1st Dec 2014 12:30
SHIRE PLC - Shire to Highlight Pipeline Progress in R&D DaySHIRE PLC - Shire to Highlight Pipeline Progress in R&D Day
PR Newswire
London, December 1
Shire to Highlight Pipeline Progress and Breadth of Innovative Portfolio in R&D Day Company to Profile Key Late-Stage Assets Projected to Drive $3 Billion in Growth by 2020 Lexington, MA - December 1, 2014 - Shire plc (LSE: SHP, NASDAQ: SHPG) announcestoday that it will host a live webcast in conjunction with its Research andDevelopment (R&D) Day on Wednesday, December 10, 2014, from 8:00 a.m. to 3:30p.m. EST at the Alexandria Center in New York City. Shire will provide an update to the investment community on the Company's R&Dpipeline, which is focused on innovative medicines to treat rare diseases andother specialty conditions. The R&D Leadership Team will highlight a number ofprograms in Shire's research portfolio, as well as provide updates on severalclinical programs in development, including SHP606 (lifitegrast) in Dry EyeDisease, SHP625 (LUM001) in Cholestatic Liver Disease, SHP626 (LUM002) foradults with Nonalcoholic Steatohepatitis (NASH), and SHP607 for the preventionof Retinopathy of Prematurity (ROP). Members of Shire's R&D Leadership Team, in conjunction with physicians, willprovide an update on the company's R&D strategy and pipeline, and the sciencebehind its current rare disease programs in Gastrointestinal/Hepatology,Ophthalmics, Complement Pathway Disorders and the Central Nervous System.Presentations will also include a review of the diseases these investigationalmedicines treat. Shire speakers scheduled to present include: Flemming Ornskov, MD, MPH, Chief Executive Officer, andPhil Vickers, Ph.D., Head of Research & Development. Presentations will also be delivered by key members of the research andclinical team, including: Howard Mayer, MD, Head of Clinical Development,Ciara Kennedy, Ph.D., Head of Cholestatic Liver Diseases,Norman Barton, MD, Global Development Team Lead, andAlbert Seymour, Ph.D., Head of Research and Nonclinical Development. These presentations will be broadcast via a live webcast that can be accessedunder the "Presentations & Webcasts" tab in the Investor Relations section ofthe Company's website at www.shire.com. A replay of the webcast will bearchived on the website following the presentation. The details of the Conference Call are as follows: UK Toll-Free Number: 08082370033UK and International Number: +44 (0) 2034262889US Toll Number: +16467224897US Toll-Free Number: 18778414559 For further information please contact: Investor RelationsJeff Poulton [email protected] +1 781 482 0945Sarah Elton-Farr [email protected] +44 1256 894157 MediaJessica Cotrone [email protected] +1 781 482 9538 NOTES TO EDITORS Shire enables people with life-altering conditions to lead better lives. Our strategy is to focus on developing and marketing innovative specialtymedicines to meet significant unmet patient needs. We focus on providing treatments in Neuroscience, Rare Diseases,Gastrointestinal, and Internal Medicine and we are developing treatments forsymptomatic conditions treated by specialist physicians in other targetedtherapeutic areas, such as Ophthalmics. www.shire.com THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACTOF 1995 Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, that: * Shire's products may not be a commercial success; * revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014; * the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations; * Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time; * the development, approval and manufacturing of Shire's products is subject to extensive oversight by various regulatory agencies. Submission of an application for regulatory approval of any of our product candidates, such as our planned submission of a New Drug Application to the FDA for Lifitegrast, may be delayed for any number of reasons and, once submitted, may be subjected to lengthy review and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches; * the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely impact Shire's revenues, financial condition or results of operations; * investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire's activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines; * adverse outcomes in legal matters and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations; * Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives; * failure to achieve Shire's strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire's financial condition and results of operations; and other risks and uncertainties detailed from time to time in Shire's filingswith the Securities and Exchange Commission, including those risks outlined in"Item 1A: Risk Factors" in Shire's Annual Report on Form 10-K for the yearended December 31, 2013. Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX Press Release www.shire.com
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