EQUETRO

From Shire Pharmaceuticals Group plc:


13 Dec 2004 - Basingstoke, UK and Philadelphia, US 13 December 2004 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that the US Food & Drug Administration (FDA) has approved EQUETRO (extended-release carbamazepine capsules), previously known as SPD417, for the treatment of patients with Bipolar Disorder, ten months after submission.


Bipolar Disorder is one of the six leading mental disorders worldwide, according to the World Health Organization. Each year, it is estimated that more than 2 million American adults, about 1 percent of the population age 18 and older, are afflicted with Bipolar Disorder, also known as manic depression. Of the 750,000 currently diagnosed, about 650,000 are treated. The bipolar market in the United States is currently valued at about $1.9bn and is expected to grow to $2.4bn by 2007.


Bipolar Disorder is characterized by episodes of mania and depression, with periods of normal mood in between. The disorder can have devastating effects on an individual’s life, although proper diagnosis and earlier treatment can usually alter the course of the illness.


EQUETRO significantly reduces the manic symptoms in Bipolar patients. Additionally, in clinical trials, patients treated with the product demonstrated no clinically significant weight gain or increase in blood glucose levels, thereby creating an effective tolerability profile. The unique three-bead extended release delivery system of Equetro provides for convenient administration as well. Available in 100, 200 and 300mg dosage strengths, it is the only carbamazepine formulation proven effective for patients with Bipolar Disorder.


Pill Identification - EQUETRO (carbamazepine extended-release):


100 mg-Two-piece hard gelatin capsule yellow opaque cap with bluish green opaque body printed with SPD 417 on one end, SPD417 100 mg on the other in white ink


200 mg-Two-piece hard gelatin capsule yellow opaque cap with blue opaque body printed with SPD 417 on one end and SPD417 200 mg on the other in white ink


300 mg-Two-piece hard gelatin capsule yellow opaque cap with blue body printed with SPD 417 on one end and SPD417 300 mg on the other in white ink.


Updated 03-08-06