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Shire plc: Excellent Performance Across All Areas of the Business and Accelerating New Product Sales Drive Revenue Growth of 36%
Date:2/21/2008
Netherlands, as the reference member state for approval in the EU via the decentralized procedure, on December 12, 2007.
- INTUNIV(TM) (previously known as SPD503) - ADHD - A non-stimulant "non-scheduled" medication for the treatment of ADHD. In June 2007 Shire received an approvable letter from the FDA for INTUNIV. Shire is in discussions with the FDA regarding additional clinical work which is designed to enhance the label. While the precise timing of the approval of INTUNIV is unknown, Shire now anticipates that launch will occur in H2 2009.
- SPD465 - ADHD - In May 2007 Shire received an approvable letter from the FDA. Shire is not currently taking any steps to move this product towards approval.
- FOSRENOL - Hyperphosphatemia - On October 16, 2007 the FDA Cardiovascular and Renal Drugs Advisory Committee recommended by a majority vote the use of phosphate binders, including FOSRENOL, to treat hyperphosphatemia in CKD stage 4 patients. Shire is working with the FDA to explore the regulatory pathway to approval for use in pre-dialysis patients.
- LIALDA/MEZAVANT - Phase 3 worldwide clinical trials investigating the use of the product for the treatment of diverticulitis, a colonic disease, were initiated in 2007.
- ELAPRASE - for Hunter syndrome patients with significant central nervous system symptoms - In December 2007 Shire completed all pre-clinical work and filed an Investigational New Drug ("IND") application. The IND was accepted by the FDA on January 23, 2008.
- Velaglucerase alfa (GA-GCB) - Gaucher disease - A worldwide Phase 3 clinical program was initiated in 2007 and is ongoing. It is anticipated that this development program will support filing of velaglucerase alfa from H2 2009.
- Whilst a number of preclinical products are underway in early stage
development, Shire has discontinued the following projects: SPD491 (a pain
product), SPD493 (formerly known as Valrocemide), SPD500 (Tissue protective
cytoki
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