PROLOR Biotech, Inc. 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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