• Efficacy and safety results from phase III study of triptorelin pamoate 11.25 mg administered subcutaneous ly are both clinically and statistically significant;
• These results are consistent with the known efficacy and safety profile of Decapeptyl ® when administered intramuscularly.
Paris (France), 7 February 2014 Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the phase III clinical trial evaluating Decapeptyl® (triptorelin pamoate) 11.25 mg administered subcutaneously in patients with locally advanced or metastatic prostate cancer has met its primary endpoints. The full study results will be presented this year during a medical congress. Based on these results, Ipsen intends to apply for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25 mg.
Claude Bertrand, Executive Vice-President, Research & Development and Chief Scientific Officer of Ipsen stated: “The efficacy and safety of triptorelin pamoate 11.25 mg in the treatment of patients with prostate cancer is well-established. The availability of an efficacious and safe subcutaneous formulation offers a more convenient and suitable way of administrating triptorelin pamoate to patients on oral anticoagulants or cachectic patients for whom intramuscular administration is not recommended. Through its willingness to offer a wider and more adapted product range, Ipsen reaffirms its positioning as a patient-centric organization”.
About the clinical study
The single arm, open label, phase III study evaluated the efficacy, safety and local tolerability of a 3-month triptorelin pamoate (11.25 mg) administered subcutaneously in patients with locally advanced or metastatic prostate cancer. The study co-primary end points were: the proportion of patients castrated at Day 29, and the proportion of patients with castration maintained at Day 183. The castration is defined by testosterone levels of < 50 ng/dL. The study was performed in 5 European countries (Latvia, Bulgaria, Romania, Poland and France) with a target recruitment of 120 patients.
About Decapeptyl® (triptorelin pamoate)
Decapeptyl® is a peptide formulation for injection to be used mainly in the treatment of locally advanced or metastatic prostate cancer. Additional indications developed subsequently include the treatment of uterine fibroids (a benign tumour of muscle tissues in the uterus), endometriosis (proliferation of endometrial tissue, the mucous membrane that lines the uterine wall outside the reproductive tract) after surgery or when surgery is not deemed appropriate, as well as early onset puberty and female infertility (in vitro fertilisation).
The active substance in Decapeptyl® is triptorelin pamoate, a decapeptide analogue of GnRH (Gonadotrophin Releasing Hormone), a hormone secreted by the hypothalamus, which initially stimulates the release of pituitary gonadotrophins (hormones produced by the pituitary gland), which in turn control hormonal secretions by the testicules and ovaries. Administration of triptorelin results in the suppression of the GnRH activity leading to hormonal castration in men and menopausal phase in women.
In 2013, this product generated sales of €298.6 million, representing around 24.4% of consolidated Group sales. The formulations of Decapeptyl® marketed by the Group include a daily formulation, one-month, three-month and six-month formulations. Ipsen is the first pharmaceutical company to have launched the three-month formulation in China.
Ipsen (ipsen.com) is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totaled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY.