2005P-0322
CP 1
Volume 1

Citizen Petition

Attachment 1 - Rosenfeld RG, Rosenbloom AL, Guevara-Aguirre J. Growth hormone (GH) insensitivity due to primary GH receptor deficiency. Endocr. Rev. 1994 Jun; 15(3): 369-390 Published Material

Attachment 2 - Tercica, 10-K Annual Report, 6-7 (Mar. 24, 2005) (available at http://www.shareholder.com/Common/Edgar/1262175/1193125-05-59908/05-00.pdf

Attachment 3 - Tercica Press Release, "Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-I Deficiency," (Feb. 28, 2005) (available at http://investor.tercica.com/releases.cfm Published Material

Attachment 4 - Tercica, Press Release, "FDA Accepts Tercica’s Increlex New Drug Application With Priority Review for the Treatment of Short Stature" (May 2, 2005) (available at http://investor.tercica.com/releases.cfm) Published Material

Attachment 5 - Ratner ML. Tercica: growing small. Start-Up: Windhover’s Review of Emerging Medical Ventures. 2004 Dec; 9(11): 13-18 Published Material

Attachment 6 - Firth SM, McDougall F, McLachlan AJ, Baxter RC. Impaired blockade of insulin-like growth factor I (IGF-I)-induced hypoglycemia by IGF binding protein-3 analog with reduced ternary complex-forming ability. Endocrinology 2002 May; 143(5): 1669-76 Published Material

Attachment 7 - Guler HP, Zapf J, Froesch ER. Short-term metabolic effects of recombinant human insulin-like growth factor I in healthy adults. N Engl J Med. 1987 Jul 16; 317(3): 137-40 Published Material

Attachment 8 - F-D-C Reports, Inc., "The Pink Sheet" 65(51): 20 (Dec. 22, 2003). Symlin "Approvable" Letter Will Be Addressed By Ongoing Trials, Amylin Says Published Material

Attachment 9 - Underwood L, Chernausek SD, Kuntze J, Frane J, Bright GM. Efficacy of long-term treatrnent with recombinant human IGF-I (rhIGF-I) of children with GH insensitivity [abstract no. P3-451]. Presented at: The Endocrine Society’s 86th Annual Meeting, New Orleans, June 2004

Attachment 10 - Chernausek, SD, Underwood L, Kuntze J, Frane J, Bright GM. Safety of recombinant human IGF-I in the treatment of children with IGF-I deficiency due to GH insensitivity: 231 treatment-years of experience [poster]. Presented at: The Endocrine Society’s 86th Annual Meeting, New Orleans, June 2004

Attachment 11 - Backeljauw PF, Underwood LE; GHIS Collaborative Group. Prolonged treatment with recombinant insulin-like growth factor-I in children with growth hormone insensitivity syndrome- a clinical research center study. J Clin Endocrinol Metab. 1996 Apr; 81(9): 3312-17 Published Material

Attachment 12 - Underwood LE, Backeljauw P, Duncan V, GHIS Collaborative Group. Effects of insulin-like growth factor I treatment on statural growth, body composition and phenotype of children with growth hormone insensitivity syndrome. Acta Paediatr Suppl. 1999; 428: 182-184 Published Material

Attachment 13 - Backeljauw PF, Underwood LE, GHIS Collaborative Group. Therapy for 6.5-7.5 years with
recombinant insulin-like growth factor I in children with growth hormone insensitivity syndrome: a clinical research center study. J Clin Endocrinol Metab. 2001;86(4): 1504-1510 Published Material

Attachment 14 - Clark R, Frane J. and Bright, G. Long-term Therapy with rhIGF-I: No evidence of Neutralizing Antibodies [poster P1-493]. Presented at: The Endocrine Society’s 87th Annual Meeting, San Diego, June 2005

Attachment 15 - Ranke MB, Savage MO, Chatelain PG, Preece MA, Rosenfeld RG, Blum WF, et al. Insulin-like growth factor I improves height in growth hormone insensitivity: two years’ results. Horm Res. 1995; 44(6): 253-264 Published Material

Attachment 16 - Guevara-Aguirre J., et al. A randomized, double blind, placebo-controlled trial on safety and efficacy of recombinant human insulin-like growth factor-I in children with growth hormone receptor deficiency. J Clin Endocrinol Metab. 1995 Apr; 80(4): 1393-8 Published Material

Attachment 17 - Guevara-Aguirre J, Rosenbloom AL, Vasconez O, Martinez V, Gargosky SE, Allen L, et al. Two-year treatment of growth hormone (GH) receptor deficiency with recombinant insulin-like growth factor I in 22 children: comparison of two dosage levels and to GH-treated GH deficiency. J Clin Endocrinol Metab. 1997 Feb; 82(2): 629-633 Published Material

Attachment 18 - Malozowski S, Tanner LA, Wysowski D, Fleming GA. Growth hormone, insulin-like growth factor I, and benign intracranial hypertension [letter]. N Engl J Med. 1993; 329(9): 665-666 Published Material

Attachment 19 - Malozowski S, Stadel B. Risks and benefits of insulin-like growth factor [letter]. Ann Int Med. 1994; 121(7): 549-550 Published Material

Attachment 20 - The DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329: 977-86 Published Material

Attachment 21 - The DCCT Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes 1997; 46: 271-86 Published Material

Attachment 22 - Genuth S. Exogenous insulin administration and cardiovascular risk in non-insulin-dependent and insulin-dependent diabetes mellitus. Ann Intern Med. 1996; 124: 104-9 Published Material

Attachment 23 - Tercica, S-1 Registration Statement, at 8 (Sept. 12, 2003) (available at
http://www.sec.gov/Archives/edgar/data/1262175/000119312503048598/dsl.htm