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Tercica
Download PDF Members: Tercica, Inc., based in Brisbane, Calif., is a biopharmaceutical company committed to improving endocrine health. We are helping patients by partnering with the scientific and medical community to develop and commercialize therapeutics for growth and other endocrine disorders. In January 2006, less than four years after Tercica was founded, we commercially launched Increlex™ (mecasermin [rDNA origin] injection), or recombinant human Insulin-like Growth Factor-1 (rhIGF-1), in the United States. Increlex has received orphan drug exclusivity for its approved indication of the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone. In December 2005, we submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market Increlex in the European Union (EU) where the product has also been granted "orphan product" designation. We are currently conducting broad-scale Phase III clinical studies to evaluate the safety and efficacy of Increlex in children with Primary IGFD, which is a less extreme form of the product's approved severe Primary IGFD indication. Tercica licensed rights to develop, manufacture and commercialize Increlex from Genentech, Inc. Beyond Increlex, we are building a franchise of endocrinology products. In October 2006, we entered into a worldwide strategic collaboration agreement in endocrinology with Ipsen S.A. Under terms of the agreement, Ipsen granted Tercica exclusive rights to sell Somatuline® Autogel® (lanreotide) in the United States, subject to approval by the US Food and Drug Administration (FDA), and in Canada. Tercica granted Ipsen exclusive rights to sell Increlex in all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa, subject to approval by relevant regulatory authorities. Also through this collaboration agreement, the companies granted each other certain rights to their respective endocrinology pipelines. Somatuline® Autogel® is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue which inhibits the excess secretion of growth hormone and IGF-1. It is approved for the treatment of acromegaly and neuroendocrine tumors in over 50 countries worldwide. In July 2006, Health Canada approved Somatuline® Autogel® for the long-term treatment of patients with acromegaly due to pituitary tumors who have had inadequate response to or cannot be treated with surgery and/or radiotherapy and for the relief of symptoms associated with acromegaly. A New Drug Application was submitted to the FDA for the same indication on October 30, 2006.
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