Update on velaglucerase alfa
In the U.S., the velaglucerase alfa treatment protocol is currently openand enrolling patients. In the EU and other regions, Shire is engaging withnational and regional authorities to seek pre-approval access using thefastest mechanisms available in each region. Shire will manage, on an ongoingbasis, the overall global supply of velaglucerase alfa based on the evolvingneed as communicated to us by physicians.
Shire has accelerated its manufacturing timeline by almost 18 months inorder to provide velaglucerase alfa for the long-term treatment of Gaucherpatients during 2009 and beyond. Shire currently has supply of velaglucerasealfa for several hundred patients world-wide. The total number of patientsShire can treat is dependent on the patient weight, as well as theadministered dose as recommended by their treating physician; Shire estimatesthis could translate into a range of 300 to 600 patients for uninterruptedtreatment starting in September 2009. Shire also expects that several hundredmore patients can be added throughout 2010; the range will again depend onpatient weight, and doses.
Shire is working with a global group of experienced Gaucher physicians toensure that physicians put in place guidelines that consider patients in thegreatest need of treatment during the supply crisis. Individual treatmentdecisions will remain with the patient's physician.
In addition, Shire is working with regulatory authorities towards theapproval of velaglucerase alfa and has announced, earlier last week, thatbased on the positive results from all phase 3 trials, it has submitted theNew Drug Application to the U.S. Food & Drug Administration and is expectedto submit the EU application by year end.
In order to help physicians plan with their patients, Shire has todaysent a letter to physicians in the U.S. This letter is to be posted onhttp://www.gaucherpatients.com.
Notes to editors
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned 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 REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.For further information please contact: Investor Relations Clea Rosenfeld (Rest of the World) +44-1256-894-160 Eric Rojas (North America) +1-617-551-9715 Media Jessica Mann (Rest of the World) +44-1256-894-280 Jessica Cotrone (North America) +1-617-613-4640
SOURCE Shire Plc
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