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 EuropeanMedicines Agency (EMA) have granted orphan drug designation to hGH-CTP,PROLOR's longer-acting version of human growth hormone in development for thetreatment of growth hormone deficiency.  PROLOR will receive 10 years ofmarketing exclusivity in Europe for hGH-CTP, beginning at product launch. This is the first time a growth hormone product has received orphan drugdesignation in Europe.In Phase II studies in growth hormone-deficient adults, hGH-CTP was safe andwell tolerated, and it demonstrated the potential to be administeredonce-weekly, replacing seven daily injections of currently marketed humangrowth hormone.  These results enabled PROLOR to initiate a Phase II trial inchildren with growth hormone deficiency and to proceed with plans for a PhaseIII trial in growth hormone-deficient adults, which is scheduled to beginlater this year."By reducing the dosing frequency to just one injection every week, ourlonger-acting human growth hormone has the potential to improve the lives ofthe many individuals with growth hormone deficiency," said Dr. Abraham Havron,CEO of PROLOR.  "We believe this European orphan drug designation furtherconfirms that hGH-CTP may provide significant benefits to patients.  We alsobelieve that the designation will prevent any other long-acting recombinantgrowth hormone from being marketed in Europe for 10 years after the launch ofhGH-CTP, expanding the breadth of the marketing exclusivity we have alreadyreceived 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 marketexclusivity, reductions in regulatory fees, certain tax credits and additionalregulatory support.Medicinal products intended for rare diseases in the European Union canreceive an orphan drug designation based on defined criteria.  These includerelatively low prevalence, the fact that the disease is life-threatening orfor a serious and chronic condition, and the lack of a satisfactory method ofprevention or treatment of the condition.  If a method currently exists, theorphan candidate must be of significant benefit to those affected by thecondition.