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FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Date:4/23/2008

esults could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGFb3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.

1. Adler L et al. Efficacy and Safety of Lisdexamfetamine Dimesylate in

Adults with Attention Deficit Hyperactvity Disorder. Paper presented at:

American Academy of Child and Adolescent Psychiatry Annual Meeting;

October 25, 2007; Boston, MA.

2. IMS National Prescription Audit (NPA), March 2008.

3. Biederman J, Hodgkins P, Krishnan S, Findling RL. Efficacy and

tolerability of lisdexamfetamine (NRP104) in children with

attention-deficit/hyperactivity disorder (ADHD): A phase 3, randomized,

multi-center, randomized, double-blind, forced-dose, parallel group

study. Clinical Therapeutics. 2007; 29:450-463. [Note to MLR: Please

refer to Table III.]

4. Vyvanse [package insert]. Wayne, PA: Shire Pharmaceuticals Inc; 2006.

5. DuPaul GJ. Pa
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SOURCE Shire PLC
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