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FDA approves additional dosage strengths of Vyvanse

PHILADELPHIA January 3, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for three additional dosage strengths for the attention deficit hyperactivity disorder (ADHD) treatment, VYVANSE™ (lisdexamfetamine dimesylate). Shire expects the three additional dosage strengths of 20 mg, 40 mg and 60 mg will be available in retail pharmacies in the second quarter of 2008 to supplement the existing 30 mg, 50 mg and 70 mg dosage strengths currently available in pharmacies throughout the country.

Shire is pleased that physicians will soon have the benefit of a wider range of VYVANSE dosage strengths which they can prescribe to help manage the ADHD symptoms of their patients, said Matt Emmens, Chief Executive Officer of Shire Pharmaceuticals. In its first six months of availability, more than 500,000 VYVANSE prescriptions have been dispensed, indicating that physicians see VYVANSE as an effective treatment option for their patients.

Dose titration, the process of incrementally increasing or decreasing the dose of a medication, is a widely used method in clinical practice to help achieve optimal efficacy and tolerability for each patient. The option of having dosage strengths with smaller increments allows for a more gradual titration of medication and may help the physician tailor the treatment for each individual patient.

Shire has also experienced early success with managed care coverage for VYVANSE, which is now preferred on three of the five largest national plans. According to available national data, more than 85 percent of lives in the United States are covered for VYVANSE in Tier 3 or better, added Emmens. We are optimistic that the formulary coverage for VYVANSE will continue to improve as we move into 2008.

VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the FDA.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.


Contact: Jacelyn Seng
Porter Novelli

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