Navigation Links
FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity
Date:10/26/2009

DUBLIN, October 26 /PRNewswire-FirstCall/ -- 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(R). 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.

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.

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.

    For further information please contact:

    Investor       Clea Rosenfeld (Rest of the World) +44-1256-894-160
    Relations      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


SOURCE Shire Plc


'/>"/>
SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD
2. Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
3. New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)
4. Dallas Researchers Find Compression Stockings Improperly Used
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
7. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
8. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
9. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
10. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
11. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... DUBLIN , May 4, 2016 /PRNewswire/ ... the addition of the  "Global Multiple Myeloma ...  report to their offering.       ... Multiple Myeloma Market and Competitive Landscape Highlights ... pipeline products, Multiple Myeloma epidemiology, Multiple Myeloma ...
(Date:5/4/2016)... Research and Markets has ... Keratosis Market and Competitive Landscape Highlights - ...      (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ... Highlights 2016, provides comprehensive insights into Actinic ... Keratosis market valuations and forecast, Actinic Keratosis ...
(Date:5/3/2016)... May 3, 2016 BioNovus Innovations LLC ... for Advancing Medical Innovation (IAMI) today announced a ... diagnostics and medical devices. An agreement ... rights to license, develop and commercialize medical innovations ... "This partnership represents a significant advance in ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... The Lymphoma ... innovative lymphoma research and serving the lymphoma community through a comprehensive series of ... the esteemed Quaker Ridge Golf Club in Scarsdale, New York on May 23, ...
(Date:5/4/2016)... ... May 04, 2016 , ... The Spiritual Care ... recognize chaplains for their valuable support to patients and their families, and their overall ... , To mark Spiritual Care Day, SCA has sent “Thank You Chaplain” cards with ...
(Date:5/4/2016)... ... , ... Hight-Doland Insurance Agency’s new community involvement program which serves families of ... of Southwest Louisiana to help provide positive mentoring for local youth. Donations to this ... of Southwest Louisiana has been helping to guide the area’s youth for over 30 ...
(Date:5/4/2016)... Island (PRWEB) , ... May 04, 2016 , ... ... in April 2016. SS&A teamed up with one of the top website design ... information portal contains informative legal articles related to the law firm's main practice ...
(Date:5/4/2016)... ... May 04, 2016 , ... Recognizing that lifestyle medicine is essential ... Verywell, have tapped David Katz, MD, MPH, president of the American College of ... to lifestyle medicine is especially gratifying,” said Katz. “There is so much opportunity to ...
Breaking Medicine News(10 mins):