Prolor will receive 10 years of marketing exclusivity in Europe for hGH-CTP.
Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) today announced that the European Commission and the European Medicines Agency (EMA) have granted orphan drug designation to hGH-CTP, the company's longer-acting version of human growth hormone for the treatment of growth hormone deficiency. The approval comes two years after the US Food and Drug Administration (FDA) granted the hormone orphan drug status in October 2010. This is the first time a growth hormone product has received orphan drug designation in Europe.
Prolor will receive 10 years of marketing exclusivity in Europe for hGH-CTP, which is still under development, beginning at product launch. A Phase II clinical trial in growth hormone-deficient adults found that hGH-CTP was safe and well tolerated, and that the drug's weekly dosage could replace the seven daily injections of currently marketed human growth hormone. On the basis of these results, the company began Phase II clinical trial in children with growth hormone deficiency and plans to begin a Phase III trial in adults 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 Prolor CEO Dr. Abraham Havron. "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."
Published by Globes [online], Israel business news - www.globes-online.com - on February 13, 2013
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