U.S. FDA Approves New Indication for Ipsen's Somatuline® Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline^® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy.

Somatuline^® Depot is also approved for the improvement of progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).¹

Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “The new indication for Somatuline ^® Depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors. It also reaffirms Ipsen’s global commitment to helping to improve lives of patients with cancer.”

"This new indication for Somatuline ^® Depot gives doctors the only somatostatin analog approved by the FDA in adults for both improving progression-free survival in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic GEP-NETs and for the treatment of carcinoid syndrome," said Cynthia Schwalm, Executive Vice-President, and President, North American Commercial Operations, Ipsen. "The additional approval also confirms Ipsen's commitment to developing research-driven treatments intended to help provide patients battling cancer with new therapy options."

The additional Somatuline^® Depot approval for carcinoid syndrome was based on “Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (ELECT): A Randomized, Double-Blind, Placebo-Controlled Trial,” published in Endocrine Practice. ^1,2

IMPORTANT SAFETY INFORMATION

Contraindications

• Somatuline^® Depot 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^® Depot may reduce gallbladder motility and lead to gallstone formation.
  • Periodic monitoring may be needed.

¹ Somatuline Depot (lanreotide) Injection Prescribing Information. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.
² Endocrine Practice, September 2016, Vol. 22, No. 9, pp. 1068-1080

• Hypoglycemia or Hyperglycemia
  • Pharmacological studies show that Somatuline^® Depot, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Patients treated with Somatuline^® Depot may experience hypoglycemia or hyperglycemia.
  • Blood glucose levels should be monitored when Somatuline^® Depot treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
• Cardiovascular Abnormalities
  • Somatuline^® Depot may decrease heart rate.
  • In patients in the GEP-NET pivotal trial, 23% of Somatuline^® Depot-treated patients had a heart rate of less than 60 bpm compared to 16% of placebo-treated patients. The incidence of bradycardia was similar in the treatment groups. Initiate appropriate medical management in patients with symptomatic bradycardia.
  • In patients without underlying cardiac disease, Somatuline^® Depot 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.

Most Common Adverse Reactions

• GEP-NETs: Adverse reactions occurring in greater than 10% of patients who received Somatuline^® Depot in the GEP-NET trial were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).
• Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in greater than 5% of patients who received Somatuline^® Depot in the carcinoid syndrome trial and occurring at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).

Drug Interactions: Somatuline^® Depot may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

• Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at +1-855-463-5127 or FDA at +1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for the full Prescribing Information including Patient Information .

About Ipsen in North America

Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty-driven biopharmaceutical group. The US head office is located in Basking Ridge, New Jersey. Ipsen Biopharmaceuticals Canada, Inc. is an integrated business unit within North America and has its head office located in Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US research and development center focused on the discovery of potentially highly differentiated and competitive products in neurosciences, oncology and rare diseases, is located in Cambridge, Massachusetts. At Ipsen Bioscience, we focus on creating a highly cooperative and passionate R&D organization through partnerships, innovation, and continuous learning to effectively deliver new treatments for patients. At Ipsen, we focus our resources, investments, and energy on discovering, developing, and commercializing new therapeutic options for oncologic, neurologic, and endocrine diseases. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: 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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