TRCA Tercica (MM)

Tercica, Inc. (Nasdaq:TRCA) today announced that the Company has completed enrollment of all patients in its MS301 Phase IIIb trial, a study evaluating the efficacy and safety of the current formulation of Increlex� (mecasermin [rDNA origin] injection) administered in children with Primary IGFD. Increlex� is currently approved in the United States for the treatment of severe Primary IGFD. In this multi-center, open-label trial, children with Primary IGFD (height and IGF-1 levels at least two standard deviations below the mean for the child�s age and sex) are treated with Increlex� for one year. The primary endpoint for the trial is height velocity. Data from the MS301 trial is expected to be available in the second half of 2008. �We are pleased to have completed enrollment in MS301, which tests the safety and efficacy of administering Increlex for the treatment of short stature due to Primary IGFD. We plan to submit a supplemental NDA for this indication by year end 2008 if the data is positive,� said Dr. John A. Scarlett, Tercica's President and Chief Executive Officer. �A regulatory approval for Increlex in Primary IGFD will allow us to promote in a market that we estimate is approximately five times larger than the current indication of severe Primary IGFD,� added Dr. Scarlett. About Increlex� (mecasermin [rDNA origin] injection) The active ingredient of Increlex� is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone�s (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In Primary IGFD, children�s serum IGF-1 levels are low, despite the presence of a normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height. In children with this disorder, low IGF-1 levels are due to growth hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression. As such, these children cannot be expected to respond adequately to exogenous GH treatment. Some individuals may also have a range of metabolic disorders, including lipid abnormalities, decreased bone density, obesity and insulin resistance. Increlex� has been marketed in the United States by Tercica since early 2006 for the treatment of children with severe Primary IGFD. Severe Primary IGFD is defined by height and IGF-1 levels at least three standard deviations below the mean for age and sex, and presence of normal or elevated GH level. Exclusive rights to develop and commercialize Increlex� were licensed to Ipsen in October 2006 for all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa. About Tercica Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for short stature and other metabolic disorders. For further information on Tercica, please visit www.tercica.com. Safe Harbor Statement Except for the historical statements contained herein, this press release contains forward-looking statements concerning Tercica�s prospects and expectations, including without limitation, that Tercica: (A) expects data from the MS301 trial to be available in the second half of 2008; (B) plans to submit a supplemental NDA for this indication by year end 2008; and (C) estimates that the Primary IGFD market is approximately five times larger than the severe Primary IGFD market. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, risks and uncertainties related to the following: (i) if too many patients drop-out and/or there are difficulties in connection with data retrieval, the data may not be available in the second half of 2008, or at all; (ii) if the data do not demonstrate adequate efficacy and safety, Tercica may not submit a supplemental NDA for Primary IGFD by year-end 2008, or at all; (iii) the market for Increlex� in Primary IGFD may not be five times larger than the market for severe Primary IGFD; and (iv) the risks and uncertainties disclosed from time-to-time in reports filed by Tercica, including most recently Tercica's Form 10-Q for the quarter ending March 31, 2007 filed with the SEC on May 4, 2007. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.