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Debiopharm Announces First Patient Enrolled in Phase III Study for the Rare Disease Central Precocious Puberty
Date:8/27/2012

on, which often results in reduced adult height and disproportioned body appearance due to premature fusion of the growth plates.

Reliable epidemiological data on CPP worldwide are not available. The condition occurs in about 1 out of every 5,000 to 10,000 children (leading to an estimated prevalence of 10,000 to 20,000 children in the USA). These numbers show that CPP is a rare disease. Central precocious puberty is more common in girls than in boys, with a female : male ratio estimated to be between 3:1 and 23:1.

About Triptorelin

Triptorelin is a synthetic decapeptide agonist analogue that was first registered in France in 1986 and is currently marketed in more than 80 countries in various indications including advanced prostate cancer and CPP. Chronic administration of triptorelin causes down regulation of the pituitary GnRH receptors and suppresses gonadotropin (LH and FSH) secretion and finally the release of gonadal sex-hormones. Triptorelin shows a safety profile similar to other GnRH agonists. Except for injection site reactions or rare immunoallergic reactions, the side effects of triptorelin are mostly due to the initial increase in testosterone/oestrogen levels (e.g. vaginal bleeding in girls) followed by almost complete suppression of testosterone/oestrogen (e.g. hot flushes and headaches).

However, numerous published studies over more than 25 years involving large series of children (≥ 20 studies) around the world have reported efficacy and safety results with different triptorelin acetate and pamoate (embonate) 1- and 3-month formulations consistent with those of other approved GnRH agonists in this indication. None of these studies has revealed any safety issues.

About Debiopharm Group™

Debiopharm Group™ (Debiopharm) is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses, develo
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