1st Dec 2005 16:30
Shire files idursulfase with EMEA for treatment of Hunter syndrome Basingstoke, UK and Philadelphia, PA, US,- December 1, 2005 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it hassubmitted a Marketing Authorization Application (MAA) to the European MedicinesAgency (EMEA) for idursulfase for the treatment of Hunter syndrome. Review of a MAA by EMEA typically takes 12 months. If approved, this would be the first human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II)."Following last week's filing in the United States, our MAA filing with theEMEA is another key milestone in bringing to market a treatment for patientsand families around the world living with Hunter syndrome," said Dr. David D.Pendergast, executive vice president and general manager of Shire Human GeneticTherapies, the Shire specialty unit focused specifically on genetic diseases."I look forward to approval and subsequent launch in Europe in late 2006 orearly 2007."As previously announced, Shire filed idursulfase under the tradename ELAPRASETMwith the U.S. Food and Drug Administration (FDA) on November 23, 2005 under aFast Track designation and has requested Priority Review of that submission,which would result in a six-month FDA review.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 editorsAbout Hunter Syndrome and idursulfaseHunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare,life threatening, genetic disorder with no available treatment. Individualswith Hunter syndrome lack the enzyme iduronate-2-sulfatase, which is essentialin the continuous process of replacing and breaking down glycosaminoglycans(GAG). As a result, GAG remains stored in cells in the body causing progressivedamage. The symptoms of Hunter syndrome are usually not visible at birth, butusually start to become noticeable after the first or second year of life.Often the first symptoms may include hernias, frequent ear infections, runnynoses, reduced growth rate and abnormal facial appearance.As the disease progresses, a variety of symptoms appear including enlargedliver and spleen, heart failure, decreased endurance, obstructive andrestrictive airway disease, sleep apnea, joint stiffness, and, in some cases,central nervous system involvement. If central nervous system involvementexists, the life expectancy for patients with Hunter syndrome is typically10-15 years of age, however, some patients can survive into the fifth or sixthdecade of life. There is currently no effective therapy for Hunter syndrome.Idursulfase is a human iduronate-2-sulfatase produced by genetic engineeringtechnology, developed to replace the missing enzyme in Hunter syndromepatients. Idursulfase has been designated an orphan drug in both the UnitedStates and in the European Union.Shire believes there are approximately 2,000 patients worldwide afflicted withHunter syndrome in countries where reimbursement may be possible.Shire is committed to helping patients and families with Hunter syndrome.Further information about Hunter syndrome is available at http://www.hunterpatients.com.SHIRE 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. # # # This assumes approval - I think the qualified wording in the first paragraphworks, but the "if approved" would be awkward for the headline.I believe that we will change to Shire plc as of next week so maybe needschanging, depending on timing of issue.Have we gotten approval of the tradename yet? If not, we may want tore-consider using it in the release. We should discuss on the call.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 Pharmaceuticals Group PLCRelated Shares:
Shire