7th Dec 2005 18:22
Shire announces New River Pharmaceuticals filing of NRP104Philadelphia, US and Basingstoke, UK - December 7, 2005 -- Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announced today that New River Pharmaceuticals, Inc.(NRP) has filed with the U.S. Food and Drug Administration (FDA) a new drugapplication (NDA) for the investigational compound NRP104 for the treatment ofattention deficit hyperactivity disorder (ADHD) in pediatric populations (ages6-12)."The filing of NRP104 is excellent news for both Shire and New River," saidShire Chief Executive Officer Matthew Emmens. "We are pleased that thisapplication has been submitted on schedule and we look forward to working withNew River toward an approval and subsequent launch in 2006."Shire and New River signed a collaborative agreement to develop andcommercialize NRP104 on January 31, 2005. Under the terms of the agreement, theparties collaborate on NRP104 development, manufacturing, marketing and salesin the US. Upon launch, Shire will book the product sales and New River maysupply up to 25% of the sales effort under a co-promotion right. New River willbe financially and operationally responsible for clinical and manufacturingdevelopment.Upon FDA approval, the parties will divide operating profit in accordance withthe following general principles: Shire will retain 75% of profits for thefirst two years following launch and the parties will share the profits equallythereafter.Outside the U.S., Shire has a license to develop and commercialize NRP104 andNew River will receive a low double-digit royalty on net sales.Shire paid an initial sum of US$50 million to NRP upon signing of theagreement. An additional US$50 million will be due to NRP upon acceptance offiling of the NDA by the FDA, typically within 60 days of receipt of filing.Additionally, up to US$300 million in milestone payments will be due to NewRiver depending on the characteristics of the FDA-approved product labeling. Anadditional US$100 million milestone would be payable as a sales bonus uponachieving a significant sales target. Shire plans to expense the second US$50million payment during the course of the first quarter 2006, and currentlyexpects to capitalize and amortize the potential remaining milestone paymentsand the potential sales bonus over the life of the product. -ends- For further information please contact:Investor Relations Clĩa Rosenfeld (Rest of the World) +44 1256 894 160 Brian Piper (North America) +1 484 595 8252 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248 Notes to editorsSHIRE PLCShire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on central nervous system, gastrointestinal, generalproducts and human genetic therapies - all being areas in which Shire has acommercial presence. The structure is sufficiently flexible to allow Shire totarget new therapeutic areas to the extent opportunities arise throughacquisitions. Shire believes that a carefully selected portfolio of productswith strategically aligned and relatively small-scale sales forces will deliverstrong results. Shire's strategy is to develop and market products forspecialty physicians. Shire's in-licensing and merger and acquisition effortsare focused on products in niche markets with strong intellectual propertyprotection either in the US or Europe.For further information on Shire, please visit the Company's website:www.shire.com."SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995Statements included herein that are not historical facts are forwarding-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risksor uncertainties materialize, Shire plc's results could be materiallyaffected. The risks and uncertainties include, but are not limited to; risksassociated with the inherent uncertainty of pharmaceutical research, productdevelopment, manufacturing and commercialization; the impact of competitiveproducts, including, but not limited to, the impact of those on Shire plc'sAttention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents,including but not limited to, legal challenges relating to Shire plc's ADHDfranchise; government regulation and approval, including but not limited to theexpected product approval dates of DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503(ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;Shire plc's ability to benefit from the acquisition of Transkaryotic TherapiesInc.; Shire plc's ability to secure new products for commercialization and/ordevelopment; and other risks and uncertainties detailed from time to time inShire plc's and its predecessor registrant Shire Pharmaceuticals Group plc'sfilings with the US Securities and Exchange Commission, including ShirePharmaceuticals Group plc's Annual Report on Form 10-K for the year endedDecember 31, 2004. # # # Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom Tel +44 (0)1256 894000 Fax +44 (0)1256 894708 www.shire.com Press Release ENDSHIRE PLCRelated Shares:
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