Navigation Links
Shire plc - Statement re ProAmatine
Date:8/17/2010

Shire plc - Statement re ProAmatine -- PHILADELPHIA, Pennsylvania, August 17, 2010 /PRNewswire-FirstCall/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Acquisitions, Mergers and Takeovers, Clinical Trials & Medical Discoveries, FDA Approval Click to view news release full screen  

Shire plc - Statement re ProAmatine

 

PHILADELPHIA, Pennsylvania, August 17, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999 and Shire conducted and completed the post marketing trials that the FDA required. The FDA, however, viewed these trials as inconclusive and required that additional trials be conducted for ProAmatine to maintain its marketing authorization. As a result, Shire elected to withdraw the product effective September 30, 2010 and notified the FDA in November 2009 and healthcare professionals earlier this year of this decision. Shire's withdrawal of the NDA was not related to any concerns regarding the safety of ProAmatine.

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: Media Matthew Cabrey (mcabrey@shire.com) +1-610-613-2790 Ben Atwell (Ben.Atwell@fd.com) +44-020-7269-7242
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Shire Proposes to Expand Specialist Gastrointestinal Portfolio
2. Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
3. Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
4. Shire plc Appoints Two New Board Directors
5. INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
6. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
7. INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
8. Shires Replenished Portfolio Drives Excellent Quarterly Performance
9. Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals
10. Shire Supports Rare Disease Day 2010
11. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... YORK , May 26, 2016 ... today that it will be a featured presenter at the ... in New York City at the ... Denis Corin , Q BioMed Inc. CEO, is scheduled to ... will cover the company,s business strategy, recent developments and outline ...
(Date:5/26/2016)... ... May 26, 2016 , ... Kinder Scientific (KinderScientific.com), ... developments that position the Company for the future. Kinder Scientific announces restructured ... Kinghorn has been appointed Chairman of the Board, Curtis D. Kinghorn has been ...
(Date:5/25/2016)... ... May 25, 2016 , ... Thailand’s Board of Investment’s ... in San Francisco. Located at booth number 7301, representatives from the Thai Government, ... discuss the Thai biotechnology and life sciences sector. , Deputy Secretary General ...
(Date:5/25/2016)... ... 2016 , ... The American Medical Informatics Association (AMIA) responded ... Coordinator for Health IT (ONC) outlining a measurement approach to interoperability that focuses ... and where it was needed. The organization of health informatics professionals said a ...
Breaking Biology Technology:
(Date:3/15/2016)... New York , March 15, 2016 ... new market report published by Transparency Market Research "Digital Door ... Trends and Forecast 2015 - 2023," the global digital door ... US$ 731.9 Mn in 2014 and is forecast to grow ... 2023. Growth of micro, small and medium enterprises (MSMEs) across ...
(Date:3/11/2016)... http://www.apimages.com ) - --> http://www.apimages.com ) - ... Images ( http://www.apimages.com ) - Germany . ... new refugee identity cards. DERMALOG will be unveiling this device, and ... Hanover next week.   --> Germany ... the new refugee identity cards. DERMALOG will be unveiling this device, ...
(Date:3/9/2016)... NEW YORK , March 9, 2016 ... current and future states of the RNA Sequencing (RNA ... in segments such as instruments, tools and reagents, data ... Analyze various segments of the RNA-Sequencing market such ... RNA-Sequencing services Identify the main factors affecting each segment ...
Breaking Biology News(10 mins):