELAND - October 26,
2009 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that the Food and Drug Administration
(FDA), following a thorough administrative review of governing statutory and
regulatory standards and public comments, has affirmed its prior decision to
grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine
dimesylate—currently marketed by Shire U.S. Inc. for the treatment of
attention-deficit hyperactivity disorder under the name VYVANSE®. The
five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE
is covered by United States patents which remain in effect until June 29,
2023.
On
February 23, 2007, after reviewing the requisite clinical studies submitted on
behalf of VYVANSE, the FDA determined that VYVANSE qualified as a NCE and was
entitled to five-year market exclusivity. The FDA therefore
appropriately refused to file the Abbreviated New Drug Application submitted by
Actavis Elizabeth, LLC (Actavis) for generic lisdexamfetamine dimesylate in
January 2009. On February 24, 2009, Actavis sued the FDA in the
District Court of the District of Columbia challenging the NCE
decision. On April 13, 2009, the FDA opened a public docket to
consider Actavis’s challenge to the FDA’s regulations governing NCE exclusivity
and the corresponding award of exclusivity to VYVANSE. The court case
was stayed pending the outcome of this FDA review.
For
further information please contact:
|
Investor
Relations
|
Cléa
Rosenfeld (Rest of the World)
|
+44 1256 894
160
|
|
Eric Rojas
(North America)
|
+1 617 551
9715
|
|
|
Media
|
Jessica Mann
(Rest of the World)
|
+44 1256 894
280
|
|
Matthew
Cabrey (North America)
|
+1 484 595
8248
|
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 Web site: http://www.shire.com.
Registered
in Jersey, No. 99854, 22
Grenville Street, St
Helier, Jersey JE4
8PX
THE
“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.