Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turne... ( Treatment with Norditropin increases...)

Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome

Date:9/21/2007

Treatment with Norditropin increases gain in height for girls with Turner

syndrome

PRINCETON, N.J., Sept. 21 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that Norditropin(R) (somatropin [rDNA origin] injection) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of children with short stature associated with Turner syndrome. Turner syndrome is a rare chromosomal condition caused by complete or partial absence of the second sex chromosome (X chromosome) in females. This occurs in approximately 1 in 2,500 live female births, and in as many as 10 percent of all miscarriages worldwide. Short stature is the most common feature associated with Turner syndrome affecting the majority of patients (90 - 100 percent depending on the chromosomal abnormalities).

"Treatment of short stature in girls with Turner syndrome is the second new indication granted this summer for Norditropin, which recently received an approval to treat children with short stature associated with Noonan syndrome," said Martin Soeters, president of Novo Nordisk Inc. "Novo Nordisk is committed to our biopharmaceutical business unit, and we will continue to conduct research in rare disorders where there are currently treatment gaps."

This FDA approval signifies advancement in dosing capabilities, giving physicians the option of dosing at higher than existing treatment options. Results from a pivotal clinical trial illustrated that treatment with Norditropin at the higher dosing level of .067 mg/kg/day resulted in 80 percent of Turner syndrome patients reaching a normal adult height compared to only 53 percent at a lower dosing level.

"I know first hand from my practice that short stature can be a social and self image concern for girls with Turner syndrome," said Judith Ross, M.D., Professor, Department of Pediatrics at Thomas Jefferson University, Philadelphia. "Clinical data for Norditropin in girls
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