FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and A...(looking statements involve a numberof ri...),Health

Date:7/28/2009

looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

1. Biederman J, Melmed R, Patel A, et al. A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2008;121(1):e73-e84.

2. Sallee F, McGough J, Wigal T, et al. Guanfacine extended release in children and adolescents with ADHD: a placebo-controlled trial. J Am Acad Child and Adolesc Psychiatry. 2009;48(2):1-11.

3. Connor D, Spencer T, Kratochvil C, et al. Effects of guanfacine extended release on secondary measures in children with attention-deficit/hyperactivity disorder and oppositional symptoms. Presented at the American Psychiatric Association Annual Meeting; May 18, 2009; San Francisco, CA.

4. Arnsten AF, Scahill L, Findling
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