Human Growth Hormone (hGH) is a licensed therapeutic for growth hormone deficient disorders in children such as short stature, Turner’s Syndrome and chronic renal insufficiency. In many countries the drug is also approved for adult growth hormone deficiency. The estimated global market for this product is USD 1.7 billion.
Growth hormone is produced in the pituitary gland of all animals throughout life and is released in multiple daily pulses. Levels of production vary depending on the individual and seasonal conditions, with a marked decrease in natural levels seen in aging animals.
Growth hormone acts on a multitude of different cell types, as evidenced by current documentation of over 450 actions of GH involving at least 45 different tissue types. GH exerts actions directly on target tissues and also indirectly through stimulation of release of Insulin-like Growth Factor (IGF-1).
The effects of growth hormone and IGF-1 include promotion of long bone growth, promotion of normal sex organ development through puberty, regulation of metabolism, stimulation of tissue growth and repair, anabolic /anti-catabolic effect via improved nitrogen retention, modulation of bone mineral density and metabolism throughout life, proliferation of some cell types of the immune system, appetite stimulation and breakdown of fat (lipolysis).
BresaGen has developed considerable expertise in the manufacture of human Growth Hormone (hGH) that allows the company to cost-effectively produce commercial quantities of the protein. The company strategy is initially to provide the drug as an Active Pharmaceutical Ingredient (API) for commercialisation in collaboration with pharmaceutical company partners.