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PATH -PROLOR Biotech's longer-acting human growth hormone receives orphan drug designation in Europe (PBTH) 4.99 : Co announced that the European Commission and the European Medicines Agency (EMA) have granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone in development for the treatment of growth hormone deficiency. PROLOR will receive 10 years of marketing exclusivity in Europe for hGH-CTP, beginning at product launch. This is the first time a growth hormone product has received orphan drug designation in Europe.

"In Phase II studies in growth hormone-deficient adults, hGH-CTP was safe and well tolerated, and it demonstrated the potential to be administered once-weekly, replacing seven daily injections of currently marketed human growth hormone. These results enabled PROLOR to initiate a Phase II trial in children with growth hormone deficiency and to proceed with plans for a Phase III trial in growth hormone-deficient adults, which is scheduled to begin later this year."