Navigation Links
Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
Date:10/13/2009

PHILADELPHIA, October 13 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.

The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR(R) in the United States beginning upon approval of its own generic products by the FDA, and Sandoz will pay Shire a royalty from those sales. To date, the US Food and Drug Administration has not approved any generic version of ADDERALL XR(R). No payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remain the only authorized generic supplier of ADDERALL XR.

The litigation involves a patent infringement lawsuit covering Shire's U.S. patents Nos. 6,322,819 ("the '819 Patent"), and 6,605,300 ("the '300 Patent"). As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire's '819 and '300 Patents and that the two patents are valid and enforceable.

Resolution of the case against Sandoz ends all litigation against generic ANDA applicants over ADDERALL XR(R).

The agreements, which are effective immediately, have been submitted to the US Federal Trade Commission for its review as required by law.

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.

"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 (Specialty Pharma)  +1-484-595-8248


SOURCE Shire Plc


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

Related medicine technology :

1. Veriscrip and DAMMAD Team Up to Combat Prescription Drug Abuse in New Hampshire
2. New Hampshire Rx Card Launching Statewide
3. Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
4. Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
5. Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
6. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
7. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
8. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
9. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
10. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
11. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
Breaking Medicine News(10 mins):