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Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR

June 23, 2012

PHILADELPHIA, June 23, 2012 /PRNewswire/ –

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company,
announces that on June 22, 2012, the US Food and Drug Administration (FDA) responded to
Shire’s Adderall XR citizen petition. The FDA’s response requires that all abbreviated new
drug applications (ANDAs) have to establish bioequivalence using partial area under the
curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA
response is consistent with its recent decisions on other long acting ADHD products.

The FDA also informed Shire on June 22, 2012 that it has approved the ANDA for generic
Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.

Shire believes that it will remain competitive in the Adderall XR marketplace through
the distribution of branded Adderall XR and through its two authorized generic partners,
Teva and Impax. While recognizing that there will be multiple dynamics affecting the
overall market following the approval of the Actavis generic, Shire continues to believe
that it will deliver good, full year 2012 earnings growth.

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, human genetic therapies, gastrointestinal
diseases and regenerative medicine 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 Pharmaceuticals, Human Genetic Therapies and
Regenerative Medicine products, as well as the ability to secure 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 (Corporate)
        jmann@shire.com
        +44-1256-894-280

        Gwen Fisher (Specialty Pharma)
        gfisher@shire.com
        +1-484-595-9836

SOURCE Shire plc


Source: PR Newswire