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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

eived orphan drug designation by the EMEA, which may provide it with up to ten years market exclusivity in the EU; and

- AT2220 for Pompe disease is currently in Phase 1 clinical trials.

- SPD550 (Larazotide Aceotate) for Gastro Intestinal ("GI") disorders - In December 2007 Shire licensed rights to SPD550 (also known as AT-1001), in markets outside of the US and Japan, from Alba Therapeutics Corporation ("Alba"). SPD550 is Alba's lead inhibitor of barrier dysfunction in various GI disorders and is currently in Phase 2 development for the treatment of Celiac disease.

- SPD487 (Amphetamine transdermal system ("ATS")) - ADHD - In June 2007 Shire acquired exclusive development rights to ATS following completion of early development work by Noven.

During 2007 Shire has made $155.9 million of up-front payments for the in-licensing of the above products comprising $75.0 million to Renovo, $50.0 million to Amicus, $25.0 million to Alba and $5.9 million to Noven. Shire also made a $50 million equity investment in Renovo Group plc.

Existing pipeline developments:

- VYVANSE for ADHD in adult patients

- In September 2007, the FDA accepted the filing of a supplemental New Drug Application for VYVANSE for the treatment of ADHD in adult patients. The Prescriptions Drug User Fee Act ("PDUFA") action date is April 28, 2008.

- On October 25, 2007 Shire released results from the Phase 3 clinical trials in adults. In this double-blind, placebo-controlled, four-week study with dose escalation in 414 adults aged 18 to 55 years, treatment with VYVANSE at all doses studied (30mg, 50mg, 70mg) was significantly more effective than placebo.

- Adults represent the largest and fastest growing segment of the ADHD market with a total of 9.9 million patients, of which 7.5 million are untreated.

- DAYTRANA - ADHD - Regulatory submissions were filed for approval of the product with Health Canada on November 29, 2007 and with the
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SOURCE Shire plc
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5. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
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