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:1/13/2017)... , Jan. 13, 2017 Eli Lilly and ... (NASDAQ: INCY ) announced today that the ... review period for the new drug application (NDA) for ... of moderate to severe rheumatoid arthritis (RA). The NDA ... 2016. The FDA extended the action date ...
(Date:1/13/2017)... York , January 13, 2017 ... prevalence of AIDS will collectively contribute to the demand for ... to reach a value of US$ 551.0 Mn by 2016 ... will remain the most lucrative markets for western blotting, whereas ... the market globally. ...
(Date:1/13/2017)... cattle, leafy greens and rosy cheeked children share space in ... the food industry,s shift from response to prevention. ... Swab Rinse Kit (SRK™) is an efficient, ... wake of the new FDA Food Safety Modernization Act ... expanding the U.S. production of the SRK line at our ...
Breaking Medicine Technology:
(Date:1/15/2017)... ... 2017 , ... Wondering where to go this Valentine's Day? Well, there is ... a romantic, lobster feast in the comfort of your own home. Lobster Gram is ... will be featured until February 15th, 2017. , Romantic Dinner one is Lobster ...
(Date:1/14/2017)... Saint Petersburg, Florida (PRWEB) , ... January 14, 2017 , ... ... The Emoji Scale. , The Emoji Scale is now available on Apple as ... to give emoji ratings simply by choosing one of the ten color coded values ...
(Date:1/13/2017)... ... 13, 2017 , ... KOAMTAC ®, Inc., a leading manufacturer of Bluetooth ... companion scanner and data collector at the National Retail Federation’s Big Show (NRF17) held ... answer to the market’s need for more compact and rugged devices for collecting barcode ...
(Date:1/13/2017)... (PRWEB) , ... January 13, 2017 , ... "We wanted ... attractive to wear," said one of two inventors from Virginia Beach, Va. , They ... normally mundane braces. , The accessories allow braces to be customized to suit ...
(Date:1/13/2017)... ... January 13, 2017 , ... As the nation watches ... of deans of colleges and schools of education across the country is urging a ... a Declaration of Principles released today, 175 deans sounded the alarm: “Our children suffer ...
Breaking Medicine News(10 mins):