Navigation Links
Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan
Date:2/9/2009

PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, February 9 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), announces that it has received Paragraph IV Notice letters from Barr Laboratories, Inc. ("Barr) and Mylan, Inc. ("Mylan) dated 2 and 4 February 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of 500mg, 750mg and 1gm FOSRENOL(R), (lanthanum carbonate).

FOSRENOL is protected by three FDA Orange Book listed patents: U.S. patent No. 5,968,976, Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates; U.S. patent No. 7,381,428, Stabilized Lanthanum Carbonate Compositions; and U.S. patent No. 7,465,465, Pharmaceutical Formulation Comprising Lanthanum Compounds which expire in 2018, 2024 and 2024 respectively. Shire believes these patents provide a robust and sustainable proprietary position for FOSRENOL under U.S. patent laws.

Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act, has 45 days from the date of each notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Barr's and Mylan's ANDA, which will commence on 26 October 2009.

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.

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.


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

Related biology technology :

1. Shire plc: Change to Directors Details
2. Shire Successfully Settles Former TKT Shareholder Appraisal Rights Litigation
3. Shires New Product Portfolio Delivers Strong Quarterly Performance
4. Change of Name to Shire plc
5. Shire Announces Holding of 81% in Jerini AG and Publication of Offer Document
6. Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.
7. Shire Re-Launches ADHDSupport.com, a Virtual Road Map Providing Information, Tools and Practical Tips About Attention Deficit Hyperactivity Disorder (ADHD)
8. Shire Ltd.: Robin Buchanan to Step Down as Non-Executive Director on Completion of Term of Office
9. Shire Ltd - Second Quarter 2008 Results Date Notification - 31 July 2008
10. Graham Hetherington Appointed Chief Financial Officer and Board Director at Shire
11. Application for Listing of Shire Limited Ordinary Shares
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... -RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" ... clinical data from its phase 1/2 tendon repair study investigating ... (RCT-01) as a treatment for Achilles tendinosis. ... The clinical trial ... 6 months and showed no serious adverse events related to ...
(Date:3/28/2017)... ... ... Executive search firm, Slone Partners, announces the placement of ... distinguished life sciences expert with a proven track record in strategic global business ... of services related to laboratory testing and analysis for the pharmaceutical, medical device, ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... the fight against cancer, autoimmune disease and more through a single-cell precision engineering ... and proteomics analysis platform developed in the laboratory of Dr. James Heath ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... generally produce small, heterogeneous samples with limited tumor content in a large background ... be resolved, such as the need for reliable detection of low abundance somatic ...
Breaking Biology Technology:
(Date:3/1/2017)... 1, 2017  Aware, Inc. (NASDAQ: AWRE), a leading ... Richard P. Moberg has resigned, effective March 3, ... Financial Officer and Treasurer of Aware citing a desire ... a member of the Board of Directors of Aware. ... Executive Officer and co-President, General Counsel has been named ...
(Date:2/26/2017)... -- Securus Technologies, a leading provider of civil and ... corrections and monitoring, announces the appointment of a ... often, too many offenders return to jail or ... to tackle this ongoing problem and improve the ... significant steps are underway, Securus continues to invest ...
(Date:2/16/2017)... , Feb. 16, 2017  Genos, a ... announced that it has received Laboratory Accreditation from ... Accreditation is presented to laboratories that meet stringent ... demonstrate scientifically rigorous processes. "Genos is ... in laboratory practices. We,re honored to be receiving ...
Breaking Biology News(10 mins):