Ipsen Announces FDA Approval of a New Delivery Device for Somatuline® Depot® (lanreotide) Injection

BASKING RIDGE, N.J.--()--Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that the U.S. Food and Drug Administration (FDA) has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.

The single use syringe is available in 60 mg, 90 mg and 120 mg dosages. Additional safety features have also been incorporated, including a retractable needle guard, which automatically engages to help avoid needle stick injury, a common hazard for healthcare workers. According to the Centers for Disease Control and Prevention, each year 385,000 needlestick and sharps-related injuries, or an average of approximately 1,000 incidents a day, are sustained by U.S. hospital-based healthcare personnel. The retractable needle in this device was designed with the Needlestick Safety and Prevention Act and accompanying Occupational Safety & Health Administration (OSHA) regulations in mind. Needlestick safety remains a continuing concern of healthcare worker advocacy groups including the American Nurses Association.

The device is manufactured without latex or natural dry rubber, which is important because healthcare workers can develop allergies to these substances over time. The sturdy construction includes a transparent syringe to help verify successful drug delivery, as well as a plunger protector to aid in preventing accidental product loss. When the new device enters the marketplace, each shipment of Somatuline® Depot will be accompanied by robust instructions for use which provide step-by-step instructions to healthcare professionals for proper administration of the product.

The updated design has been available in the EU since January 2012 and will be available in the U.S. beginning in January 2015.

"We are continually looking for ways to better serve those who rely upon our medications," said Cynthia Schwalm, President and CEO of Ipsen Biopharmaceuticals, Inc. "For patients who must get regular injections of Somatuline Depot, and the healthcare professionals that administer their medication, this updated design, incorporating Safe'n'Sound® syringe technology, can help support full dose delivery and help prevent accidental needle sticks, an important benefit for those on the frontlines of delivering care.