Ipsen's Decapeptyl(R) 6-Month Formulation Receives Marketing Authorization For The Treatment Of Locally Advanced Or Metastatic Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 30 Nov 2009 - 2:00 PST

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Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical Group announces that the French regulatory authorities (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) have granted the marketing authorization to the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate1 22.5 mg) for the treatment of locally advanced and metastatic prostate cancer. The launch of the 6-month formulation of Decapeptyl® in France by Ipsen should take place during the first semester of 2010.

"Ipsen is pleased that the new 6-month formulation of Decapeptyl® will soon be available for patients in France suffering from prostate cancer. Its improved convenience comes with a consistent and similar efficacy and tolerance to the already established Decapeptyl®'s 1 and 3-month Decapeptyl® formulations," said Etienne de Blois, Deputy General Manager, France Operations, Ipsen.

Triptorelin embonate 22.5 mg is a new 6-month-formulation of a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer, developed by Debiopharm Group. Debiopharm has licensed the marketing rights to Ipsen for all territories where Ipsen currently commercializes triptorelin.

Last 13 October, Ipsen and Debiopharm Group announced the successful completion of the European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands while for other European countries (Portugal, United Kingdom, Ireland, Italy, Romania and Lithuania), the marketing authorisation applications were filed as a national line extension to the existing Decapeptyl®'s ones. France is the first country to approve Decapeptyl® 6-month in the context of the Decentralized procedure in Europe.

About Decapeptyl®

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl® 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® 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 ≤ 1.735nmol/L or 50 ng/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. These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month-formulations of triptorelin.

Debiopharm will manufacture the 6-month formulation at Debio R.P., its FDA-inspected production facility in Switzerland.

1 triptorelin pamoate is similar to triptorelin embonate

Source
Ipsen