Launch Of Ipsen's Decapeptyl 6-Month Formulation (LP 22.5 Mg) In France For The Treatment Of Advanced Or Metastatic Hormone-Dependent Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Cancer / Oncology;  Urology / Nephrology
Article Date: 04 Feb 2010 - 13:00 PDT

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Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announce the launch by Ipsen in France of Decapeptyl® LP 22.5 mg 6-month sustained-release formulation for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. Other launches are planned shortly, notably in Germany and Portugal.

The marketing authorization (MA) to this 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate1 22.5 mg) was granted on 10 November 2009 by the French regulatory authorities (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) for the treatment of locally advanced and metastatic hormone-dependent prostate cancer. France was the first country to approve Decapeptyl® LP 22.5 mg in the context of a Decentralized Procedure in Europe. The reimbursement rate by Social Security and price setting decision have been published in the Journal Officiel of 3 February 2010, i.e. less than three months after MA was granted.

Decapeptyl® LP 22.5 mg is the new sustained-release 6-month formulation of a gonatropin- releasing hormone (GnRH) agonist analogue developed by Debiopharm Group. Debiopharm has licensed the marketing rights to Ipsen for all territories where Ipsen currently commercializes triptorelin.

On 13 October 2009, 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 national line extensions to the existing Decapeptyl®'s ones.

1 triptorelin embonate (INN) = triptorelin pamoate (USAN)

About Decapeptyl®

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl® is available in 1- and 3-month sustained-release formulations, as well as a daily formulation. Debiopharm developed and registered 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, uterine fibroids, precocious puberty, and female infertility as part of in-vitro fertilisation programs.

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 (defined as ≤ 1.735nmol/L or 50 ng/dL) 28 days after the first injection, and 93.0% of the patients maintained castrate levels of testosterone from week 8 to 48. Furthermore, at months 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 and safety 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.

Source
Ipsen
Debiopharm Group

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