Tercica Launches Increlex in the U.S.; Only Drug Approved for the Long-Term Treatment of Growth Failure Caused by Severe Primary IGFD.BRISBANE, Calif. -- Tercica, Inc. (Nasdaq:TRCA TRCA Toronto and Region Conservation Authority TRCA Trademark Remedy Clarification Act TRCA Terminal Radar Control Area (FAA) TRCA Teddy Roosevelt Conservation Alliance ) today announced the U.S. commercial launch of Increlex(TM) (mecasermin (rDNA origin) injection), the only recombinant human insulin-like growth factor-1 (rhIGF-1) replacement therapy indicated for the long-term treatment of growth failure in children with severe Primary IGFD. Tercica also announced that following its December 2005 submission for marketing approval in the EU, the company is preparing for a potential January 2007 launch of Increlex in Europe. Increlex, which is now available to patients throughout the U.S., represents the first major innovation in treating children with short stature since recombinant human growth hormone human growth hormone (HGH): see growth hormone. was approved 20 years ago. "With today's commercial launch of Increlex, physicians can now prescribe a safe and effective drug backed by 321 patient-years of clinical trial treatment experience in children affected by severe Primary IGFD," said John A. Scarlett, M.D., President and Chief Executive Officer of Tercica. "In addition to a label with safety and efficacy data representing up to 12.5 years of treatment in some children, Increlex is the most convenient rhIGF-1 replacement therapy product for parents and children to store, transport and administer." Increlex was generally well tolerated and no subjects withdrew from the clinical trials due to adverse events. The most common drug-related adverse events were hypoglycemia hypoglycemia: see diabetes. hypoglycemia Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction. , lipohypertrophy, and tonsillar tonsillar /ton·sil·lar/ (ton´si-lar) of or pertaining to a tonsil. ton·sil·lar or ton·sil·lar·y adj. Of or relating to a tonsil, especially the palatine tonsil. hypertrophy hypertrophy (hīpûr`trəfē), enlargement of a tissue or organ of the body resulting from an increase in the size of its cells. Such growth accompanies an increase in the functioning of the tissue. . Tercica's salesforce, which has been active in the field in the U.S. since October, has been calling on the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. endocrine community and discussing this newly understood cause of short stature and Increlex as a treatment option for children afflicted af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, with severe Primary IGFD. In addition, the company has fully implemented TerciCare, its reimbursement support program that will facilitate the exchange of information between patients, healthcare providers, and health insurance companies in order to assist patients in gaining appropriate reimbursement coverage for Increlex. TerciCare also serves as the portal to Tercica's Patient Assistance Program, which will support access to Increlex for patients who do not have adequate medical coverage. Tercica estimates that approximately 6,000 children in the U.S., and approximately the same number in the EU, are affected by severe Primary IGFD. The company plans to broaden the indicated use for Increlex in the U.S. and the EU with supplemental applications, pending positive results of ongoing clinical trials evaluating Increlex in children with Primary IGFD. Primary IGFD is characterized by height and IGF-1 levels that are two standard deviations below the mean, in spite of normal or elevated growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). levels. Tercica estimates that approximately 30,000 children in the U.S. are affected by Primary IGFD, which is also similar to the estimated EU market size. About IGF-1 and severe Primary IGFD The active ingredient of Increlex is identical to the natural hormone IGF-1, which the body normally produces in response to stimulation by GH. IGF-1 is the direct mediator of growth hormone's effect on statural growth and must be present in order for children's bones, cartilage and organs to grow normally. Without adequate IGF-1, children cannot achieve a height within the normal range. Children with severe Primary IGFD have a height that is three standard deviations or more below the mean, they are IGF-1 deficient but are not GH deficient and, because they are resistant to the effects of GH, they cannot be expected to respond adequately to approved doses of GH. Severe Primary IGFD can lead to a range of other metabolic disorders including lipid abnormalities, decreased bone density, obesity and insulin resistance Insulin Resistance Definition Insulin resistance is not a disease as such but rather a state or condition in which a person's body tissues have a lowered level of response to insulin, a hormone secreted by the pancreas that helps to regulate the level . About Tercica Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. The company's first product, Increlex(TM) (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the treatment of severe Primary IGFD. Increlex offers several convenience advantages, including a multi-dose vial good for 30 days after first use and simple refrigeration refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. requirements, making it easy for children and parents to store, transport, and administer. For further information on Tercica, please visit www.tercica.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Except for the historical statements contained herein, this press release contains forward-looking statements, including without limitation, the statements that Tercica: (1) is preparing for a potential January 2007 launch of Increlex in Europe; (2) believes that approximately 30,000 children in the U.S. and EU are affected by Primary IGFD and 6,000 children in the U.S. and EU are affected by severe Primary IGFD; and (3) plans to broaden the indicated use for Increlex in the U.S. and EU. 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 those risks and uncertainties disclosed from time to time in reports filed by Tercica with the SEC, most recently Tercica's Form 10-Q Form 10-Q See 10-Q. filed on November 4, 2005, and Form 8-Ks filed on December 14 and December 15, 2005, and other factors regarding: (1), Increlex may not be approved by the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ; (2), there may be fewer children than Tercica estimates; and (3) results from the ongoing clinical trials may not be sufficient to obtain marketing approval for a broader indication. These statements are based on information as the date of this press release. Tercica assumes no obligation to update any forward-looking statements. |
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