Prolor Biotech, Inc. (PBTH) recently announced that its longer-acting version of the human growth hormone, hGH-CTP, has been granted orphan drug status by the US Food and Drug Administration (FDA).
This drug, currently undergoing mid-stage studies, is being developed to treat adults and children with deficiency in growth hormone. The candidate is being evaluated as a weekly or bi-monthly injectable therapy as opposed to the multiple injections per week needed by current treatments.
The randomized, open-label, dose-finding mid-stage study, expected to be completed next year, is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the injectable candidate (either weekly or bimonthly). We remind investors that the candidate fared well in an early-stage study which showed that hGH-CTP could prove to be effective if injected on a bi-monthly basis.
The orphan drug status is granted by the US regulatory agency to drugs developed for treating a rare disease which affects less than 200,000 people in the US. The designation grants seven years of marketing exclusivity in the US to the company developing the drug in addition to tax benefits on its development costs.
Consequently, the orphan drug status granted to hGH-CTP will aid its development and provide a wider choice to patients suffering from the rare disease. We believe that the successful development of the candidate would be welcomed by growth hormone deficient individuals since Prolor Biotech’s treatment significantly reduces the frequency of injections required with current therapies. Moreover, hGH-CTP will target the highly lucrative $3 billion human growth hormone market.
Currently, we have a long-term Neutral stance on Prolor Biotech, which is supported by our Zacks# 3 Rank (short-term ‘Hold’ recommendation).
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