BASKING RIDGE, NJ, June 4, 2016 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that Endocrine Practice has published Phase III clinical trial results examining the efficacy and safety of Somatuline® Depot® (lanreotide) Injection 120 mg (referred to as Somatuline®) in patients with carcinoid syndrome. “Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial” is published online at http://www.ncbi.nlm.nih.gov/pubmed/27214300 and will be published in an upcoming print edition.
In the 16-week, Phase III randomized, double-blind, placebo-controlled study of the efficacy and safety of Somatuline® in patients with carcinoid syndrome,115 patients were randomized to Somatuline® 120mg or placebo every four weeks, with access to short-acting octreotide as rescue medication. The study showed the adjusted mean percentage days with rescue octreotide use (the primary endpoint) was lower in the Somatuline® group (33.7 percent) versus the placebo group (48.5 percent) ([95% CI: –26.8, –2.8] p=0.017). The odds ratio of full or partial treatment success (defined as three or fewer days of short-acting octreotide use in weeks 12 to 15) was significantly greater with Somatuline® than placebo (2.4 [95% CI: 1.1, 5.3]; p=0.036). The most common Adverse Events observed in the study were nausea, vomiting, abdominal pain, and flatulence.
“The publication of the ELECT data in Endocrine Practice marks another important milestone for Somatuline® in neuroendocrine tumors,” said Cynthia Schwalm, Chief Executive Officer, Ipsen Biopharmaceuticals, Inc.
Aaron I. Vinik, MD, PhD, Lead Study Author and Director, Neuroendocrine Unit, Eastern Virginia Medical School, Norfolk, VA, said, “The Phase 3 ELECT study further expands our understanding of lanreotide’s potential in patients with neuroendocrine tumors with carcinoid syndrome.”
The CLARINET trial, published in the New England Journal of Medicine in 2014, was the first large Phase III prospective trial to evaluate the antiproliferative effects of Somatuline® in patients with non-functioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs.) The study showed that treatment with Somatuline® significantly prolonged progression-free survival in patients with GEP-NETs compared to treatment with placebo.
About the ELECT Study
In the 16-week,double-blind, Phase-3 trial, patients with or without prior somatostatin analog (SSA) use were randomized to Somatuline® Autogel® 120mg or placebo every four weeks, with access to short-acting octreotide as rescue medication. The primary endpoint was the percentage of days in which short-acting octreotide was used, which was assessed from daily diaries using an analysis of covariance (ANCOVA) including the stratification variables, baseline short-acting octreotide use and frequency of diarrhea/flushing. The proportions of patients experiencing treatment success was a supportive analysis. Adverse events were recorded at all visits.
Somatuline® Depot (lanreotide) Injection 120 mg is indicated for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
Important Safety Information Contraindications:
Somatuline is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions:
- Cholelithiasis and Gallbladder Sludge: Somatuline may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed.
- Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Blood glucose levels should be monitored when Somatuline treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
- Cardiac Abnormalities: Somatuline may decrease heart rate. In 81 patients with baseline heart rates of ≥ 60 beats per minute (bpm) treated with Somatuline in the GEP-NETs clinical trial, the incidence of heart rate < 60 bpm was 23% (19/81) with Somatuline vs 16% (15/94) with placebo; 10 patients (12%) had documented heart rates < 60 bpm on more than one visit. The incidence of documented episodes of heart rate < 50 bpm or bradycardia reported as an adverse event was 1% in
each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia. In patients without underlying cardiac disease, Somatuline may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
• Drug Interactions: The pharmacological gastrointestinal effects of Somatuline may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels.
In the GEP-NET pivotal trial, the most common adverse reactions (incidence >10% and more common than placebo) in patients treated with Somatuline DEPOT vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%). You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.
Please see the full Prescribing Information for Somatuline®Depot by accessing the following link.
Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology. Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients. Ipsen also has a significant presence in primary care. 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, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more than 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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Somatuline DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
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