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Human Growth Hormone: Products
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Norditropin® SimpleXx™ (somatropin [rDNA origin] for injection) A liquid formulation of human growth hormone delivered in a pen system, NordiPen™, designed to make daily injections more convenient. This product is bioequivalent to Norditropin® but does not require reconstitution prior to use. Product is marketed in Europe and Japan under the Norditropin SimpleXx trademark. Note: Approved in U.S. (see Norditropin® cartridge); ... information regarding whether or not it will carry the SimpleXx trademark here awaits response to inquiry sent to the manufacturer.Note: The product name is also shown as Simplexx™ in some press releases at the manufacturer's web site; however, according to a Novo Nordisk representative, the trademark does contain the capital X as written above. --> Mfg: Novo Nordisk. Source: PR Newswire - 03/23/99, 06/21/00.
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States of both growth hormone deficiency and excess provide very visible testaments to the role of this hormone in normal physiology. Such disorders can reflect lesions in either the hypothalamus, the pituitary or in target cells. A deficiency state can result not only from a deficiency in production of the hormone, but in the target cell's response to the hormone.
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The first successful pharmaceutical products employing genetically engineered organisms were protein drugs like human insulin (1982) and human growth hormone (1987). These drugs are manufactured in cell cultures employing genetically modified bacteria in bioreactors. However, bacteria and other micro-organisms cannot produce the more complex human proteins. For this, higher organisms like mammals are needed.
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Ambrx selected human growth hormone (hGH) to demonstrate the power of its ReCODE™ protein engineering platform. Growth hormone represents a significant, expanding market: worldwide sales were nearly $2.0 billion in 2004 and are estimated to be growing at 10-15% annually. Ambrx’s hGH product with optimized pharmacology and preserved potency represents a significant commercial opportunity.
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