Cangene has received an approvable letter from the United States Food and Drug Administration (FDA) for Accretropin, Cangene's recombinant human growth hormone (rhGH). The drug's indication is treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome.
Accretropin was submitted under section 505(b) of the United States Federal Food, Drug and Cosmetic Act last summer. In its action letter, the FDA requested additional support data regarding manufacturing processes. As fulfilling this requirement does not involve further clinical trials, Cangene anticipates being able to respond quickly. Cangene has three drugs already approved by the FDA, but this is the first of its recombinant products to be filed in the United States. Accretropin was developed under a research and development agreement with the Apotex Group, Cangene's majority shareholder.
"This is a significant milestone and we intend to continue working closely with the FDA to complete the process as quickly as possible," said Dr. John Langstaff, Cangene's president and CEO. "While Cangene may be better known for its hyperimmune products, we have developed considerable expertise in the production of recombinant protein therapeutics and consider this side of our business to have significant future potential for the Company".
Cangene's rhGH is identical in sequence to naturally produced human growth hormone of pituitary origin and is manufactured in the Company's biotechnology manufacturing facility in Winnipeg, Manitoba. Natural human growth hormone is a protein produced by the pituitary gland that acts on the long bones of the body until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature. A number of approved human growth hormone products made by other companies compete for a large international market.
Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.
Cangene is one of Canada's largest and earliest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and in Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins.