Ipsen Announces Positive Results from Phase III Clinical Study of Decapeptyl® (triptorelin pamoate) 11.25 mg Administered by Subcutaneous Route to Prostate Cancer Patients

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced positive results from the phase III study of triptorelin pamoate 11.25 mg (Decapeptyl® 3 months) administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology (EAU) 14th Central European Meeting in Cracow, Poland (10-12 October 2014).

The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg (Decapeptyl® 3 months) formulation when administered by the subcutaneous route in men with locally advanced or metastatic prostate cancer. This objective was met with castration levels of testosterone achieved in 97.6% [95% CI: 93.2-99.5] of men at week 4 and castration maintained in 96.6% of these men [95% CI: 91.6-99.1] at week 26.

Mean testosterone levels decreased to 18.4 ng/dl and 10.2 ng/dl at week 4 and week 8, respectively, and remained within this range until the end of the study. Median time to achieve castration was 22 days. For more than 90% of the patients, the level of testosterone was maintained below 20 ng/dl from week 8 up to the end of the trial.

Median Prostate Specific Antigen (PSA) levels were reduced by 64.2% and 96.0% at week 4 and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week 8 until the end of the study.

The efficacy results and safety profile of triptorelin pamoate 11.25 mg administered by the subcutaneous route are consistent with the known efficacy and safety profile of triptorelin administered by the intramuscular route.

Based on these results, Ipsen has applied 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: “These results provide further evidence to the efficacy and safety of Decapeptyl® in the treatment of patients with prostate cancer. The subcutaneous route widens the options for the administration of Decapeptyl® and may be offered to patients for whom intramuscular administration is not recommended. Ipsen is pleased to reaffirm its positioning as a patient-centric organization.”

About the study
This study is a multicentre, open-label, single-arm study of triptorelin pamoate 11.25 mg given by the subcutaneous route twice (at baseline and 13 weeks later), in which patients from 14 centres were monitored for 26 weeks between October 2012 and October 2013. The co-primary endpoints were the proportion of patients with a castration level of serum testosterone (<50 ng/dl) at 4 weeks (target >80% achieving castration), and of these, those still castrated at 26 weeks (target >85% maintaining castration).
Key secondary endpoints notably comprised: time to achieve castration; probability of testosterone levels remaining <50 ng/dl between week 4 and week 26; change in prostate-specific antigen (PSA) levels from baseline; proportion of patients with normal PSA levels at 26 weeks compared with baseline.

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.

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.

About Ipsen
Ipsen 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 2013, R&D expenditure totaled close to €250 million, representing more than 20% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 4,600 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. For more information on Ipsen, visit www.ipsen.com.

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