Norditropin (Somatropin)

Caralee

David Helen Group 14

Huma

The disease: Growth hurmone definiency

Human growth hormone (hGH) is essential for a normal growth. The pituitary gland receives growth hormone releasing hormone (GHRH) from hyphathalamus to produce hGH. This stimulates the liver to produce insulin-like growth factor-1(IGF-1) which together with hGH can increase cells in bones, muscles and other organs and tissues to grow. GHD is a condition in which the pituitary gland is not capable of producing the enough amount of growth hormone for normal bone and muscle growth. GHD can be present from birth of the child, or it can occur at any time during infancy or later in childhood.

Without treatment it can lead to lack of energy and lethargy and failure in obtaining a normal adult body shape and facial features. And when bones will not grow in length or strength this leads to weak bones (osteoporosis) during adult life.

Targeting and functionality

Norditropin is trademark for the drug known as Somatropin 191 aminoacid and 4 helixes Binded dimeric GH receptor growth Main effects: Tissue, skeletal, organ and cell growth Variated metabolisms: Carbohydrate Lipid Mineral Protein Also may present some negative effects

hGH production & clinical trials

Cloned hGH is constructed from human tissues Signal sequence for some amino acids is removed and replaced by synthetic amino acids The signal sequence is inserted into a plasmid The plasmid is transformed in E.coli The E.coli is taken for fermentation process The cells are separated from culture medium, filtered, purified, enzymatically converted from hGH to BhGH and purified again. Preclinical trials showed that BhGH (Norditropin) is safe to use.

Clinical trials showed that BhGH was efficient in promoting growth in children with growth retardation Norditropin is proven to have physical, chemical and biological profiles identical to those of hGH of pituitary origin

Patents

1988: Norditropin is introduced in Europe. 1994: Genentech claims that Novo Nordisk is infringing their patent on their hGH product. Alternating injunctions and appeals follow. Mar. 1997: Novo appeals Genentech's injunction, and is allowed to market Norditropin in the US. May 1997: Novo obtains its patent for hGH in the US. Oct. 1997: Novo sues four companies for patent infringement. 1998-2000: Novo reaches several out-of-court settlements with some of the companies. 2004: Novo's patent is ruled invalid due to inequitable conduct. This prevents Novo from barring other companies to market their hGH products in the US. 2005-2006: A biosimilar version of hGH is approved in the US and Europe.