BASKING RIDGE, N.J.--(BUSINESS WIRE)--Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext:IPN; ADR:IPSEY), today announced that abstracts of data regarding Somatuline® Depot (lanreotide) Injection 120 mg (referred to as Somatuline®) will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, Illinois, May 29 – June 2, 2015. The data include a poster discussion of a new subgroup analysis of the Phase III CLARINET® study in patients with midgut neuroendocrine tumors (NETs).
“The data being presented at this year’s ASCO meeting demonstrate the continued interest of clinicians in exploring the data from Ipsen-sponsored clinical trials to further examine the effects of lanreotide in treating patients with gastroenteropancreatic neuroendocrine tumors,” said Cynthia Schwalm, President and CEO, Ipsen Biopharmaceuticals, Inc.
Lanreotide Depot/autogel (LAN) in Midgut Neuroendocrine Tumors: A
Subgroup Analysis from the CLARINET Study
- Presenter: Dr. Arvind Dasari, The University of Texas MD Anderson Cancer Center
- Abstract #4104: Poster presentation: Monday June 1, 8:00 a.m. to 11:30 a.m., S Hall A
Association of Progression-Free and Overall Survival (OS) in
Neuroendocrine Tumor Patients (NET) Treated with Somatostatin Analogs
- Presenter: Dr. Monica Ter-Minassian, Dana Farber Cancer Institute
- Abstract #4090: Poster presentation: June 1, 8:00 a.m. to 11:30 a.m., S Hall A
Lanreotide Depot/autogel (LAN) vs. Placebo for Carcinoid Syndrome
in Patients with Neuroendocrine Tumors: A Subgroup Analysis of the
- Presenter: Dr. Aaron Vinik , Eastern Virginia Medical School
- Abstract #4103: Poster presentation: June 1, 8:00 a.m. to 11:30 a.m., S Hall A
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
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 DEPOT 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 pharmaceutical company with total sales exceeding EUR1.2 billion in 2013. One of the leading affiliates is Ipsen Biopharmaceuticals, Inc., the North American arm of Ipsen, headquartered in Basking Ridge, NJ. 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 EUR260 million, representing more than 21% 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, visit www.ipsen.com.
Forward Looking Statements
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Somatuline DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
Safe’n’Sound is a registered trademark of NEMERA LA VERPILLIERE SAS.