PROLOR Shares Higher as EMA, EC Grant Orphan Drug Status for HGH-CTP
PROLOR Biotech, Inc. (NYSE: PBTH) shares are up 3.4 percent today following news 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.
"By reducing the dosing frequency to just one injection every week, our longer-acting human growth hormone has the potential to improve the lives of the many individuals with growth hormone deficiency," said Dr. Abraham Havron, CEO of PROLOR. "We believe this European orphan drug designation further confirms that hGH-CTP may provide significant benefits to patients. We also believe that the designation will prevent any other long-acting recombinant growth hormone from being marketed in Europe for 10 years after the launch of hGH-CTP, expanding the breadth of the marketing exclusivity we have already received from our U.S. orphan drug designation."
PROLOR's hGH-CTP received orphan drug designation in the U.S. in October, 2010. The U.S. Orphan Drug Act of 1983 provides for seven years of market exclusivity, reductions in regulatory fees, certain tax credits and additional regulatory support.
Medicinal products intended for rare diseases in the European Union can receive an orphan drug designation based on defined criteria. These include relatively low prevalence, the fact that the disease is life-threatening or for a serious and chronic condition, and the lack of a satisfactory method of prevention or treatment of the condition. If a method currently exists, the orphan candidate must be of significant benefit to those affected by the condition.
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