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Human Growth Hormone
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History of HGH

Page 4
The History of HGH
They called their new synthetic HGH product "Humatrope". Eli Lily also sought protection for their new HGH product by the Orphan Drug Act.

A court battle followed between Genentech and Eli Lily. Genentech agreed to license its process patents to Eli Lily for about $145 million. After the battle the decision was that both companies would be able to produce and distribute their drug and all other companies would be shut out of the US market. Once the court battle between Genentech and Eli Lily had ended each company began to distribute their products for use in children.

Although it was not in writing, these companies and the FDA seemed to have an understanding that the HGH products would only be used in children to treat growth hormone deficiency. Both companies were allowed exclusive rights to the market for seven years under the Orphan Drug Act. A prescription at that time could cost over $45,000 per year to treat an HGH - Human Growth Hormone deficient child.

With one year's supply of their HGH product costing each patient $14,000 to $30,000 per year, Genentech and Eli Lily soon made about $175 million just by selling their HGH products to children with growth hormone deficiency. This was an enormous amount of money but it was soon realized that the real potential of HGH lay in what it could do to combat aging and how it could help various health conditions in adults.

In 1995 the Orphan Drug exclusivity for marketing ran out, immediately several European companies looked to enter the US HGH market. Novo Nordisk, a Scandinavian biotechnological company, and an Israeli company named Biotechnology General were making recombinant HGH using a process similar to Genentech's process. Both companies maintained that their process was significantly different to the process of Genentech.

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