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Ipsen and Debiopharm Group Announce That Decapeptyl(R)(triptorelin embonate) 6-month Successfully Completes the European Decentralised Procedure for the Treatment of Locally Advanced or Metastatic Prostate Cancer
Date:10/13/2009

to receiving a more convenient treatment every six months instead of every three months."

About Decapeptyl(R)

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl(R) is available in monthly or quarterly sustained-release formulations, as well as a daily formulation. Debiopharm developed and submitted the 1- and 3-month sustained release formulations of triptorelin embonate in Europe and the U.S. The active substance in Decapeptyl(R) is triptorelin, a decapeptide analogue of GnRH (Gonadotropin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotropins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testes and ovaries.

The product is now marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, and uterine fibroids.

The marketing authorisation application for the 6-month-formulation was submitted to the registration authorities of nine European countries in September 2008, in accordance with the decentralised procedure. It was supported by data from a phase III study on the efficacy, pharmacokinetics and safety of two consecutive injections of triptorelin 6-month-formulation in 120 patients with advanced prostate cancer. The results showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection, and 93.0% of the patients maintained castrate levels of testosterone (defined as less than or equal to 1.735nmol/L or 50ng/dL) from week 8 to 48. Furthermore, at month 6 and 12 98.3% of the patients were castrated. Overall the phase III data demonstrated that the treatment was well tolerated. The local tolerance of the product was very good with few patients (6.7%) experiencing local side effects, the majority of them being mild. T
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SOURCE Debiopharm Group
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