Date: 2016-01-11
Type of information: Commercialisation agreement
Compound: sustained release triptorelin pamoate 22.5 mg 6-month-formulation
Company: Debiopharm (Switzerland) Arbor Pharmaceuticals (USA - GA)
Therapeutic area: Rare diseases - Endocrine diseases - Hormonal diseases
Type agreement: distribution commercialisation
Action mechanism: peptide. 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).
Disease: central precocious puberty (CPP)
Details: * On January 11, 2016, Debiopharm International and Arbor Pharmaceuticals jointly announce the execution of a distribution agreement for the commercialization and promotion of triptorelin 22.5 mg in the United States for central precocious puberty (CPP). Under the terms of the agreement, Arbor acquires exclusive commercial rights for triptorelin 22.5 mg in the U.S., for the CPP indication. The product will be exported from Debiopharm Research and Manufacturing SA to Arbor. Once approved, triptorelin 22.5 mg will be made available primarily to pediatricians and pediatric endocrinologists.
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