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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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Related biology technology :

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2. Shires ELAPRASE(R) (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
3. Shire Engages Palio
4. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
5. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
6. Shire Expands its Gastrointestinal Portfolio Through In-Licensing Celiac Disease Phase 2 Product From Alba Therapeutics Corporation
7. Alba Therapeutics Corporation and Shire plc Enter Into $325 Million ex-US, ex-Japan Licensing Agreement to Develop and Commercialize AT-1001
8. Shire plc: Board Changes
9. David Mott Appointed Non Executive Director at Shire
10. Correction: Shire plc: Third Quarter 2007 results date notification November 1, 2007
11. Shire Divests Non-Core Product Portfolio to Almirall
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